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NCT Number: NCT07312617

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

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Key information

Conditions

Stress Urinary Incontinence in Women Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Pelvic Floor Disorders Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Zeynep Kamil Women and Children Diseases Training and Research Hospital

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transobturator Tape (TOT) Procedure

Procedure

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

Other names: tot

Tension-Free Vaginal Tape (TVT) Procedure

Procedure

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

Burch Colposuspension Procedure

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 31, 2025
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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