Ignite Creation Date:
2025-12-24 @ 1:38 PM
Ignite Modification Date:
2026-01-02 @ 11:52 AM
Study NCT ID:
NCT05474495
Status:
COMPLETED
Last Update Posted:
2022-12-15
First Post:
2022-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transversus Abdominis and Pelvic Floor Muscle Strengthening Exercise Program In Patients With Grade 1 Cystocele
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014549', 'term': 'Urinary Incontinence'}, {'id': 'D011391', 'term': 'Prolapse'}, {'id': 'D052858', 'term': 'Cystocele'}], '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': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D056887', 'term': 'Pelvic Organ Prolapse'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-08-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-13', 'studyFirstSubmitDate': '2022-07-24', 'studyFirstSubmitQcDate': '2022-07-24', 'lastUpdatePostDateStruct': {'date': '2022-12-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pelvic Floor Disability Index', 'timeFrame': '6 Weeks', 'description': 'The Pelvic Floor Disability index Questionnaire is a condensed version of the Pelvic Floor Distress Inventory (PFDI).The PFDI-20 has 20 items and 3 scales of your symptoms. All items use the following format with a response scale from 0 to 4. Scale Scores: Obtain the mean value of all of the answered items within the corresponding scale (possible value 0 to 4) and then multiply by 25 to obtain the scale score (range 0 to 100).'}, {'measure': 'Pelvic organ prolapse quantification (POP-Q)', 'timeFrame': '6 Weeks', 'description': 'It will be used for diagnostic purpose for prolapse and participants will only be considered as Grade 1 Cystocele on the basis of this tool. and it will also used to compare the Exercise effects on prolapse at the start and at the end of study. It uses objective and precise distance measurements to the reference point, the hymen. Cystocele and prolapse of the vagina from other causes is staged using POP-Q criteria and can range from good support (no descent into the vagina) reported as a POP-Q stage 0 or I to a POP-Q score of IV, which includes prolapse beyond the hymen. It also used to quantify the movement of other structures into the vaginal lumen and their descent.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cystocele', 'Disability', 'Pelvic Floor Prolapse', 'Urinary Incontinence'], 'conditions': ['Disability Physical', 'Urinary Incontinence', 'Prolapse']}, 'referencesModule': {'references': [{'pmid': '30614646', 'type': 'BACKGROUND', 'citation': 'Muro S, Tsukada Y, Harada M, Ito M, Akita K. Anatomy of the smooth muscle structure in the female anorectal anterior wall: convergence and anterior extension of the internal anal sphincter and longitudinal muscle. Colorectal Dis. 2019 Apr;21(4):472-480. doi: 10.1111/codi.14549. Epub 2019 Jan 24.'}, {'pmid': '34575049', 'type': 'BACKGROUND', 'citation': 'Roch M, Gaudreault N, Cyr MP, Venne G, Bureau NJ, Morin M. The Female Pelvic Floor Fascia Anatomy: A Systematic Search and Review. Life (Basel). 2021 Aug 30;11(9):900. doi: 10.3390/life11090900.'}, {'pmid': '31555847', 'type': 'BACKGROUND', 'citation': 'Flusberg M, Kobi M, Bahrami S, Glanc P, Palmer S, Chernyak V, Kanmaniraja D, El Sayed RF. Multimodality imaging of pelvic floor anatomy. Abdom Radiol (NY). 2021 Apr;46(4):1302-1311. doi: 10.1007/s00261-019-02235-5.'}, {'pmid': '35333406', 'type': 'BACKGROUND', 'citation': 'Stupart D, Pickles K, Briggs C. Anatomy of the vesicovaginal fascia and its relation to branches of the inferior hypogastric plexus. Clin Anat. 2022 Oct;35(7):855-860. doi: 10.1002/ca.23858. Epub 2022 Apr 2.'}, {'pmid': '30140597', 'type': 'BACKGROUND', 'citation': 'Eid S, Iwanaga J, Oskouian RJ, Loukas M, Tubbs RS. Comprehensive Review of the Cardinal Ligament. Cureus. 2018 Jun 20;10(6):e2846. doi: 10.7759/cureus.2846.'}]}, 'descriptionModule': {'briefSummary': 'Cystocele, a protrusion of the bladder, happens while the bladder descends into the vagina. There are more than one underlying causes for the development of cystocele ensuing in weak point of the muscles and the connective tissue surrounding the bladder and vagina.\n\nThis study will be a randomized clinical trial. After the department permission of physical therapy data will be collected from patient of Jinnah Hospital. Data will be collected before and after treatment. Randomization will be done by lottery method. Group A will be given pelvic floor strengthning exercises and goup B will be given transverse abdominas strengthning exercises. Each group will have 33 patients each. A 6-week physical therapy program will be planned. Group A will be given pelvic floor muscle strengthning exercise and the group B will given transverse abdominas exercises.Data will be entered and analysed by SPSS version 25.', 'detailedDescription': "Cystocele, in any other case called a protrusion of the bladder, happens while the bladder descends into the vagina.The bladder bulges via the anterior wall of the vagina, with which it's miles anatomically related. There are more than one underlying causes for the development of cystocele ensuing in weak point of the muscles and the connective tissue surrounding the bladder and vagina. This study will be a randomized clinical trial. After the department permission of physical therapy data will be collected from patient of Jinnah Hospital. Data will be collected before and after treatment. Total sample size is 60. Non probability convenient sampling technique will be used. Randomization will be done by lottery method. Group A will be given pelvic floor strengthning exercises and goup B will be given transverse abdominas strengthning exercises. Each group will have 33 patients each. A 6-week physical therapy program will be planned. Group A will be given pelvic floor muscle strengthning exercise and the group B will given transverse abdominas exercises. Individual sessions will be held twice a week for 60 minutes each. Each meeting will include a theoretical portion of up to 10 minutes and a practical portion of roughly 50 minutes. Home plan will also be shared with them. Post treatment analysis will be done in order to find the effects of both regims. Data will be entered and analysed by SPSS version 25. The aim is to compare the effects of transversus abdominis and pelvic floor muscle strengthening exercise program on disability and urinary incontinence in patients with grade 1 cystocele."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '35 Years', 'genderBased': True, 'genderDescription': 'Females With Grade 1 Cystocele', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Females age of 35 to 65 years will be included in our study.\n* Females who will not able to contract the Pelvic floor muscles\n* Female who hill have mixed urinary incontinence will be included in our study\n\nExclusion Criteria:\n\n* Females with malignancies will be excluded\n* Females with neurological issue will be excluded\n* Females who hill have untreated urinary tract infection will be excluded from our study'}, 'identificationModule': {'nctId': 'NCT05474495', 'briefTitle': 'Transversus Abdominis and Pelvic Floor Muscle Strengthening Exercise Program In Patients With Grade 1 Cystocele', 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': 'Comparative Effects of Transversus Abdominis and Pelvic Floor Muscle Strengthening Exercise Program on Disability and Urinary Incontinence In Patients With Grade 1 Cystocele', 'orgStudyIdInfo': {'id': 'REC/RCR & AHS/22/0533'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pelvic floor muscle training', 'description': 'Experimental Group (Group A) will receive pelvic floor muscle training. Two sessions a week for 6 weeks, each session lasting 45 mins.', 'interventionNames': ['Other: Pelvic floor muscle training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Transverse abdominas strength training', 'description': 'Active Comparator (Group B) will receive transverse abdominas strength training. Treatment will be given 5 days a week and continued for 6 weeks.', 'interventionNames': ['Other: Transverse abdominas strength training']}], 'interventions': [{'name': 'Pelvic floor muscle training', 'type': 'OTHER', 'description': 'Pelvic floor muscle training. Two sessions a week for 6 weeks, each session lasting 45 mins.', 'armGroupLabels': ['Pelvic floor muscle training']}, {'name': 'Transverse abdominas strength training', 'type': 'OTHER', 'description': 'Transverse abdominas strength training will be given 5 days a week and continued for 6 weeks.', 'armGroupLabels': ['Transverse abdominas strength training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Jinnah Hospital,', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'overallOfficials': [{'name': 'Sabiha Arshad, M.Phil', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riphah International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riphah International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}