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

  • Turkey
      • 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
Procedure: total laparoscopic hysterectomy and simultaneous incontinence surgery with benign causes
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
Procedure: total laparoscopic hysterectomy and simultaneous incontinence surgery with benign causes
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.

Sponsor

Kanuni Sultan Suleyman Training and Research Hospital

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.

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