Burch Colposuspension and Mid-urethral Sling Operations
Comparison of Burch Colposuspension and Mid-urethral Sling Operations for Stress Urinary Incontinence
1 other identifier
observational
50
1 country
1
Brief Summary
Stress urinary incontinence is common in women. the treatment of this condition is surgery. investigators add stress incontinence surgery to patients who undergo total laparoscopic hysterectomy for benign reasons. Depending on the patient's general condition and indications, the operation can be performed by vaginal approach, as well as mid-urethral sling operations and laparoscopic burch colposuspension. The researchers aimed to compare these two types of operations performed on patients. In this way, the superiority and disadvantage of each other in two procedures will be demonstrated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2019
CompletedFirst Submitted
Initial submission to the registry
August 24, 2019
CompletedFirst Posted
Study publicly available on registry
August 28, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2020
CompletedFebruary 11, 2020
February 1, 2020
2 years
August 24, 2019
February 10, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
recurrence
in patients who underwent total laparoscopic hysterectomy and simultaneous incontinence surgery for benign reasons; In the early postoperative period, relapse will be evaluated at 1 month, 6 months and 12 months.
2 years
Study Arms (2)
laparoscopic burch colposuspension
who underwent total laparoscopic hysterectomy for benign causes and had simultaneous incontinence; patients undergoing laparoscopic burch colposuspension
mid urethral sling operations
who underwent total laparoscopic hysterectomy for benign causes and had simultaneous incontinence; patients undergoing mid-urethral sling operations
Interventions
total laparoscopic hysterectomy and simultaneous incontinence surgery with benign causes; Burch colposuspension and mid-urethral sling operations for stress urinary incontinence
Eligibility Criteria
A total laparoscopic hysterectomy was planned for benign causes, Patients who underwent simultaneous operation for incontinence
You may qualify if:
- A total laparoscopic hysterectomy was planned for benign causes,
- Patients scheduled for simultaneous operation for incontinence
You may not qualify if:
- Patients previously operated for urinary incontinence
- Patients whose diagnosis of stress urinary incontinence is uncertain
- Patients with urinary tract infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kanuni Sultan Süleyman Training and Research Hospital
Istanbul, 33404, Turkey (Türkiye)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- pınar kadiroğulları M.D, Department of Obstetrics and Gynecology
Study Record Dates
First Submitted
August 24, 2019
First Posted
August 28, 2019
Study Start
January 1, 2017
Primary Completion
January 1, 2019
Study Completion
January 1, 2020
Last Updated
February 11, 2020
Record last verified: 2020-02