Burch Colposuspension and Mid-urethral Sling Operations
February 10, 2020 updated by: Pınar Kadirogulları, Kanuni Sultan Suleyman Training and Research Hospital
Comparison of Burch Colposuspension and Mid-urethral Sling Operations for Stress Urinary Incontinence
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Istanbul, Turkey, 33404
- Kanuni Sultan Suleyman Training and Research Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
A total laparoscopic hysterectomy was planned for benign causes, Patients who underwent simultaneous operation for incontinence
Description
Inclusion Criteria:
- A total laparoscopic hysterectomy was planned for benign causes,
- Patients scheduled for simultaneous operation for incontinence
Exclusion Criteria:
- Patients previously operated for urinary incontinence
- Patients whose diagnosis of stress urinary incontinence is uncertain
- Patients with urinary tract infection
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
laparoscopic burch colposuspension
who underwent total laparoscopic hysterectomy for benign causes and had simultaneous incontinence; patients undergoing laparoscopic burch colposuspension
|
total laparoscopic hysterectomy and simultaneous incontinence surgery with benign causes; Burch colposuspension and mid-urethral sling operations for stress urinary incontinence
|
|
mid urethral sling operations
who underwent total laparoscopic hysterectomy for benign causes and had simultaneous incontinence; patients undergoing mid-urethral sling operations
|
total laparoscopic hysterectomy and simultaneous incontinence surgery with benign causes; Burch colposuspension and mid-urethral sling operations for stress urinary incontinence
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
recurrence
Time Frame: 2 years
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 1, 2017
Primary Completion (ACTUAL)
January 1, 2019
Study Completion (ACTUAL)
January 1, 2020
Study Registration Dates
First Submitted
August 24, 2019
First Submitted That Met QC Criteria
August 24, 2019
First Posted (ACTUAL)
August 28, 2019
Study Record Updates
Last Update Posted (ACTUAL)
February 11, 2020
Last Update Submitted That Met QC Criteria
February 10, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 2018.02.02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.