Ignite Creation Date:
2025-12-24 @ 11:47 PM
Ignite Modification Date:
2026-01-05 @ 6:32 PM
Study NCT ID:
NCT03394651
Status:
UNKNOWN
Last Update Posted:
2018-11-14
First Post:
2017-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prostatic Obstruction Investigation Team Multicenter Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'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': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-12-19', 'size': 169849, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2017-12-19T02:24', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'blood and urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 11500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2022-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-11-11', 'studyFirstSubmitDate': '2017-12-14', 'studyFirstSubmitQcDate': '2018-01-08', 'lastUpdatePostDateStruct': {'date': '2018-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The changes of IPSS scores between baseline and follow-up', 'timeFrame': 'Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided, or 1, 6, 18, 24 months after surgery.', 'description': 'Measured using standard IPSS scoring system'}, {'measure': 'The changes of nocturia symptoms between baseline and follow-up', 'timeFrame': 'Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided, or 1, 6, 18, 24 months after surgery', 'description': 'Measured using standard ICIQ-N-QoL score'}, {'measure': 'The changes of erectile function between baseline and follow-up', 'timeFrame': 'Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided, or 1, 6, 18, 24 months after surgery', 'description': 'Measured using standard IIEF score'}, {'measure': 'The changes of maximum flow rate (ml/s) between baseline and follow-up', 'timeFrame': 'Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided or 1, 6, 18, 24 months after surgery', 'description': 'Maximum flow rate will be measured using urinary flow study'}, {'measure': 'The changes of post void residual volume (ml) between baseline and follow-up', 'timeFrame': 'Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided or 1, 6, 18, 24 months after surgery', 'description': 'post void residual volume (ml) will be measured using urinary flow study'}, {'measure': 'The changes of detrusor pressure at maximum flow rate (cmH2O) between baseline and follow-up', 'timeFrame': 'Measured at baseline (if surgical treatment is required) and 1, 6, 18, 24 months after surgery', 'description': 'It will be measured using pressure-flow study'}, {'measure': 'The changes of prostate volume (ml) between baseline and follow-up', 'timeFrame': 'Measured at baseline and 6, 12, 18, 24, 36 months after oral medication treatment', 'description': 'Prostate volume (ml) will be measured using transrectal prostate ultrasound and calculated as: prostate volume (ml) = length (mm) \\* width (mm) \\* height (mm) \\* 0.52'}, {'measure': 'The changes of intravesical prostate protrusion (mm) between baseline and follow-up', 'timeFrame': 'Measured at baseline and 6, 12, 18, 24, 36 months after oral medication treatment', 'description': 'Intravesical prostate protrusion (mm) will be measured using transrectal prostate ultrasound and calculated as the distance between the tip of the prostate median lobe and bladder neck'}], 'secondaryOutcomes': [{'measure': 'The changes of Blood pressure between baseline and follow-up', 'timeFrame': 'Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided or 1, 6, 18, 24 months after surgery.', 'description': 'systolic pressure/ diastolic pressure in mmHg.'}, {'measure': 'The changes of Blood lipid between baseline and follow-up', 'timeFrame': 'Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided or 1, 6, 18, 24 months after surgery.', 'description': 'The blood lipid level will be assessed using multiple serum parameters, namely, cholesterol (mmol/L), triglyceride (mmol/L), high-density lipoprotein (mmol/L), low-density lipoprotein (mmol/L), lipoprotein-a (mmol/L)'}, {'measure': 'The changes of Blood glucose between baseline and follow-up', 'timeFrame': 'Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided or 1, 6, 18, 24 months after surgery.', 'description': 'The blood glucose level will be assessed using multiple serum parameters, namely, fast blood-glucose (mmol/L), glycosylated hemoglobin (%), glycated albumin (%)'}, {'measure': 'The changes of Kidney function between baseline and follow-up', 'timeFrame': 'Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided or 1, 6, 18, 24 months after surgery.', 'description': 'The kidney function will be assessed using multiple serum and urine parameters, namely, serum creatinine (μmoI/L), cystatin-C (mg/L), eGRF (calculated via both CKD-EPI equation and MDRD equation), BUN (mmol/L), uric acid (μmoI/L), β2-MG (mg/L), NAG (U/L), Na (mmol/L), K (mmol/L), the degree of urine protein'}, {'measure': 'The changes of PSA (ng/ml) between baseline and follow-up', 'timeFrame': 'Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided or 1, 6, 18, 24 months after surgery.', 'description': 'Serum PSA level will be measured to rule out prostate cancer'}, {'measure': 'The changes of RBC (/HP) between baseline and follow-up', 'timeFrame': 'Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided or 1, 6, 18, 24 months after surgery.', 'description': 'Urine RBC will be measured to detect the incidence of urinary tract infection or tumor'}, {'measure': 'The changes of WBC (/HP) between baseline and follow-up', 'timeFrame': 'Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided or 1, 6, 18, 24 months after surgery.', 'description': 'Urine WBC will be measured to detect the incidence of urinary tract infection'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['male', 'lower urinary tract symptoms', 'comorbidities', 'chronic kidney diseases', 'urodynamics', 'medical therapy', 'surgical treatment'], 'conditions': ['Lower Urinary Tract Symptoms']}, 'referencesModule': {'references': [{'pmid': '31562145', 'type': 'DERIVED', 'citation': 'Song QX, Zhang Y, Ye X, Xue W, Xu C, Xu J, Abrams P, Sun Y; Prostatic Obstruction Investigation Team (POInT). Current status and progression of lower urinary tract symptoms in Chinese male patients: the protocol and rationale for a nationwide, hospital-based, prospective, multicentre study. BMJ Open. 2019 Sep 27;9(9):e028378. doi: 10.1136/bmjopen-2018-028378.'}]}, 'descriptionModule': {'briefSummary': 'The present is a multicenter, observational study organized by the Prostatic Obstruction Investigation Team (POInT), with a main purpose of looking into the current status and symptom progression of male lower urinary tract symptoms patients in China.', 'detailedDescription': "Lower urinary tract symptoms (LUTS) is a common medical condition negatively affecting people's quality of life worldwide. LUTS may be caused by structural or functional abnormalities in 1 or more parts of the lower urinary tract, including bladder, prostate, internal and external urethral sphincter and distal urethra. Furthermore, evidence exists to demonstrate that LUTS is associate with lifestyle factors, systemic comorbidities and geriatric diseases, such as smoking, obesity, metabolic syndrome, chronic kidney diseases and chronic obstructive pulmonary disease etc. So far, there is lack of evidence to illustrate the symptom features and comorbidities among Chinese male LUTS patients. Therefore, this multicenter clinical study aims to investigate the present status and symptom progression among male LUTS patients in China."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Chinese male, 45 year or elder, presenting lower urinary tract symptoms.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male, 45 years or older.\n2. The presence of lower urinary tract symptoms, i.e. frequency, urgency, urge incontinence, dysuria, post-micturition dribble, etc.\n3. All participants have signed the informed consent form.\n4. Clinical data comes from 23 selected hospitals spread across China.\n\nExclusion Criteria:\n\n1. Lower urinary tract symptoms as a result of urethral stricture, stone diseases, chronic prostatitis, space-occupying lesions etc.\n2. Diagnosis or suspicion of renal, ureteral, bladder, prostate, urethral or pelvic tumor.\n3. Known neurogenic or congenital lower urinary tract dysfunction.\n4. Known urinary tract, prostate or pelvic surgical history.\n5. Existence of anatomical abnormalities of the urinary tract (e.g. diverticulum of the bladder or urethra, ectopic ureteral orifice etc.).\n6. The presence of acute conditions, such as, urinary tract infection, fever, heart failure etc.\n7. Patients with poor compliance or cognitive competence.'}, 'identificationModule': {'nctId': 'NCT03394651', 'acronym': 'POInT', 'briefTitle': 'Prostatic Obstruction Investigation Team Multicenter Study', 'organization': {'class': 'OTHER', 'fullName': 'Changhai Hospital'}, 'officialTitle': 'The Current Status and Progression of Symptoms and Comorbidities Among Male Lower Urinary Tract Symptoms Patients in China: a Multicenter Study From Prostatic Obstruction Investigation Team (POInT)', 'orgStudyIdInfo': {'id': 'POINT-2017'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Oral medication group', 'description': 'Patients in this group will receive oral medications to treat lower urinary tract symptoms', 'interventionNames': ['Drug: Oral medications to treat lower urinary tract symptoms']}, {'label': 'Surgical treatment group', 'description': 'Patients in this group receive minimal invasive transurethral prostate procedures.', 'interventionNames': ['Procedure: Minimal invasive transurethral prostate procedures']}], 'interventions': [{'name': 'Oral medications to treat lower urinary tract symptoms', 'type': 'DRUG', 'description': "Patients in this group will receive oral medication(s) depending on doctors' prescriptions.", 'armGroupLabels': ['Oral medication group']}, {'name': 'Minimal invasive transurethral prostate procedures', 'type': 'PROCEDURE', 'description': 'Patients in this group will receive surgical treatment.', 'armGroupLabels': ['Surgical treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200433', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qi-Xiang Song, MD', 'role': 'CONTACT', 'email': 'rex_song918@qq.com', 'phone': '8615021223013'}], 'facility': 'Changhai Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Qi-Xiang Song, MD, PhD', 'role': 'CONTACT', 'email': 'rex_song918@qq.com', 'phone': '086-15021223013'}, {'name': 'Wei Xue, MD, PhD', 'role': 'CONTACT', 'email': 'uroxuewei@163.com', 'phone': '086-13801931604'}], 'overallOfficials': [{'name': 'Yinghao Sun, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Changhai Hospital'}, {'name': 'Wei Xue, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'RenJi Hospital'}, {'name': 'Qi-Xiang Song, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Changhai Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changhai Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beijing Hospital', 'class': 'OTHER_GOV'}, {'name': 'Zhongda Hospital', 'class': 'OTHER'}, {'name': 'RenJi Hospital', 'class': 'OTHER'}, {'name': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University', 'class': 'OTHER'}, {'name': 'The Second Hospital of Nanjing Medical University', 'class': 'OTHER'}, {'name': 'Shanghai Changzheng Hospital', 'class': 'OTHER'}, {'name': 'Third Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, {'name': 'First Affiliated Hospital of Suzhou Medical College', 'class': 'OTHER'}, {'name': 'Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, {'name': 'Zhujiang Hospital', 'class': 'OTHER'}, {'name': 'Zhejiang University', 'class': 'OTHER'}, {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, {'name': 'Xinqiao Hospital of Chongqing', 'class': 'OTHER'}, {'name': "Zhejiang Provincial People's Hospital", 'class': 'OTHER'}, {'name': 'Huashan Hospital', 'class': 'OTHER'}, {'name': 'Southwest Hospital, China', 'class': 'OTHER'}, {'name': 'First Affiliated Hospital of Fujian Medical University', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Beijing University', 'class': 'UNKNOWN'}, {'name': 'Daping Hospital and the Research Institute of Surgery of the Third Military Medical University', 'class': 'OTHER'}, {'name': 'Tianjin Medical University Second Hospital', 'class': 'OTHER'}, {'name': 'The Third Affiliated Hospital of Beijing University', 'class': 'UNKNOWN'}, {'name': "Jiangsu Provincial People's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yinghao Sun', 'investigatorAffiliation': 'Changhai Hospital'}}}}