Ignite Creation Date:
2025-12-25 @ 12:28 AM
Ignite Modification Date:
2026-01-05 @ 5:14 PM
Study NCT ID:
NCT04159467
Status:
UNKNOWN
Last Update Posted:
2022-10-04
First Post:
2019-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Pelvic Floor Muscle Training on Urinary Incontinence Reports in Obese Women Undergoing a Low Calorie Diet
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014549', 'term': 'Urinary Incontinence'}, {'id': 'D009765', 'term': 'Obesity'}], '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'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The principal investigator will be blind in relation to group allocation and the outcome assessor will be blind too in relation to group allocation'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2023-12-26', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-03', 'studyFirstSubmitDate': '2019-10-21', 'studyFirstSubmitQcDate': '2019-11-07', 'lastUpdatePostDateStruct': {'date': '2022-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self report of urinary incontinence by women', 'timeFrame': 'Women will be evaluated at baseline', 'description': 'Self report of urinary incontinence measured using question 3 of the ICIQ-SF. Women will be considered incontinent if they choose option 1,2,3,4,5 of question 3. Women will be considered continent if they choose option 0 of question 3.'}, {'measure': 'Severity and impact of Urinary incontinence in women´s quality of life', 'timeFrame': 'Women will be evaluated at baseline', 'description': 'the severity and impact of Urinary incontinence in women´s quality of life will be measured using the ICIQ-SF score'}], 'secondaryOutcomes': [{'measure': "Participants' adherence to the PFMT protocol", 'timeFrame': 'Women will be evaluated at baseline and right after 12 weeks', 'description': 'Will be assessed using an exercise diary and the complier average causal effects (CACE) method'}, {'measure': 'PFM function', 'timeFrame': 'Women will be evaluated at baseline', 'description': 'the modified Oxford grading scale- MOS (digital vaginal palpation)'}, {'measure': 'participants self-perception of their PFM function', 'timeFrame': 'Women will be evaluated at baseline', 'description': 'women´s self-perception of their PFM function according to the MOS categories'}, {'measure': 'Satisfaction with treatment', 'timeFrame': 'only after 12 weeks from the baseline assessment', 'description': 'Analogic visual scale where 0 represents no satisfaction with treatment and 10 the maximum satisfaction'}, {'measure': 'Subjective satisfaction with treatment', 'timeFrame': 'only after 12 weeks from the baseline assessment', 'description': 'Women will answer the following questions: are you satisfied with the treatment you received for UI? would you do this treatment again ? would you recomend this treatment ? to other people, would you chase another treatment ?'}, {'measure': 'Identification of barriers for the treatment', 'timeFrame': 'only after 12 weeks from the baseline assessment', 'description': 'Women will answer the following questions: Do identifie any barrier or difficulty to adhere to the treatment you received for urinary incontinence?'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Urinary Incontinence', 'Obesity', 'Diet', 'Pelvic floor muscles training'], 'conditions': ['Urinary Incontinence', 'Obesity', 'Strength; Pelvic Floor']}, 'referencesModule': {'references': [{'pmid': '37277833', 'type': 'DERIVED', 'citation': 'Mendes PCS, Fretta TB, Camargo MFC, Driusso P, Homsi Jorge C. Effect of pelvic floor muscle training on reports of urinary incontinence in obese women undergoing a low-calorie diet before bariatric surgery - protocol of a randomized controlled trial. Trials. 2023 Jun 5;24(1):376. doi: 10.1186/s13063-023-07347-4.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the efficacy of pelvic floor muscle training (PFMT) on urinary incontinence reports in obese women undergoing a low calorie diet prior to bariatric surgery for obesity. The study will also assess and compare rates of adherence to treatments, pelvic floor muscle function and women´s self perception of their PFM function, and satisfaction with treatment.', 'detailedDescription': 'According to the World Health Organization (WHO), the adult overweight rate in 2014 reached 20%, with the highest prevalence among women. In addition to metabolic diseases, obesity can cause musculoskeletal disorders, including pelvic floor muscle (PFM) disorders and urinary incontinence (UI) is the most prevalent one. Conservative intervention can be medication, lifestyle changes, but pelvic floor muscle training (PFMT) is considered the first-line conservative therapy for urinary incontinence in women and it is effective when delivered both individually or in group.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of the outpatient bariatric surgery service that will start a low calorie diet program as part of the bariatric presurgery routine of the service\n* Women\n* Over 18 years old\n* With body mass index greater than 30kg / m2\n* Who have reported urinary incontinence in the last four weeks\n* Who have the ability to contract the pelvic floor muscles\n* No report of neurological disease, no cognitive impairment\n* That are not pregnant.\n\nExclusion Criteria:\n\n* Women who do not wish to continue participating in the research.'}, 'identificationModule': {'nctId': 'NCT04159467', 'briefTitle': 'Effect of Pelvic Floor Muscle Training on Urinary Incontinence Reports in Obese Women Undergoing a Low Calorie Diet', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Effect of Pelvic Floor Muscle Training on Urinary Incontinence Reports in Obese Women Undergoing a Low Calorie Diet Prior to Bariatric Surgery: an Assessor Blinded Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '16379919.5.0000.5440'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1- diet therapy (control)', 'description': 'Control group undergoing a low calorie diet will not receive supervised pelvic floor muscle training. This group will be assessed at baseline and after 12 weeks. For ethics reason at the end of the study women of the control group will be invited to receive the pelvic floor muscle training program. However, this will not be part of the study.', 'interventionNames': ['Other: Pelvic Floor Muscle Training']}, {'type': 'EXPERIMENTAL', 'label': 'Grupo 2 - low calorie diet + PFMT (experimental)', 'description': 'The experimental group will receive supervised pelvic floor muscle training in addition to a hypocaloric diet. Women will be instructed to perform daily pelvic floor muscle training at home. 4 sets of 10 maximal voluntary pelvic floor contractions sustained for 6 seconds, followed by 5 voluntary contractions of the pelvic floor muscles. The 4 sets will be performed in 2 different positions (sitting and standing). Once a month, they will receive a supervised in-person session using the same protocol described above, in the other weeks of the month will receive a session supervised by telephysiotherapy once a week. In addition to supervised sessions, women will be encouraged to perform the protocol three more days a week. In addition, they will be instructed to perform "the knack" maneuver.', 'interventionNames': ['Other: Pelvic Floor Muscle Training']}], 'interventions': [{'name': 'Pelvic Floor Muscle Training', 'type': 'OTHER', 'description': '4 sets of 10 maximal perceived voluntary pelvic floor contractions sustained for 6 seconds, followed by 5 voluntary pelvic floor muscle contractions. The supervised 4 sets will be performed in 2 different positions (sitting and standing).', 'armGroupLabels': ['Group 1- diet therapy (control)', 'Grupo 2 - low calorie diet + PFMT (experimental)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14408060', 'city': 'Franca', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Pauliana Mendes', 'role': 'CONTACT', 'email': 'doutorapaulianasouza@outlook.com', 'phone': '16993649581'}], 'facility': 'Pauliana Carolina de Souza Mendes', 'geoPoint': {'lat': -20.53861, 'lon': -47.40083}}], 'centralContacts': [{'name': 'Pauliana CS Mendes', 'role': 'CONTACT', 'email': 'doutorapaulianasouza@outlook.com', 'phone': '+55 16 99364-9581'}, {'name': 'Cristine HJ Ferreira', 'role': 'CONTACT', 'email': 'cristine@fmrp.usp.br', 'phone': '+55 16 99621-7919'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physiotherapist', 'investigatorFullName': 'Pauliana Carolina de Souza Mendes', 'investigatorAffiliation': 'University of Sao Paulo'}}}}