Ignite Creation Date:
2025-12-24 @ 3:43 PM
Ignite Modification Date:
2025-12-27 @ 7:06 AM
Study NCT ID:
NCT03695692
Status:
UNKNOWN
Last Update Posted:
2018-10-04
First Post:
2018-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Connective Tissue Massage in Women With Overactive Bladder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}], 'ancestors': [{'id': 'D001745', 'term': 'Urinary Bladder 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': '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': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-05-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2019-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-10-02', 'studyFirstSubmitDate': '2018-10-02', 'studyFirstSubmitQcDate': '2018-10-02', 'lastUpdatePostDateStruct': {'date': '2018-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overactive bladder symptoms measured by Overactive Bladder Questionnaire_V8', 'timeFrame': 'Change from baseline bladder symptoms at 6 weeks', 'description': 'Overactive Bladder Questionnaire\\_V8 assessing severity of overactive bladder symptoms will be used. This scale includes items on urgency, incontinence, nocturia and voiding frequency, as defined by the International Continence Society, referring to the previous four weeks. The final score is the sum of the partial scores obtained for each of the eight questions, ranging from 0 to 40. Patients with a final score of eight or more are considered as having Overactive Bladder symptoms.'}], 'secondaryOutcomes': [{'measure': "urgency complaint assessed with The patient's Perception of Intensity of Urgency Scale", 'timeFrame': 'Change from baseline urgency complaints at 6 weeks', 'description': "The patient's Perception of Intensity of Urgency Scale assessing urgency complaints will be used. This scale is scored on 0 and 4 points (the best score is '0' and the worst score is '4') based on urgency complaints. Higher scores indicate more severe urgency complaints."}, {'measure': "quality of life assessed with King's Health Questionnaire (KHQ)", 'timeFrame': 'Change from baseline quality of life at 6 weeks', 'description': "King's Health Questionnaire assessing quality of life related to urinary problems will be used. This questionnaire consists of two parts and 32 items. The first part (21 items) contains two single-item questions that address General Health Perception and Incontinence Impact and the following seven multi-item domains: Role, Physical, and Social Limitations, Limitations in Personal Relationship, Emotional Problems, Sleep and Energy Disturbances associated with UI, and Severity Measures for UI. The second part has an 11-item Symptom Severity Scale (SSS) that assesses the presence and severity of urinary symptoms. While the entire SSS is scored from 0 (best) to 30 (worst), the minimum possible score is 0 (best health) and the maximum possible score is 100 (worst health) for all other KHQ domains."}, {'measure': 'pelvic floor muscle strength measured with perineometer', 'timeFrame': 'Change from baseline pelvic floor muscle strength at 6 weeks', 'description': 'change in pelvic floor muscle strength as measued with perineometer'}, {'measure': 'diurnal urinary frequency, nocturia, maximum urinary volume, the number of urinary leakage and pad changes measured with voiding dairy', 'timeFrame': 'Change from baseline diurnal urinary frequency, nocturia, maximum urinary volume, the number of urinary leakage and pad changes at 6 weeks', 'description': 'Patients will be also instructed to keep voiding diary for three days. In this diary, diurnal urinary frequency, nocturia, maximum urinary volume, the number of urinary leakage and pad changes will be recorded.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Overactive Bladder']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to compare the effects of pelvic floor muscle trainig with connective tissue massage and only pelvic floor muscle training in women with overactive bladder'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 to 65 years of age,\n* having overactive bladder\n* being volunteer\n\nExclusion Criteria:\n\n* being in the period of pregnancy or breastfeeding,\n* having an accompanying neurological disease, presence of a mental issue that would prevent cooperation in examinations and/or implementations, history of acute infectionor presence of a malignce'}, 'identificationModule': {'nctId': 'NCT03695692', 'briefTitle': 'Effects of Connective Tissue Massage in Women With Overactive Bladder', 'organization': {'class': 'OTHER', 'fullName': 'Ataturk Training and Research Hospital'}, 'officialTitle': 'Assistant Professor, Physioterapist, PhD', 'orgStudyIdInfo': {'id': '2018/07-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Connective tissue massage group', 'description': 'Pelvic floor exercises and connective tissue massage have been applied', 'interventionNames': ['Behavioral: pelvic floor exercise and connective tissue massage']}, {'type': 'EXPERIMENTAL', 'label': 'Control group', 'description': 'Pelvic floor exercises alone have been applied', 'interventionNames': ['Behavioral: pelvic floor exercise']}], 'interventions': [{'name': 'pelvic floor exercise and connective tissue massage', 'type': 'BEHAVIORAL', 'description': 'Pelvic floor exercises with connective tissue massage will be performed.The massage program is carried out for 18 sessions, 3 days/week in 6 weeks. The exercise program is performed every day for 6 weeks', 'armGroupLabels': ['Connective tissue massage group']}, {'name': 'pelvic floor exercise', 'type': 'BEHAVIORAL', 'description': 'The exercise program is performed every day for 6 weeks', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Yasemin KARAASLAN', 'role': 'CONTACT', 'email': 'ptyasemindeveci@gmail.com', 'phone': '+90 535 845 96 25'}, {'name': 'Faruk Kucukdurmaz', 'role': 'CONTACT'}], 'facility': 'Ankara Yildirim Beyazit University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Seyda TOPRAK CELENAY', 'role': 'CONTACT', 'email': 'sydtoprak@hotmail.com', 'phone': '+90-534-041-3986'}, {'name': 'Yasemin KARAASLAN', 'role': 'CONTACT', 'email': 'ptyasemindeveci@gmail.com', 'phone': '+90 535 845 9625'}], 'overallOfficials': [{'name': 'Seyda TOPRAK CELENAY', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ankara Yildirim Beyazıt University'}, {'name': 'Yasemin Karaaslan', 'role': 'STUDY_CHAIR', 'affiliation': 'Beykent University'}, {'name': 'Faruk Kucukdurmaz', 'role': 'STUDY_CHAIR', 'affiliation': 'Kahramanmaras Sutcu Imam University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seyda TOPRAK CELENAY', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Seyda TOPRAK CELENAY', 'investigatorAffiliation': 'Ataturk Training and Research Hospital'}}}}