BURCH Colposuspension or Transobturatuar Tape (TOT)

May 3, 2019 updated by: Pınar Kadirogulları, Kanuni Sultan Suleyman Training and Research Hospital

Which Anti-İncontinence Surgery Option is Better in Patients With Total Laparoscopic Hysterectomy? BURCH Colposuspension or Transobturatuar Tape (TOT)

Stress urinary incontinence surgery combined with hysterectomy can often be applied to patients in the same session. The aim of this study was to determine which urinary incontinence surgery would be a better option for patients who would have hysterectomy.

The aim of this study was to retrospectively review the data of 69 patients between the ages of 2014 and 2017 who underwent total laparoscopic hysterectomy and anti-incontinence surgery (TOT and Burch) for benign indications (uterine pathology) and stress urinary incontinence (SUI). In addition to demographic data and preoperative examination findings, operative times, postoperative hemogram values, postvoiding residual amounts and complications were examined.

In addition, FSI test results of women with sexual activity were compared with ICIQ-UI and UDI-6 interrogations related to urinary incontinence.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

69

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

40 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women between the ages of 40-65 who ; tlh operation with benign reasons and planned, and concurrent stress describing urinary incontinence.

Description

Inclusion Criteria:

  • tlh operation with benign reasons and planned,
  • concurrent stress describing urinary incontinence,
  • Women between the ages of 40-65

Exclusion Criteria:

  • planned operation with malignant causes,
  • urinary tract infection,
  • medication area for incontinence

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
TLH with BURCH Colposuspension
the patients who underwent simultaneous burch copying with TLH was evaluated. In addition to demographic data and preoperative examination findings, operative times, postoperative hemogram values, postvoiding residual amounts and complications were examined. In addition, FSI test results of women with sexual activity were compared with ICIQ-UI and UDI-6 interrogations related to urinary incontinence.
Procedure: BURCH Colposuspension
stress urinary incontinence surgery ( burch or tot)
TLH with Transobturatuar Tape (TOT)
In cases of simultaneous toting with TLH; In addition to demographic data and preoperative examination findings, operative times, postoperative hemogram values, postvoiding residual amounts and complications were examined. In addition, FSI test results of women with sexual activity were compared with ICIQ-UI and UDI-6 interrogations related to urinary incontinence.
Procedure: TOT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
operation time
Time Frame: 2 years
The duration of the procedure for stress urinary incontinence surgery was evaluated. recorded in minutes.
2 years
postoperative hemogram values
Time Frame: 2 years
postoperative hemogram values were evaluated. Recorded in g / dl.
2 years
postvoiding residues
Time Frame: 2 years
postvoiding residues were measured. Recorded in ml.
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, 2014

Primary Completion (ACTUAL)

January 1, 2017

Study Completion (ACTUAL)

January 1, 2017

Study Registration Dates

First Submitted

May 2, 2019

First Submitted That Met QC Criteria

May 2, 2019

First Posted (ACTUAL)

May 6, 2019

Study Record Updates

Last Update Posted (ACTUAL)

May 7, 2019

Last Update Submitted That Met QC Criteria

May 3, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2018.01.07

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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