Ignite Creation Date:
2025-12-24 @ 7:46 PM
Ignite Modification Date:
2025-12-28 @ 12:39 PM
Study NCT ID:
NCT06376903
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-22
First Post:
2024-04-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Pilates Exercises on Stress Urinary Incontinence in Posmenopausal Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014550', 'term': 'Urinary Incontinence, Stress'}], 'ancestors': [{'id': 'D014549', 'term': 'Urinary Incontinence'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-04-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-09-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-17', 'studyFirstSubmitDate': '2024-04-17', 'studyFirstSubmitQcDate': '2024-04-17', 'lastUpdatePostDateStruct': {'date': '2024-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '• Revised urinary incontinence scale', 'timeFrame': '6 weeks', 'description': ': It is considered one of the tools which used to diagnose SUI. It takes the five best items which loaded on the urinary leakage. The items comprising this revised scale include urine leakage related to the feeling of urgency, urine leakage related to physical activity, coughing or sneezing, small amounts of urine leakage \\[drops\\]) as well as two items related to frequency and amount of incontinence Scoring is by simple summation and the range of the total score is between zero and 12(0= no incontinence , 1-2= slight incontinence , 3-6= moderate incontinence , 7-9= severe incontinence , 12= very severe incontinence)'}], 'secondaryOutcomes': [{'measure': '• Quality of Life Questionnaire (QOL) for stress urinary incontinence', 'timeFrame': '6 weeks', 'description': ": it has been developed to provide detailed information on how urinary incontinence affects patients' lives. It is a valid and reliable instrument for assessing QOL in women with voiding symptoms, including urinary incontinence. It includes questions that evaluate the distress and impact of urinary incontinence in three domains: avoidance and limiting behavior, social embarrassment and psychosocial impact"}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Urinary Stress Incontinence']}, 'descriptionModule': {'briefSummary': '• This study will be conducted to determine the effect of pilates exercises on stress urinary incontinence in postmenopausal women', 'detailedDescription': 'Pilates exercises help in the controlled movement of the core, that act as a corset and it activates both core muscle and synergistically the PFM. (Trantafylidis, 2009).\n\nThere is limited evidence regarding the use of Pilates exercises for the management of stress urinary incontinence (SUI) in older women (Keri, 2013; Pyria et al, 2021). So this study will be conducted to determine the effect of Pilates exercises on SUI in postmenopausal women which provide an insight about the benefits of such exercise on postmenopausal SUI.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '50 Years', 'genderBased': True, 'genderDescription': '* Postmenopausal women (at least 12months after menstrual cessation), diagnosed with SUI by the gynecologist.\n* Their ages will range from 50-60 years old .', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:Postmenopausal women (at least 12months after menstrual cessation), diagnosed with SUI by the gynecologist.\n\n* Their ages will range from 50-60 years old .\n* Their BMI will be less than 30kg/m2 .\n* All of them suffer from mild to moderate degree of SUI .\n* All of them delivered vaginally.\n* All are multipara with 2 or more children.\n* All are of sedentary life style.\n\nExclusion Criteria:Women will be excluded from the study if they have:\n\n* Previous bladder surgery.\n* Post pelvic radiotherapy.\n* Vaginal/abdominal hysterectomy.\n* Vaginal infection.\n* Severe urinary tract infection.\n* Uterine Prolapse'}, 'identificationModule': {'nctId': 'NCT06376903', 'briefTitle': 'Effect of Pilates Exercises on Stress Urinary Incontinence in Posmenopausal Women', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Pilates Exercises on Stress Urinary Incontinence in Posmenopausal Women', 'orgStudyIdInfo': {'id': 'P.T.REC/012/004860'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Study group ; of pilates exercises,Kegel exercises,and home care advices.advices', 'description': '•study group : It will be consisted of thirty postmenopausal women suffering from mild and moderate stress urinary incontinence, will perform program of pilates exercises, 3 sessions/week (30 minutes a session ) for 12 weeks in addition to Kegel exercises (15min/three times per week/ for 12 weeks) and home care advices.', 'interventionNames': ['Other: Pilates exercise - pelvic floor exercise - home advices']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Controlled group;Kegel exercises,and home care advices.', 'description': 'Controlled group : It will be consisted of thirty postmenopausal women suffering from mild and moderate stress urinary incontinence, will perform kegel exercises (15min/three times per week/ for 12 weeks) and home care advices as in group (A).', 'interventionNames': ['Other: Pilates exercise - pelvic floor exercise - home advices']}], 'interventions': [{'name': 'Pilates exercise - pelvic floor exercise - home advices', 'type': 'OTHER', 'otherNames': ['Pelvic floor exercise - home care advices'], 'description': 'Group (A) (Study group): It will be consisted of thirty postmenopausal women suffering from mild and moderate stress urinary incontinence, will perform program of pilates exercises, 3 sessions/week (30 minutes a session ) for 12 weeks in addition to Kegel exercises (15min/three times per week/ for 12 weeks) and home care advices.\n\n• Group (B) (Controlled group): It will be consisted of thirty postmenopausal women suffering from mild and moderate stress urinary incontinence, will perform kegel exercises (15min/three times per week/ for 12 weeks) and home care advices as in group (A).', 'armGroupLabels': ['Controlled group;Kegel exercises,and home care advices.', 'Study group ; of pilates exercises,Kegel exercises,and home care advices.advices']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'MANAL AHMED EL-SHAFEI, PHD', 'role': 'CONTACT', 'email': 'Manalpt1989@gmail.com', 'phone': '+201220664518', 'phoneExt': '+201220664518'}, {'name': 'AZZA BARAMOUD kASSAB, PHD', 'role': 'CONTACT', 'email': 'drazzakassab@yahoo.com', 'phone': '+201008410312'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Cairo university', 'investigatorFullName': 'Eslam Mohmedy Mosa', 'investigatorAffiliation': 'Cairo University'}}}}