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

NCT ID: NCT07312617

Last Updated: 2026-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2025-04-01

Brief Summary

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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.

Detailed Description

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Conditions

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Stress Urinary Incontinence in Women Pelvic Floor Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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tot

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

Group Type ACTIVE_COMPARATOR

Transobturator Tape (TOT) Procedure

Intervention Type PROCEDURE

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

tvt

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

Group Type ACTIVE_COMPARATOR

Tension-Free Vaginal Tape (TVT) Procedure

Intervention Type PROCEDURE

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

Burch Colposuspension

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

Group Type ACTIVE_COMPARATOR

Burch Colposuspension Procedure

Intervention Type PROCEDURE

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

Interventions

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Transobturator Tape (TOT) Procedure

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

Intervention Type PROCEDURE

Tension-Free Vaginal Tape (TVT) Procedure

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

Intervention Type PROCEDURE

Burch Colposuspension Procedure

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

Intervention Type PROCEDURE

Other Intervention Names

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tot

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Zeynep Kamil Maternity and Pediatric Research and Training Hospital

OTHER

Sponsor Role lead

Responsible Party

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gizem boz izceyhan

doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Zeynep Kamil Women and Children Diseases Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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37/2023

Identifier Type: -

Identifier Source: org_study_id

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