Ignite Creation Date:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2025-12-27 @ 2:48 AM
Study NCT ID:
NCT05225168
Status:
COMPLETED
Last Update Posted:
2023-04-24
First Post:
2022-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Minisling Suburethral Sling and Laparoscopic Buch Colposuspension
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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-03-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-20', 'studyFirstSubmitDate': '2022-01-26', 'studyFirstSubmitQcDate': '2022-01-26', 'lastUpdatePostDateStruct': {'date': '2023-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'urinary stress test for evaluating objective cure', 'timeFrame': 'changes in urodynamics test at postoperative first and the 6th month', 'description': 'In the postoperative period, urodynamics test will be determined at the 6th month and the absence of incontinence will be considered a cure.'}], 'secondaryOutcomes': [{'measure': 'subjective continence', 'timeFrame': 'changes at postoperative first and the 6th month', 'description': 'Patient satisfaction will be investigated by keeping a urinary diary and questioning the quality of life.'}, {'measure': 'Prolapse quality of life (P-QoL) scale', 'timeFrame': 'changes at postoperative first and the 6th month', 'description': 'Patients will be evaluated with the prolapse quality of life (P-QoL) scale. In this scale, the questions are rated 1 to 4, and as the total score increases, the quality of life decreases.'}, {'measure': "King's Health Questionnaire", 'timeFrame': 'changes at postoperative first and the 6th month', 'description': "Patients will be evaluated with the King's Health Questionnaire"}, {'measure': 'Female sexual function scale (FSFI)', 'timeFrame': 'changes at postoperative first and the 6th month', 'description': 'Patients will be evaluated with the Female sexual function scale (FSFI). In this scale, the questions are rated 0 to 5, and if the total score increases, it means the sexual life is better. A minimum of 2 and a maximum of 36 points can be obtained from this test.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Genuine Stress Incontinence', 'minisling', 'laparoscopic burch'], 'conditions': ['Genuine Stress Incontinence']}, 'referencesModule': {'references': [{'pmid': '37888839', 'type': 'DERIVED', 'citation': 'Carter E, Johnson EE, Still M, Al-Assaf AS, Bryant A, Aluko P, Jeffery ST, Nambiar A. Single-incision sling operations for urinary incontinence in women. Cochrane Database Syst Rev. 2023 Oct 27;10(10):CD008709. doi: 10.1002/14651858.CD008709.pub4.'}]}, 'descriptionModule': {'briefSummary': 'When the studies in the literature including the mini-sling procedure and the laparoscopic buch colposuspension procedure are examined, it is seen that both methods are successful in the surgical treatment of stress urinary incontinence (SUI), but there is no study in which both procedures have been found to be superior to each other in terms of efficacy and safety. The aim of this study is to compare the minisling suburethral sling and laparoscopic buch colposuspension application in terms of efficacy and side effects in patients who will undergo surgical treatment due to genuine SUI.', 'detailedDescription': "When the studies in the literature including the mini-sling procedure and the laparoscopic buch colposuspension procedure are examined, it is seen that both methods are successful in the surgical treatment of stress urinery incontinence (SUI), but there is no study in which both procedures have been found to be superior to each other in terms of efficacy and safety. The aim of this study is to compare the minisling suburethral sling and laparoscopic buch colposuspension application in terms of efficacy and side effects in patients who will undergo surgical treatment due to genuine SUI. Investigators planned to measure patients' Kings Health Questionary and Prolapse Quality of Life test at first and 6 months after the surgery and to determine how the operation affects the quality of life."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. To be between the ages of 18-80\n2. Isolated genuine stress incontinence or accompanying pelvic organ prolapse\n3. Having accepted surgery for stress urinary incontinence -\n\nExclusion Criteria:\n\n* 1\\. Previously undergo pelvic organ prolapse surgery 2. Having a chronic lung disease such as asthma or Chronic obstructive pulmonary disease (COPD) 3. Having juvenile diabetes mellitus 4. History of gynecological cancer 5. Mesh allergy'}, 'identificationModule': {'nctId': 'NCT05225168', 'briefTitle': 'Comparison of Minisling Suburethral Sling and Laparoscopic Buch Colposuspension', 'organization': {'class': 'OTHER', 'fullName': 'Ataturk University'}, 'officialTitle': 'Comparison of Minisling Suburethral Sling Use and Laparoscopic Buch Colposuspension Application in Terms of Surgical Efficacy and Side Effects in True Stress Urinary Incontinence Surgery', 'orgStudyIdInfo': {'id': 'B.30.2.ATA.0.01.00/284'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'laparoscopic burch colposuspension group', 'description': 'this group will only have laparoscopic burch colposuspension', 'interventionNames': ['Procedure: laparoscopic burch colposuspension operation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Minisling Suburethral Sling group', 'description': 'this group will only have Minisling Suburethral Sling', 'interventionNames': ['Procedure: minisling suburethral sling']}], 'interventions': [{'name': 'laparoscopic burch colposuspension operation', 'type': 'PROCEDURE', 'otherNames': ['minisling suburethral sling'], 'description': 'By pushing the urethra medially, two sutures are placed on the bladder at trigon level and midurethral and suspended on the bilateral iliopectineal ligament and colposuspension is supplied.', 'armGroupLabels': ['laparoscopic burch colposuspension group']}, {'name': 'minisling suburethral sling', 'type': 'PROCEDURE', 'description': 'A vertical vaginal incision is made 1 cm below the external urethral meatus. It is followed by minimal vaginal dissection from the inferior portion of the ascending ramus of the ischiopubic bone to the obturator muscle. The arms of the mesh are fixed on both sides of the obturator internus muscle with the help of a trocar. After leaving a 1-2 mm gap between the mesh and the urethra, the vaginal wall is closed by suturing.', 'armGroupLabels': ['Minisling Suburethral Sling group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25100', 'city': 'Erzurum', 'country': 'Turkey (Türkiye)', 'facility': 'Gamze Nur Cimilli Senocak', 'geoPoint': {'lat': 39.90861, 'lon': 41.27694}}], 'overallOfficials': [{'name': 'Yakup Kumtepe', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ataturk University'}, {'name': 'Yakup Kumtepe', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ataturk University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ataturk University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant professor', 'investigatorFullName': 'Gamze Nur Cimilli Şenocak', 'investigatorAffiliation': 'Ataturk University'}}}}