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

Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Status: Completed

Conditions: Pelvic Floor Disorders; Stress Urinary Incontinence in Women

Treatments: Procedure: Tension-Free Vaginal Tape (TVT) Procedure; Procedure: Transobturator Tape (TOT) Procedure; Procedure: Burch Colposuspension Procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT07312617

37/2023

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 3 patient groups

tot

Active Comparator group

Description:

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

Treatment:

Procedure: Transobturator Tape (TOT) Procedure

tvt

Active Comparator group

Description:

Participants in this arm underwent tension-free vaginal tape (TVT) surgery for the treatment of stress urinary incontinence.

Treatment:

Procedure: Tension-Free Vaginal Tape (TVT) Procedure

Burch Colposuspension

Active Comparator group

Description:

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

Treatment:

Procedure: Burch Colposuspension Procedure