Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2026-01-05 @ 4:08 AM
Study NCT ID:
NCT02047032
Status:
COMPLETED
Last Update Posted:
2019-06-06
First Post:
2014-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Electroacupuncture Versus PFMT Plus Solifenacin for Mixed Urinary Incontinence
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014549', 'term': 'Urinary Incontinence'}], 'ancestors': [{'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015670', 'term': 'Acupuncture Therapy'}, {'id': 'D015671', 'term': 'Electroacupuncture'}, {'id': 'D000069464', 'term': 'Solifenacin Succinate'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D004561', 'term': 'Transcutaneous Electric Nerve Stimulation'}, {'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D011812', 'term': 'Quinuclidines'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D044005', 'term': 'Tetrahydroisoquinolines'}, {'id': 'D007546', 'term': 'Isoquinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'liuzhishun@aliyun.com', 'phone': '86 88002331', 'title': 'Zhishun Liu', 'organization': "Gunang'anmen Hospital"}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'The noninferiority margin to PFMT-solifenacin in MUI women was hard to define. PFMT were led by trained research assistants instead of professional therapists, which may dilute the effect of the control group.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Electroacupuncture', 'description': 'BL33 and BL35 of both sides are used. Every session will last for 30 minuets and will be given every other day. There are 36 sessions for each participant in all (3 session per week, 12 weeks).\n\nacupuncture: For BL33, the needle (75mm) will be inserted at the point upper and outside of BL33. Insert the needle with a 30-45°angle to a depth of 50-60 mm. The needle will be manipulated with an even lifting, thrusting and twisting method and the sense of soreness and distention will radiate to the perineal region or the anus. For BL35, the needle will be inserted upward and outward slightly with an even lifting, thrusting and twisting method. The sense of soreness and distention will radiate to the perineal region or the anus. The electric stimulator will be put on the two pair of points with a spare-dense wave, 10/50 Hz, 0.1-5.0 mA. The current intensity will be increased until the participant can not stand.', 'otherNumAtRisk': 250, 'otherNumAffected': 41, 'seriousNumAtRisk': 250, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Solifenacin Plus PFMT', 'description': 'Both PFMT and solifenacin will be given for 36 weeks. Solifenacin will be taken 5mg once daily, before or after meal. PFMT includes intensive exercises conducted in hospital and home exercises. Intensive exercises will be done once every week for the first 12 weeks and once every four weeks for the 13th to 36th week. Home exercises will be done three times daily for 36 weeks.\n\nsolifenacin: Solifenacin used in this trial is produced by Astellas Pharma Europe B.V.(Country medicine accurate character No. J20090109 )\n\nPFMT: Intensity of the PFMT exercises will conform to the guideline of National Institute for Health and Clinical Excellence (NICE).', 'otherNumAtRisk': 250, 'otherNumAffected': 90, 'seriousNumAtRisk': 250, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 62, 'numAffected': 62}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'stomach', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'heartburn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'upper respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'hypogeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'blurred vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'low back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'facial edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'subcutaneous hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Change From Baseline in 72-hour Incontinence Episode Frequency (IEF) Over Weeks 1-12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '249', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Solifenacin Plus PFMT', 'description': 'Both PFMT and solifenacin will be given for 36 weeks. Solifenacin will be taken 5mg once daily, before or after meal. PFMT includes intensive exercises conducted in hospital and home exercises. Intensive exercises will be done once every week for the first 12 weeks and once every four weeks for the 13th to 36th week. Home exercises will be done three times daily for 36 weeks.\n\nsolifenacin: Solifenacin used in this trial is produced by Astellas Pharma Europe B.V.(Country medicine accurate character No. J20090109 )\n\nPFMT: Intensity of the PFMT exercises will conform to the guideline of National Institute for Health and Clinical Excellence (NICE).'}, {'id': 'OG001', 'title': 'Electroacupuncture', 'description': 'BL33 and BL35 of both sides are used. Every session will last for 30 minuets and will be given every other day. There are 36 sessions for each participant in all (3 session per week, 12 weeks).\n\nacupuncture: For BL33, the needle (75mm) will be inserted at the point upper and outside of BL33. Insert the needle with a 30-45°angle to a depth of 50-60 mm. The needle will be manipulated with an even lifting, thrusting and twisting method and the sense of soreness and distention will radiate to the perineal region or the anus. For BL35, the needle will be inserted upward and outward slightly with an even lifting, thrusting and twisting method. The sense of soreness and distention will radiate to the perineal region or the anus. The electric stimulator will be put on the two pair of points with a spare-dense wave, 10/50 Hz, 0.1-5.0 mA. The current intensity will be increased until the participant can not stand.'}], 'classes': [{'categories': [{'measurements': [{'value': '-36.49', 'groupId': 'OG000', 'lowerLimit': '-43.87', 'upperLimit': '-29.11'}, {'value': '-37.83', 'groupId': 'OG001', 'lowerLimit': '-41.96', 'upperLimit': '33.70'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline, weeks 1-12', 'description': 'The average 72-h IEF is calculated based on a 72-h bladder diary. All relevant time points used in the calculation in the Time Frame (baseline, weeks 1-12)', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '1 patient withdrew consent and did not receive electroacupuncture treatment, 2 refused to participate and did not receive PFMT-solifenacin treatment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Change From Baseline in Mean 72-hour IEF During Weeks 13-24 and Weeks 25-36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '248', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Electroacupuncture', 'description': 'BL33 and BL35 of both sides are used. Every session will last for 30 minuets and will be given every other day. There are 36 sessions for each participant in all (3 session per week, 12 weeks).\n\nacupuncture: For BL33, the needle (75mm) will be inserted at the point upper and outside of BL33. Insert the needle with a 30-45°angle to a depth of 50-60 mm. The needle will be manipulated with an even lifting, thrusting and twisting method and the sense of soreness and distention will radiate to the perineal region or the anus. For BL35, the needle will be inserted upward and outward slightly with an even lifting, thrusting and twisting method. The sense of soreness and distention will radiate to the perineal region or the anus. The electric stimulator will be put on the two pair of points with a spare-dense wave, 10/50 Hz, 0.1-5.0 mA. The current intensity will be increased until the participant can not stand.'}, {'id': 'OG001', 'title': 'Solifenacin Plus PFMT', 'description': 'Both PFMT and solifenacin will be given for 36 weeks. Solifenacin will be taken 5mg once daily, before or after meal. PFMT includes intensive exercises conducted in hospital and home exercises. Intensive exercises will be done once every week for the first 12 weeks and once every four weeks for the 13th to 36th week. Home exercises will be done three times daily for 36 weeks.\n\nsolifenacin: Solifenacin used in this trial is produced by Astellas Pharma Europe B.V.(Country medicine accurate character No. J20090109 )\n\nPFMT: Intensity of the PFMT exercises will conform to the guideline of National Institute for Health and Clinical Excellence (NICE).'}], 'classes': [{'title': 'Weeks 13-24', 'categories': [{'measurements': [{'value': '-58.20', 'groupId': 'OG000', 'lowerLimit': '-63.19', 'upperLimit': '-53.22'}, {'value': '-56.69', 'groupId': 'OG001', 'lowerLimit': '-61.77', 'upperLimit': '-51.61'}]}]}, {'title': 'Weeks 25-36', 'categories': [{'measurements': [{'value': '-64.20', 'groupId': 'OG000', 'lowerLimit': '-68.77', 'upperLimit': '-59.63'}, {'value': '-65.48', 'groupId': 'OG001', 'lowerLimit': '-70.14', 'upperLimit': '-60.82'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline, weeks 13-24, week 25-36', 'description': 'Calculated as the same way as the primary outcome. But this outcome will be assessed at different time point.', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '1 patient withdrew consent and did not receive electroacupuncture treatment, 2 refused to participate and did not receive PFMT-solifenacin treatment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With ≥50% Decrease in Average 72-h Incontinence Episode Frequency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '248', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Electroacupuncture', 'description': 'BL33 and BL35 of both sides are used. Every session will last for 30 minuets and will be given every other day. There are 36 sessions for each participant in all (3 session per week, 12 weeks).\n\nacupuncture: For BL33, the needle (75mm) will be inserted at the point upper and outside of BL33. Insert the needle with a 30-45°angle to a depth of 50-60 mm. The needle will be manipulated with an even lifting, thrusting and twisting method and the sense of soreness and distention will radiate to the perineal region or the anus. For BL35, the needle will be inserted upward and outward slightly with an even lifting, thrusting and twisting method. The sense of soreness and distention will radiate to the perineal region or the anus. The electric stimulator will be put on the two pair of points with a spare-dense wave, 10/50 Hz, 0.1-5.0 mA. The current intensity will be increased until the participant can not stand.'}, {'id': 'OG001', 'title': 'Solifenacin Plus PFMT', 'description': 'Both PFMT and solifenacin will be given for 36 weeks. Solifenacin will be taken 5mg once daily, before or after meal. PFMT includes intensive exercises conducted in hospital and home exercises. Intensive exercises will be done once every week for the first 12 weeks and once every four weeks for the 13th to 36th week. Home exercises will be done three times daily for 36 weeks.\n\nsolifenacin: Solifenacin used in this trial is produced by Astellas Pharma Europe B.V.(Country medicine accurate character No. J20090109 )\n\nPFMT: Intensity of the PFMT exercises will conform to the guideline of National Institute for Health and Clinical Excellence (NICE).'}], 'classes': [{'title': 'Weeks 1-12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '239', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '109', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}]}, {'title': 'Weeks 13-24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '245', 'groupId': 'OG000'}, {'value': '235', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '174', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}]}, {'title': 'Weeks 25-36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '245', 'groupId': 'OG000'}, {'value': '235', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '190', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Weeks 1-12, 13-24, 25-36', 'description': 'Count the number of cases with the reduction of average 72-h incontinence episode frequency ≥50% and divide it by the number of participants at baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'For various reasons, participants discontinued study.'}, {'type': 'SECONDARY', 'title': 'Change of Episodes From Baseline in Average 72-hour Urgencies/Urination/Nocturia Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '248', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Electroacupuncture', 'description': 'BL33 and BL35 of both sides are used. Every session will last for 30 minuets and will be given every other day. There are 36 sessions for each participant in all (3 session per week, 12 weeks).\n\nacupuncture: For BL33, the needle (75mm) will be inserted at the point upper and outside of BL33. Insert the needle with a 30-45°angle to a depth of 50-60 mm. The needle will be manipulated with an even lifting, thrusting and twisting method and the sense of soreness and distention will radiate to the perineal region or the anus. For BL35, the needle will be inserted upward and outward slightly with an even lifting, thrusting and twisting method. The sense of soreness and distention will radiate to the perineal region or the anus. The electric stimulator will be put on the two pair of points with a spare-dense wave, 10/50 Hz, 0.1-5.0 mA. The current intensity will be increased until the participant can not stand.'}, {'id': 'OG001', 'title': 'Solifenacin Plus PFMT', 'description': 'Both PFMT and solifenacin will be given for 36 weeks. Solifenacin will be taken 5mg once daily, before or after meal. PFMT includes intensive exercises conducted in hospital and home exercises. Intensive exercises will be done once every week for the first 12 weeks and once every four weeks for the 13th to 36th week. Home exercises will be done three times daily for 36 weeks.\n\nsolifenacin: Solifenacin used in this trial is produced by Astellas Pharma Europe B.V.(Country medicine accurate character No. J20090109 )\n\nPFMT: Intensity of the PFMT exercises will conform to the guideline of National Institute for Health and Clinical Excellence (NICE).'}], 'classes': [{'title': 'Change in the 72-h urgence, Weeks 1-12', 'categories': [{'measurements': [{'value': '-2.62', 'groupId': 'OG000', 'lowerLimit': '-3.20', 'upperLimit': '-2.05'}, {'value': '-2.99', 'groupId': 'OG001', 'lowerLimit': '-3.58', 'upperLimit': '-2.41'}]}]}, {'title': 'Change in the 72-h urgence, Weeks 13-24', 'categories': [{'measurements': [{'value': '-4.75', 'groupId': 'OG000', 'lowerLimit': '-5.32', 'upperLimit': '-4.19'}, {'value': '-4.77', 'groupId': 'OG001', 'lowerLimit': '-5.35', 'upperLimit': '-4.19'}]}]}, {'title': 'Change in the 72-h urgence, Weeks 25-36', 'categories': [{'measurements': [{'value': '-5.55', 'groupId': 'OG000', 'lowerLimit': '-6.12', 'upperLimit': '-4.97'}, {'value': '-5.55', 'groupId': 'OG001', 'lowerLimit': '-6.14', 'upperLimit': '-4.96'}]}]}, {'title': 'Change in the 72-h urination, Weeks 1-12', 'categories': [{'measurements': [{'value': '-3.23', 'groupId': 'OG000', 'lowerLimit': '-3.93', 'upperLimit': '-2.53'}, {'value': '-3.62', 'groupId': 'OG001', 'lowerLimit': '-4.33', 'upperLimit': '-2.91'}]}]}, {'title': 'Change in the 72-h urination, Weeks 13-24', 'categories': [{'measurements': [{'value': '-5.96', 'groupId': 'OG000', 'lowerLimit': '-6.70', 'upperLimit': '-5.22'}, {'value': '-5.26', 'groupId': 'OG001', 'lowerLimit': '-6.02', 'upperLimit': '-4.51'}]}]}, {'title': 'Change in the 72-h urination, Weeks 25-36', 'categories': [{'measurements': [{'value': '-7.02', 'groupId': 'OG000', 'lowerLimit': '-7.85', 'upperLimit': '-6.19'}, {'value': '-6.11', 'groupId': 'OG001', 'lowerLimit': '-6.96', 'upperLimit': '-5.26'}]}]}, {'title': 'Change in the 72-h nocturia, Weeks 1-12', 'categories': [{'measurements': [{'value': '-0.79', 'groupId': 'OG000', 'lowerLimit': '-1.01', 'upperLimit': '-0.50'}, {'value': '-0.87', 'groupId': 'OG001', 'lowerLimit': '-1.08', 'upperLimit': '-0.65'}]}]}, {'title': 'Change in the 72-h nocturia, Weeks 13-24', 'categories': [{'measurements': [{'value': '-1.38', 'groupId': 'OG000', 'lowerLimit': '-1.60', 'upperLimit': '-1.15'}, {'value': '-1.33', 'groupId': 'OG001', 'lowerLimit': '-1.56', 'upperLimit': '-1.11'}]}]}, {'title': 'Change in the 72-h nocturia, Weeks 25-36', 'categories': [{'measurements': [{'value': '-1.58', 'groupId': 'OG000', 'lowerLimit': '-1.79', 'upperLimit': '-1.36'}, {'value': '-1.58', 'groupId': 'OG001', 'lowerLimit': '-1.80', 'upperLimit': '-1.36'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, weeks 1-12, 13-24, 25-36', 'description': 'The average 72-h IEF (urinary incontinence, stress urinary incontinence and urgency urinary incontinence respectively) is calculated based on a 72-h bladder diary. For example, the average 72-h incontinence episodes from the 13th to 36th week equal to the sum of 72-h incontinence episodes of the 16th, 20th, 24th, 28th, 32nd, 36th weeks divided by 6.', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '1 patient withdrew consent and did not receive electroacupuncture treatment, 2 refused to participate and did not receive PFMT-solifenacin treatment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '248', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Electroacupuncture', 'description': 'BL33 and BL35 of both sides are used. Every session will last for 30 minuets and will be given every other day. There are 36 sessions for each participant in all (3 session per week, 12 weeks).\n\nacupuncture: For BL33, the needle (75mm) will be inserted at the point upper and outside of BL33. Insert the needle with a 30-45°angle to a depth of 50-60 mm. The needle will be manipulated with an even lifting, thrusting and twisting method and the sense of soreness and distention will radiate to the perineal region or the anus. For BL35, the needle will be inserted upward and outward slightly with an even lifting, thrusting and twisting method. The sense of soreness and distention will radiate to the perineal region or the anus. The electric stimulator will be put on the two pair of points with a spare-dense wave, 10/50 Hz, 0.1-5.0 mA. The current intensity will be increased until the participant can not stand.'}, {'id': 'OG001', 'title': 'Solifenacin Plus PFMT', 'description': 'Both PFMT and solifenacin will be given for 36 weeks. Solifenacin will be taken 5mg once daily, before or after meal. PFMT includes intensive exercises conducted in hospital and home exercises. Intensive exercises will be done once every week for the first 12 weeks and once every four weeks for the 13th to 36th week. Home exercises will be done three times daily for 36 weeks.\n\nsolifenacin: Solifenacin used in this trial is produced by Astellas Pharma Europe B.V.(Country medicine accurate character No. J20090109 )\n\nPFMT: Intensity of the PFMT exercises will conform to the guideline of National Institute for Health and Clinical Excellence (NICE).'}], 'classes': [{'title': 'Week 12', 'categories': [{'measurements': [{'value': '-3.96', 'groupId': 'OG000', 'lowerLimit': '-4.32', 'upperLimit': '-3.61'}, {'value': '-3.73', 'groupId': 'OG001', 'lowerLimit': '-4.09', 'upperLimit': '-3.37'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '-6.44', 'groupId': 'OG000', 'lowerLimit': '-6.90', 'upperLimit': '-5.98'}, {'value': '-5.97', 'groupId': 'OG001', 'lowerLimit': '-6.44', 'upperLimit': '-5.50'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '-7.06', 'groupId': 'OG000', 'lowerLimit': '-7.51', 'upperLimit': '-6.60'}, {'value': '-6.80', 'groupId': 'OG001', 'lowerLimit': '-7.26', 'upperLimit': '-6.34'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline, weeks 12, 24 and 36', 'description': 'The International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF (range, 0 \\[best\\]-21 \\[worst\\] outcomes, and 2.52 as minimal clinically important differences (MCID)) scores.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Weekly Median Number of Urine Pads Used During Weeks 1-12, 13-24, and 25-36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '248', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Electroacupuncture', 'description': 'BL33 and BL35 of both sides are used. Every session will last for 30 minuets and will be given every other day. There are 36 sessions for each participant in all (3 session per week, 12 weeks).\n\nacupuncture: For BL33, the needle (75mm) will be inserted at the point upper and outside of BL33. Insert the needle with a 30-45°angle to a depth of 50-60 mm. The needle will be manipulated with an even lifting, thrusting and twisting method and the sense of soreness and distention will radiate to the perineal region or the anus. For BL35, the needle will be inserted upward and outward slightly with an even lifting, thrusting and twisting method. The sense of soreness and distention will radiate to the perineal region or the anus. The electric stimulator will be put on the two pair of points with a spare-dense wave, 10/50 Hz, 0.1-5.0 mA. The current intensity will be increased until the participant can not stand.'}, {'id': 'OG001', 'title': 'Solifenacin Plus PFMT', 'description': 'Both PFMT and solifenacin will be given for 36 weeks. Solifenacin will be taken 5mg once daily, before or after meal. PFMT includes intensive exercises conducted in hospital and home exercises. Intensive exercises will be done once every week for the first 12 weeks and once every four weeks for the 13th to 36th week. Home exercises will be done three times daily for 36 weeks.\n\nsolifenacin: Solifenacin used in this trial is produced by Astellas Pharma Europe B.V.(Country medicine accurate character No. J20090109 )\n\nPFMT: Intensity of the PFMT exercises will conform to the guideline of National Institute for Health and Clinical Excellence (NICE).'}], 'classes': [{'title': 'Weeks 1-12', 'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000', 'lowerLimit': '5.0', 'upperLimit': '11.0'}, {'value': '9.0', 'groupId': 'OG001', 'lowerLimit': '5.0', 'upperLimit': '12.0'}]}]}, {'title': 'Weeks 13-24', 'categories': [{'measurements': [{'value': '7.0', 'groupId': 'OG000', 'lowerLimit': '4.0', 'upperLimit': '10.0'}, {'value': '8.0', 'groupId': 'OG001', 'lowerLimit': '5.0', 'upperLimit': '12.0'}]}]}, {'title': 'Weeks 25-36', 'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000', 'lowerLimit': '4.0', 'upperLimit': '10.0'}, {'value': '8.0', 'groupId': 'OG001', 'lowerLimit': '5.0', 'upperLimit': '12.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, weeks 1-12, 13-24, 25-36', 'unitOfMeasure': 'urine pads', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '1 patient withdrew consent and did not receive electroacupuncture treatment, 2 refused to participate and did not receive PFMT-solifenacin treatment.'}, {'type': 'SECONDARY', 'title': 'the Amount of Urine Leakage (Grams) Measured by the 1-hour Pad Test at Weeks 4 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '248', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Electroacupuncture', 'description': 'BL33 and BL35 of both sides are used. Every session will last for 30 minuets and will be given every other day. There are 36 sessions for each participant in all (3 session per week, 12 weeks).\n\nacupuncture: For BL33, the needle (75mm) will be inserted at the point upper and outside of BL33. Insert the needle with a 30-45°angle to a depth of 50-60 mm. The needle will be manipulated with an even lifting, thrusting and twisting method and the sense of soreness and distention will radiate to the perineal region or the anus. For BL35, the needle will be inserted upward and outward slightly with an even lifting, thrusting and twisting method. The sense of soreness and distention will radiate to the perineal region or the anus. The electric stimulator will be put on the two pair of points with a spare-dense wave, 10/50 Hz, 0.1-5.0 mA. The current intensity will be increased until the participant can not stand.'}, {'id': 'OG001', 'title': 'Solifenacin Plus PFMT', 'description': 'Both PFMT and solifenacin will be given for 36 weeks. Solifenacin will be taken 5mg once daily, before or after meal. PFMT includes intensive exercises conducted in hospital and home exercises. Intensive exercises will be done once every week for the first 12 weeks and once every four weeks for the 13th to 36th week. Home exercises will be done three times daily for 36 weeks.\n\nsolifenacin: Solifenacin used in this trial is produced by Astellas Pharma Europe B.V.(Country medicine accurate character No. J20090109 )\n\nPFMT: Intensity of the PFMT exercises will conform to the guideline of National Institute for Health and Clinical Excellence (NICE).'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '-6.74', 'groupId': 'OG000', 'lowerLimit': '-7.93', 'upperLimit': '-5.56'}, {'value': '-6.96', 'groupId': 'OG001', 'lowerLimit': '-8.17', 'upperLimit': '-5.76'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-12.16', 'groupId': 'OG000', 'lowerLimit': '-13.18', 'upperLimit': '-11.15'}, {'value': '-11.49', 'groupId': 'OG001', 'lowerLimit': '-12.52', 'upperLimit': '-10.46'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Weeks 4 and 12', 'description': 'The performance of 1-hour pad test according to the International Incontinence Society:\n\nParticipants were instructed to void 2 hours before the pad test. On arrival, they received a pre-weighed pad and were asked to sit and drink 500 ml sodium-free water in 15 minutes. Next, they were instructed to walk for 30 minutes, including going up and down 24 stairs. On returning to the clinic, the participants were instructed to perform several activities, including standing and sitting 10 times, coughing vigorously 10 times, running for 1 minute, picking up a coin from the floor 5 times, and putting their hands under water for 1 minute. After the activities were completed, the pad was reweighed to measure the amount of urinary leakage using a gram sensitive weight scale (Xiangshan, EK3820).', 'unitOfMeasure': 'amount of leakage (grams)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '1 patient withdrew consent and did not receive electroacupuncture treatment, 2 refused to participate and did not receive PFMT-solifenacin treatment.'}, {'type': 'SECONDARY', 'title': "Patient's Treatment Satisfaction Degree", 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '249', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Solifenacin Plus PFMT', 'description': 'Both PFMT and solifenacin will be given for 36 weeks. Solifenacin will be taken 5mg once daily, before or after meal. PFMT includes intensive exercises conducted in hospital and home exercises. Intensive exercises will be done once every week for the first 12 weeks and once every four weeks for the 13th to 36th week. Home exercises will be done three times daily for 36 weeks.\n\nsolifenacin: Solifenacin used in this trial is produced by Astellas Pharma Europe B.V.(Country medicine accurate character No. J20090109 )\n\nPFMT: Intensity of the PFMT exercises will conform to the guideline of National Institute for Health and Clinical Excellence (NICE).'}, {'id': 'OG001', 'title': 'Electroacupuncture', 'description': 'BL33 and BL35 of both sides are used. Every session will last for 30 minuets and will be given every other day. There are 36 sessions for each participant in all (3 session per week, 12 weeks).\n\nacupuncture: For BL33, the needle (75mm) will be inserted at the point upper and outside of BL33. Insert the needle with a 30-45°angle to a depth of 50-60 mm. The needle will be manipulated with an even lifting, thrusting and twisting method and the sense of soreness and distention will radiate to the perineal region or the anus. For BL35, the needle will be inserted upward and outward slightly with an even lifting, thrusting and twisting method. The sense of soreness and distention will radiate to the perineal region or the anus. The electric stimulator will be put on the two pair of points with a spare-dense wave, 10/50 Hz, 0.1-5.0 mA. The current intensity will be increased until the participant can not stand.'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Marked satisfaction', 'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}, {'title': 'Satisfaction', 'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}, {'title': 'No change', 'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}, {'title': 'Dissatisfaction', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}, {'title': 'Marked dissatisfaction', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '244', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Marked satisfaction', 'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}, {'title': 'Satisfaction', 'measurements': [{'value': '90', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}, {'title': 'No change', 'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}, {'title': 'Dissatisfaction', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}, {'title': 'Marked dissatisfaction', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Weeks 12, 36', 'description': 'The self-assessing satisfaction degree on a 5-point Likert scale (range, 1 \\[unsatisfied strongly\\] to 5 \\[satisfied strongly\\]) will be finished by participants to evaluate their satisfaction for the treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '1 patient withdrew consent and did not receive electroacupuncture treatment. 2 refused to participate and did not receive PFMT-solifenacin treatment.'}, {'type': 'SECONDARY', 'title': 'Patient Global Impression Improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '248', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Electroacupuncture', 'description': 'BL33 and BL35 of both sides are used. Every session will last for 30 minuets and will be given every other day. There are 36 sessions for each participant in all (3 session per week, 12 weeks).\n\nacupuncture: For BL33, the needle (75mm) will be inserted at the point upper and outside of BL33. Insert the needle with a 30-45°angle to a depth of 50-60 mm. The needle will be manipulated with an even lifting, thrusting and twisting method and the sense of soreness and distention will radiate to the perineal region or the anus. For BL35, the needle will be inserted upward and outward slightly with an even lifting, thrusting and twisting method. The sense of soreness and distention will radiate to the perineal region or the anus. The electric stimulator will be put on the two pair of points with a spare-dense wave, 10/50 Hz, 0.1-5.0 mA. The current intensity will be increased until the participant can not stand.'}, {'id': 'OG001', 'title': 'Solifenacin Plus PFMT', 'description': 'Both PFMT and solifenacin will be given for 36 weeks. Solifenacin will be taken 5mg once daily, before or after meal. PFMT includes intensive exercises conducted in hospital and home exercises. Intensive exercises will be done once every week for the first 12 weeks and once every four weeks for the 13th to 36th week. Home exercises will be done three times daily for 36 weeks.\n\nsolifenacin: Solifenacin used in this trial is produced by Astellas Pharma Europe B.V.(Country medicine accurate character No. J20090109 )\n\nPFMT: Intensity of the PFMT exercises will conform to the guideline of National Institute for Health and Clinical Excellence (NICE).'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '244', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Marked improvement', 'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}, {'title': 'Moderate improvement', 'measurements': [{'value': '85', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}, {'title': 'Slight improvement', 'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}, {'title': 'No change', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}, {'title': 'Slight worsening', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Moderate worsening', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Marked worening', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '245', 'groupId': 'OG000'}, {'value': '235', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Marked improvement', 'measurements': [{'value': '87', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}, {'title': 'Moderate improvement', 'measurements': [{'value': '93', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}, {'title': 'Slight improvement', 'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}, {'title': 'No change', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}, {'title': 'Slight worsening', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Moderate worsening', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Marked worening', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Weeks 12, 36', 'description': 'Participants will be asked to finish one item evaluating their present condition.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '1 patient withdrew consent and did not receive electroacupuncture treatment, 2 refused to participate and did not receive PFMT-solifenacin treatment.'}, {'type': 'SECONDARY', 'title': 'Electroacupuncture Acceptance Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Electroacupuncture', 'description': 'BL33 and BL35 of both sides are used. Every session will last for 30 minuets and will be given every other day. There are 36 sessions for each participant in all (3 session per week, 12 weeks).\n\nacupuncture: For BL33, the needle (75mm) will be inserted at the point upper and outside of BL33. Insert the needle with a 30-45°angle to a depth of 50-60 mm. The needle will be manipulated with an even lifting, thrusting and twisting method and the sense of soreness and distention will radiate to the perineal region or the anus. For BL35, the needle will be inserted upward and outward slightly with an even lifting, thrusting and twisting method. The sense of soreness and distention will radiate to the perineal region or the anus. The electric stimulator will be put on the two pair of points with a spare-dense wave, 10/50 Hz, 0.1-5.0 mA. The current intensity will be increased until the participant can not stand.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '3.0'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '3.0'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '3.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Weeks 2, 6 and 12', 'description': "The acceptance of electroacupuncture will be tested within 5 minute with a 5-point scale ('0' means very difficult to accept and '4' means accept easily). Median of scores of the three times will be calculated.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '1 patient withdrew consent and did not receive electroacupuncture treatment.'}, {'type': 'SECONDARY', 'title': 'The Number of Participants Using Urine Pads', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '248', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Electroacupuncture', 'description': 'BL33 and BL35 of both sides are used. Every session will last for 30 minuets and will be given every other day. There are 36 sessions for each participant in all (3 session per week, 12 weeks).\n\nacupuncture: For BL33, the needle (75mm) will be inserted at the point upper and outside of BL33. Insert the needle with a 30-45°angle to a depth of 50-60 mm. The needle will be manipulated with an even lifting, thrusting and twisting method and the sense of soreness and distention will radiate to the perineal region or the anus. For BL35, the needle will be inserted upward and outward slightly with an even lifting, thrusting and twisting method. The sense of soreness and distention will radiate to the perineal region or the anus. The electric stimulator will be put on the two pair of points with a spare-dense wave, 10/50 Hz, 0.1-5.0 mA. The current intensity will be increased until the participant can not stand.'}, {'id': 'OG001', 'title': 'Solifenacin Plus PFMT', 'description': 'Both PFMT and solifenacin will be given for 36 weeks. Solifenacin will be taken 5mg once daily, before or after meal. PFMT includes intensive exercises conducted in hospital and home exercises. Intensive exercises will be done once every week for the first 12 weeks and once every four weeks for the 13th to 36th week. Home exercises will be done three times daily for 36 weeks.\n\nsolifenacin: Solifenacin used in this trial is produced by Astellas Pharma Europe B.V.(Country medicine accurate character No. J20090109 )\n\nPFMT: Intensity of the PFMT exercises will conform to the guideline of National Institute for Health and Clinical Excellence (NICE).'}], 'classes': [{'title': 'Weeks 1-12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}]}, {'title': 'Weeks 13-24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '244', 'groupId': 'OG000'}, {'value': '237', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}]}, {'title': 'Weeks 25-36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '244', 'groupId': 'OG000'}, {'value': '237', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Weeks 1-12, 13-24, 25-36', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'For various reasons, the participants discontinued study.'}, {'type': 'SECONDARY', 'title': 'Change of Episodes From Baseline in Mean 72-h Incontinence Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '248', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Electroacupuncture', 'description': 'BL33 and BL35 of both sides are used. Every session will last for 30 minuets and will be given every other day. There are 36 sessions for each participant in all (3 session per week, 12 weeks).\n\nacupuncture: For BL33, the needle (75mm) will be inserted at the point upper and outside of BL33. Insert the needle with a 30-45°angle to a depth of 50-60 mm. The needle will be manipulated with an even lifting, thrusting and twisting method and the sense of soreness and distention will radiate to the perineal region or the anus. For BL35, the needle will be inserted upward and outward slightly with an even lifting, thrusting and twisting method. The sense of soreness and distention will radiate to the perineal region or the anus. The electric stimulator will be put on the two pair of points with a spare-dense wave, 10/50 Hz, 0.1-5.0 mA. The current intensity will be increased until the participant can not stand.'}, {'id': 'OG001', 'title': 'Solifenacin Plus PFMT', 'description': 'Both PFMT and solifenacin will be given for 36 weeks. Solifenacin will be taken 5mg once daily, before or after meal. PFMT includes intensive exercises conducted in hospital and home exercises. Intensive exercises will be done once every week for the first 12 weeks and once every four weeks for the 13th to 36th week. Home exercises will be done three times daily for 36 weeks.\n\nsolifenacin: Solifenacin used in this trial is produced by Astellas Pharma Europe B.V.(Country medicine accurate character No. J20090109 )\n\nPFMT: Intensity of the PFMT exercises will conform to the guideline of National Institute for Health and Clinical Excellence (NICE).'}], 'classes': [{'title': 'Weeks 1-12', 'categories': [{'measurements': [{'value': '-4.56', 'groupId': 'OG000', 'lowerLimit': '-5.13', 'upperLimit': '-3.98'}, {'value': '-4.37', 'groupId': 'OG001', 'lowerLimit': '-4.95', 'upperLimit': '-3.79'}]}]}, {'title': 'Weeks 13-24', 'categories': [{'measurements': [{'value': '-7.27', 'groupId': 'OG000', 'lowerLimit': '-7.83', 'upperLimit': '-6.70'}, {'value': '-6.95', 'groupId': 'OG001', 'lowerLimit': '-7.52', 'upperLimit': '-6.37'}]}]}, {'title': 'Weeks 25-36', 'categories': [{'measurements': [{'value': '-8.31', 'groupId': 'OG000', 'lowerLimit': '-8.83', 'upperLimit': '-7.78'}, {'value': '-8.22', 'groupId': 'OG001', 'lowerLimit': '-8.76', 'upperLimit': '-7.69'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Weeks 1-12, 13-24, 25-36', 'unitOfMeasure': 'episodes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '1 patient withdrew consent and did not receive electroacupuncture treatment, 2 refused to participate and did not receive PFMT-solifenacin treatment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Acupuncture', 'description': 'BL33 and BL35 of both sides are used. Every session will last for 30 minuets and will be given every other day. There are 36 sessions for each participant in all (3 session per week, 12 weeks).\n\nacupuncture: For BL33, the needle (75mm) will be inserted at the point upper and outside of BL33. Insert the needle with a 30-45°angle to a depth of 50-60 mm. The needle will be manipulated with an even lifting, thrusting and twisting method and the sense of soreness and distention will radiate to the perineal region or the anus. For BL35, the needle will be inserted upward and outward slightly with an even lifting, thrusting and twisting method. The sense of soreness and distention will radiate to the perineal region or the anus. The electric stimulator will be put on the two pair of points with a spare-dense wave, 10/50 Hz, 0.1-5.0 mA. The current intensity will be increased until the participant can not stand.'}, {'id': 'FG001', 'title': 'Solifenacin Plus PFMT', 'description': 'Both PFMT and solifenacin will be given for 36 weeks. Solifenacin will be taken 5mg once daily, before or after meal. PFMT includes intensive exercises conducted in hospital and home exercises. Intensive exercises will be done once every week for the first 12 weeks and once every four weeks for the 13th to 36th week. Home exercises will be done three times daily for 36 weeks.\n\nsolifenacin: Solifenacin used in this trial is produced by Astellas Pharma Europe B.V.(Country medicine accurate character No. J20090109 )\n\nPFMT: Intensity of the PFMT exercises will conform to the guideline of National Institute for Health and Clinical Excellence (NICE).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '250'}, {'groupId': 'FG001', 'numSubjects': '250'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '245'}, {'groupId': 'FG001', 'numSubjects': '235'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '15'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '250', 'groupId': 'BG000'}, {'value': '250', 'groupId': 'BG001'}, {'value': '500', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Acupuncture', 'description': 'BL33 and BL35 of both sides are used. Every session will last for 30 minuets and will be given every other day. There are 36 sessions for each participant in all (3 session per week, 12 weeks).\n\nacupuncture: For BL33, the needle (75mm) will be inserted at the point upper and outside of BL33. Insert the needle with a 30-45°angle to a depth of 50-60 mm. The needle will be manipulated with an even lifting, thrusting and twisting method and the sense of soreness and distention will radiate to the perineal region or the anus. For BL35, the needle will be inserted upward and outward slightly with an even lifting, thrusting and twisting method. The sense of soreness and distention will radiate to the perineal region or the anus. The electric stimulator will be put on the two pair of points with a spare-dense wave, 10/50 Hz, 0.1-5.0 mA. The current intensity will be increased until the participant can not stand.'}, {'id': 'BG001', 'title': 'Solifenacin Plus PFMT', 'description': 'Both PFMT and solifenacin will be given for 36 weeks. Solifenacin will be taken 5mg once daily, before or after meal. PFMT includes intensive exercises conducted in hospital and home exercises. Intensive exercises will be done once every week for the first 12 weeks and once every four weeks for the 13th to 36th week. Home exercises will be done three times daily for 36 weeks.\n\nsolifenacin: Solifenacin used in this trial is produced by Astellas Pharma Europe B.V.(Country medicine accurate character No. J20090109 )\n\nPFMT: Intensity of the PFMT exercises will conform to the guideline of National Institute for Health and Clinical Excellence (NICE).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.7', 'spread': '10.11', 'groupId': 'BG000'}, {'value': '53.7', 'spread': '9.38', 'groupId': 'BG001'}, {'value': '54.2', 'spread': '9.75', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '250', 'groupId': 'BG000'}, {'value': '250', 'groupId': 'BG001'}, {'value': '500', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-03', 'studyFirstSubmitDate': '2014-01-23', 'resultsFirstSubmitDate': '2018-02-14', 'studyFirstSubmitQcDate': '2014-01-25', 'lastUpdatePostDateStruct': {'date': '2019-06-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-03-03', 'studyFirstPostDateStruct': {'date': '2014-01-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Change From Baseline in 72-hour Incontinence Episode Frequency (IEF) Over Weeks 1-12', 'timeFrame': 'baseline, weeks 1-12', 'description': 'The average 72-h IEF is calculated based on a 72-h bladder diary. All relevant time points used in the calculation in the Time Frame (baseline, weeks 1-12)'}], 'secondaryOutcomes': [{'measure': 'Percentage of Change From Baseline in Mean 72-hour IEF During Weeks 13-24 and Weeks 25-36', 'timeFrame': 'baseline, weeks 13-24, week 25-36', 'description': 'Calculated as the same way as the primary outcome. But this outcome will be assessed at different time point.'}, {'measure': 'Percentage of Participants With ≥50% Decrease in Average 72-h Incontinence Episode Frequency', 'timeFrame': 'Weeks 1-12, 13-24, 25-36', 'description': 'Count the number of cases with the reduction of average 72-h incontinence episode frequency ≥50% and divide it by the number of participants at baseline.'}, {'measure': 'Change of Episodes From Baseline in Average 72-hour Urgencies/Urination/Nocturia Episodes', 'timeFrame': 'Baseline, weeks 1-12, 13-24, 25-36', 'description': 'The average 72-h IEF (urinary incontinence, stress urinary incontinence and urgency urinary incontinence respectively) is calculated based on a 72-h bladder diary. For example, the average 72-h incontinence episodes from the 13th to 36th week equal to the sum of 72-h incontinence episodes of the 16th, 20th, 24th, 28th, 32nd, 36th weeks divided by 6.'}, {'measure': 'Change From Baseline in the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) Score', 'timeFrame': 'baseline, weeks 12, 24 and 36', 'description': 'The International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF (range, 0 \\[best\\]-21 \\[worst\\] outcomes, and 2.52 as minimal clinically important differences (MCID)) scores.'}, {'measure': 'Weekly Median Number of Urine Pads Used During Weeks 1-12, 13-24, and 25-36', 'timeFrame': 'Baseline, weeks 1-12, 13-24, 25-36'}, {'measure': 'the Amount of Urine Leakage (Grams) Measured by the 1-hour Pad Test at Weeks 4 and 12', 'timeFrame': 'Weeks 4 and 12', 'description': 'The performance of 1-hour pad test according to the International Incontinence Society:\n\nParticipants were instructed to void 2 hours before the pad test. On arrival, they received a pre-weighed pad and were asked to sit and drink 500 ml sodium-free water in 15 minutes. Next, they were instructed to walk for 30 minutes, including going up and down 24 stairs. On returning to the clinic, the participants were instructed to perform several activities, including standing and sitting 10 times, coughing vigorously 10 times, running for 1 minute, picking up a coin from the floor 5 times, and putting their hands under water for 1 minute. After the activities were completed, the pad was reweighed to measure the amount of urinary leakage using a gram sensitive weight scale (Xiangshan, EK3820).'}, {'measure': "Patient's Treatment Satisfaction Degree", 'timeFrame': 'Weeks 12, 36', 'description': 'The self-assessing satisfaction degree on a 5-point Likert scale (range, 1 \\[unsatisfied strongly\\] to 5 \\[satisfied strongly\\]) will be finished by participants to evaluate their satisfaction for the treatment.'}, {'measure': 'Patient Global Impression Improvement', 'timeFrame': 'Weeks 12, 36', 'description': 'Participants will be asked to finish one item evaluating their present condition.'}, {'measure': 'Electroacupuncture Acceptance Assessment', 'timeFrame': 'Weeks 2, 6 and 12', 'description': "The acceptance of electroacupuncture will be tested within 5 minute with a 5-point scale ('0' means very difficult to accept and '4' means accept easily). Median of scores of the three times will be calculated."}, {'measure': 'The Number of Participants Using Urine Pads', 'timeFrame': 'Weeks 1-12, 13-24, 25-36'}, {'measure': 'Change of Episodes From Baseline in Mean 72-h Incontinence Episodes', 'timeFrame': 'Weeks 1-12, 13-24, 25-36'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['electroacupuncture', 'urinary incontinence', 'PFMT', 'Solifenacin'], 'conditions': ['Urinary Incontinence']}, 'referencesModule': {'references': [{'pmid': '36148895', 'type': 'DERIVED', 'citation': 'Hargreaves E, Baker K, Barry G, Harding C, Zhang Y, Kandala NB, Zhang X, Kernohan A, Clarkson CE. Acupuncture for treating overactive bladder in adults. Cochrane Database Syst Rev. 2022 Sep 23;9(9):CD013519. doi: 10.1002/14651858.CD013519.pub2.'}, {'pmid': '31919102', 'type': 'DERIVED', 'citation': 'Sun B, Liu Y, Su T, Sun Y, Liu Z. Electroacupuncture for stress-related urinary incontinence in elderly women: data analysis from two randomised controlled studies. BMJ Support Palliat Care. 2022 May;12(e1):e164-e170. doi: 10.1136/bmjspcare-2019-002034. Epub 2020 Jan 9.'}, {'pmid': '30611454', 'type': 'DERIVED', 'citation': 'Liu B, Liu Y, Qin Z, Zhou K, Xu H, He L, Li N, Su T, Sun J, Yue Z, Zang Z, Zhang W, Zhao J, Zhou Z, Liu L, Wu D, Wu J, Zhou J, Pang R, Wang Y, Liu J, Yu J, Liu Z. Electroacupuncture Versus Pelvic Floor Muscle Training Plus Solifenacin for Women With Mixed Urinary Incontinence: A Randomized Noninferiority Trial. Mayo Clin Proc. 2019 Jan;94(1):54-65. doi: 10.1016/j.mayocp.2018.07.021.'}, {'pmid': '25128002', 'type': 'DERIVED', 'citation': 'Liu B, Wang Y, Xu H, Chen Y, Wu J, Mo Q, Liu Z. Effect of electroacupuncture versus pelvic floor muscle training plus solifenacin for moderate and severe mixed urinary incontinence in women: a study protocol. BMC Complement Altern Med. 2014 Aug 15;14:301. doi: 10.1186/1472-6882-14-301.'}]}, 'descriptionModule': {'briefSummary': 'A noninferiority randomized controlled trial aimed at comparing the effect and safety of electroacupuncture versus the pelvic floor muscle training (PFMT) plus solifenacin for mixed urinary incontinence (MUI).', 'detailedDescription': "Participants experiencing mixed urinary incontinence will be recruited from 10 centers. A gynecologist or urologist will make the diagnosis. Central randomization will be performed by the Clinical Evaluation Center of the China Academy of Chinese Medical Sciences in Beijing.\n\nSample size: Sample size is based on the primary outcome. According to literature, the investigators predict that MUI patient's average 72-h incontinence episode frequency of the week 1-12 will decrease by 60% from the baseline after treatment of PFMT plus solifenacin. The number of the acupuncture group is 57%. For the assessment of noninferiority, 250 participants will be needed for each group allowing for a 15% dropout (α=0.05，β=0.2，δ=15%).\n\nQuality control: A 3-level monitoring system (monitors responsible for one center, monitors responsible for all centers and monitors responsible for the whole trial) will be established to check the performance of the trial in time. Outcome assessment, completion of case report forms and data management will be under strict supervision.\n\nData management: The Remote Dara Capture (RDC) system will be used for data entering. Both paper and electronic case report form will be reserved. A data verification plan is made."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* females meet the meet the diagnostic criteria of mixed urinary incontinence\n* aged 35-75 years\n* moderate and severe urinary incontinence with the urinary incontinence severity index between 3 and 9\n* suffering from urinary incontinence at least for 3 months with the 72-h incontinence episode frequency≥2 in the baseline assessment\n* voluntarily join the research and sign the informed consent\n\nExclusion Criteria:\n\n* pure stress urinary incontinence, pure urgency urinary incontinence, overflow incontinence and neurogenic bladder\n* medicine use for urinary incontinence or may affect the bladder function, or taking any non-drug therapy (such as electric stimulation, bladder training and pelvic floor muscle training) in the last month\n* symptomatic urinary tract infection and non-functional urologic disease\n* having ever undergone an operation for urinary incontinence or on the pelvic floor (including hysterectomy)\n* pelvic organ prolapse degree ≥2\n* residual urinary volume (RUV) \\>30 mL\n* maximum flow rate (Qmax) \\<20 mL/s;\n* be allergic to solifenacin or having contradictions for muscarine antagonist (such as urinary retention, gastric retention, myasthenia gravis, ulcerative colitis and angle closure glaucoma)\n* diseases affect function of lower urinary tract, such as uncontrolled diabetes, multiple sclerosis, Alzheimer's disease, Parkinson's disease, spinal injury, cauda equina injury and multiple system atrophy.\n* serious cardiovascular, pulmonary, cerebral, liver, kidney, hematopoietic system or psychiatric disease and cognitive impairment\n* patients with severe renal dysfunction or moderate hepatic dysfunction who are using strong Cyp3a4 Inhibitor like ketoconazole\n* unable or limited to walking, up and down stairs and running\n* poor compliance with electroacupuncture, pelvic floor muscle training or drug\n* pregnancy, lactation or within the 12 months after birth\n* having a cardiac pacemaker, a metal allergy, or a severe needle phobia.\n* volunteer of other trials"}, 'identificationModule': {'nctId': 'NCT02047032', 'briefTitle': 'Effect of Electroacupuncture Versus PFMT Plus Solifenacin for Mixed Urinary Incontinence', 'organization': {'class': 'OTHER', 'fullName': "Guang'anmen Hospital of China Academy of Chinese Medical Sciences"}, 'officialTitle': 'Effect of Electroacupuncture Versus PFMT Plus Solifenacin for Moderate and Severe Mixed Urinary Incontinence in Female: a Multicenter, Noninferiority, Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2012BAI24B01-MUI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'acupuncture', 'description': 'BL33 and BL35 of both sides are used. Every session will last for 30 minuets and will be given every other day. There are 36 sessions for each participant in all (3 session per week, 12 weeks).', 'interventionNames': ['Procedure: acupuncture']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Solifenacin plus PFMT', 'description': 'Both PFMT and solifenacin will be given for 36 weeks. Solifenacin will be taken 5mg once daily, before or after meal. PFMT includes intensive exercises conducted in hospital and home exercises. Intensive exercises will be done once every week for the first 12 weeks and once every four weeks for the 13th to 36th week. Home exercises will be done three times daily for 36 weeks.', 'interventionNames': ['Drug: solifenacin', 'Procedure: PFMT']}], 'interventions': [{'name': 'acupuncture', 'type': 'PROCEDURE', 'otherNames': ['electroacupuncture'], 'description': 'For BL33, the needle (75mm) will be inserted at the point upper and outside of BL33. Insert the needle with a 30-45°angle to a depth of 50-60 mm. The needle will be manipulated with an even lifting, thrusting and twisting method and the sense of soreness and distention will radiate to the perineal region or the anus. For BL35, the needle will be inserted upward and outward slightly with an even lifting, thrusting and twisting method. The sense of soreness and distention will radiate to the perineal region or the anus. The electric stimulator will be put on the two pair of points with a spare-dense wave, 10/50 Hz, 0.1-5.0 mA. The current intensity will be increased until the participant can not stand.', 'armGroupLabels': ['acupuncture']}, {'name': 'solifenacin', 'type': 'DRUG', 'otherNames': ['competitive cholinergic receptor antagonist'], 'description': 'Solifenacin used in this trial is produced by Astellas Pharma Europe B.V.(Country medicine accurate character No. J20090109 )', 'armGroupLabels': ['Solifenacin plus PFMT']}, {'name': 'PFMT', 'type': 'PROCEDURE', 'otherNames': ['pelvic floor muscle training'], 'description': 'Intensity of the PFMT exercises will conform to the guideline of National Institute for Health and Clinical Excellence (NICE).', 'armGroupLabels': ['Solifenacin plus PFMT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100053', 'city': 'Beijing', 'country': 'China', 'facility': "Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Zhishun Liu, doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': "Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Guang'anmen Hospital of China Academy of Chinese Medical Sciences", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Dean of Acupuncture Department of Guangan'men Hospital", 'investigatorFullName': 'Liu Zhishun', 'investigatorAffiliation': "Guang'anmen Hospital of China Academy of Chinese Medical Sciences"}}}}