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

NCT07312617 | Completed

• 1 other identifier: 37/2023
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stress Urinary Incontinence in Women; Pelvic Floor Disorders

Keywords

sui; tpus

Outcome Measures

Primary Outcomes (1)

• Change in Urethrovesical and Urethral Angles Assessed by Transperineal Ultrasound

  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 Outcomes (1)

• Subjective Improvement in Stress Urinary Incontinence Symptoms

  Baseline and 3 months postoperatively

Other Outcomes (1)

• Comparison of Anatomical Outcomes Between Surgical Techniques

  3 months postoperatively

Study Arms (3)

tot

ACTIVE COMPARATOR

Participants underwent mid-urethral sling surgery for the treatment of stress urinary incontinence.

Procedure: Transobturator Tape (TOT) Procedure

tvt

ACTIVE COMPARATOR

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

Burch Colposuspension

ACTIVE COMPARATOR

Participants in this arm underwent Burch colposuspension surgery for the treatment of stress urinary incontinence.

Procedure: Burch Colposuspension Procedure

Interventions

Transobturator Tape (TOT) Procedure PROCEDURE

Placement of a synthetic tape beneath the mid-urethra via the transobturator route.

Also known as: tot

tot

Tension-Free Vaginal Tape (TVT) Procedure PROCEDURE

Placement of a synthetic tape beneath the mid-urethra using a retropubic approach.

tvt

Burch Colposuspension Procedure PROCEDURE

Suspension of the anterior vaginal wall to the iliopectineal (Cooper's) ligament using non-absorbable sutures.

Burch Colposuspension

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zeynep Kamil Maternity and Pediatric Research and Training Hospital: lead

Study Sites (1)

Zeynep Kamil Women and Children Diseases Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pelvic Floor Disorders

Interventions

Suburethral Slings

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Model Details: Participants were assigned to one of three parallel intervention groups (TOT, TVT, or Burch colposuspension), and each participant received only one type of surgical intervention. Outcomes were assessed and compared between groups during the same follow-up period.

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: December 31, 2025
• Study Start: April 1, 2023
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: January 8, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)