Short-Term Outcomes of TOT, TVT, and Burch Surgery Assessed by Transperineal Ultrasound

January 5, 2026 updated by: gizem boz izceyhan, Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Comparison of Anatomical and Subjective Short-term Outcomes of TOT, TVT, and Burch Colposuspension: A Randomized Controlled Trial Using Transperineal Ultrasound

Stress urinary incontinence is a common condition in women and is often treated with surgical procedures such as transobturator tape (TOT), tension-free vaginal tape (TVT), and Burch colposuspension. Although these procedures are widely used, there is limited information comparing their short-term anatomical and patient-reported outcomes using imaging techniques.

The aim of this study is to compare the short-term anatomical and subjective outcomes of TOT, TVT, and Burch colposuspension in women with stress urinary incontinence. Transperineal ultrasonography will be used to assess anatomical changes before surgery and during follow-up. Patient-reported outcomes and clinical findings will also be evaluated.

The results of this study may help improve the understanding of surgical outcomes in stress urinary incontinence and support clinical decision-making.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

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 (Türkiye)
      • Istanbul, Turkey (Türkiye)
        • Zeynep Kamil Women and Children Diseases 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Female patients aged 18 years or older
  • Diagnosis of stress urinary incontinence based on clinical evaluation
  • Candidates for surgical treatment with transobturator tape (TOT), tension-free vaginal tape (TVT), or Burch colposuspension
  • Ability to provide written informed consent
  • Willingness to participate in the study and comply with follow-up visits

Exclusion Criteria:

  • Mixed or urge-predominant urinary incontinence
  • Previous anti-incontinence or pelvic floor surgery
  • Neurogenic bladder disorders
  • Active urinary tract infection at the time of evaluation
  • Pregnancy or planned pregnancy during the study period
  • Known pelvic malignancy
  • Inability to undergo transperineal ultrasonographic evaluation

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: tot
Participants underwent mid-urethral sling surgery for the treatment of stress urinary incontinence.
Procedure: Transobturator Tape (TOT) Procedure
Placement of a synthetic tape beneath the mid-urethra via the transobturator route.
Other Names:
  • tot
Active Comparator: tvt
Participants in this arm underwent tension-free vaginal tape (TVT) surgery for the treatment of stress urinary incontinence.
Procedure: Tension-Free Vaginal Tape (TVT) Procedure
Placement of a synthetic tape beneath the mid-urethra using a retropubic approach.
Active Comparator: Burch Colposuspension
Participants in this arm underwent Burch colposuspension surgery for the treatment of stress urinary incontinence.
Procedure: Burch Colposuspension Procedure
Suspension of the anterior vaginal wall to the iliopectineal (Cooper's) ligament using non-absorbable sutures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Urethrovesical and Urethral Angles Assessed by Transperineal Ultrasound
Time Frame: Baseline (preoperative) and 3 months postoperatively
The primary outcome is the change in urethrovesical and urethral angles measured by transperineal ultrasonography before surgery and at 3 months after surgery.
Baseline (preoperative) and 3 months postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective Improvement in Stress Urinary Incontinence Symptoms
Time Frame: Baseline and 3 months postoperatively
Subjective outcomes were assessed using the Urogenital Distress Inventory-Short Form (UDI-6) and the Incontinence Impact Questionnaire-Short Form (IIQ-7). For both scales, scores range from 0 to 100, where higher scores indicate a greater impact of symptoms and worse quality of life.
Baseline and 3 months postoperatively

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of Anatomical Outcomes Between Surgical Techniques
Time Frame: 3 months postoperatively
Anatomical outcomes assessed by transperineal ultrasonography were compared between the TOT, TVT, and Burch colposuspension groups.
3 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zeynep Kamil Maternity and Pediatric Research and Training 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)

April 1, 2023

Primary Completion (Actual)

April 1, 2025

Study Completion (Actual)

April 1, 2025

Study Registration Dates

First Submitted

December 16, 2025

First Submitted That Met QC Criteria

December 16, 2025

First Posted (Estimated)

December 31, 2025

Study Record Updates

Last Update Posted (Actual)

January 8, 2026

Last Update Submitted That Met QC Criteria

January 5, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 37/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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