Efficacy of Mini Sling Versus Transobturator Tape in Surgical Management of Women With Stress Urinary Incontinence

March 26, 2024 updated by: Tarek Salem Rezk, Ain Shams University
To compare the efficacy of mini sling against Transobturator tape for surgical management of women with stress urinary incontinence.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Urinary incontinence is defined as involuntary loss of urine and is divided into subtypes according to symptoms. These subtypes include SUI, in which urine loss occurs during exertion, physical exercise, coughing or sneezing; urgency urinary incontinence (UUI), in which urine loss is associated with urinary urgency; and mixed urinary incontinence (MUI), which is characterized by the association of stress loss with urgency.

There are non-surgical treatments (e.g., lifestyle modifications, pharmacotherapy, physiotherapy and vaginal pessary) and surgical treatments.

As regards sling use, it was found that mid urethral slings techniques achieved high cure rates in women with SUI and have become the mainstay for surgical treatment of SUI in women over the last 2 decades.

One of the modalities of such procedures is the transobturator mid urethral tape (TOT). It was introduced to minimize the complications of the previous retropubic tapes, which include injury to the bladder, major vessels, and bowel.

In an effort to maintain efficacy while eliminating some of the side effects, a new generation of tapes has been developed, called single incision tapes or mini-slings. They are designed to be shorter in length than standard mid-urethral slings and do not penetrate the tissues as deeply as standard slings.

Study Type

Interventional

Enrollment (Estimated)

42

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 Contact

Study Contact Backup

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

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Women with a medical history of SUI
  • mixed urinary incontinence (MUI) in which SUI had to be the dominating symptom
  • confirmed by a positive standardized cough test with 300 cm3 water in the bladder

Exclusion Criteria:

  • Women will be excluded if they are aged >60 years
  • had previous incontinence or pelvic organ prolapse surgery
  • planned or present pregnancy
  • residual urine volume>100 ml
  • previous pelvic irradiation
  • neurological conditions such as multiple sclerosis
  • current treatment with corticoids
  • history of genital or abdominal cancer or a pelvic mass.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: treatment of stress urinary incontinence by transobturator tape
patients with stress urinary incontinence are treated by transobturator tape
Procedure: transobturator tape
Women with stress urinary incontinence are treated by transobturator tape versus mini sling
Other Names:
  • mini sling
Other: treatment of stress urinary incontinence by mini sling
patients with stress urinary incontinence are treated by mini sling
Procedure: transobturator tape
Women with stress urinary incontinence are treated by transobturator tape versus mini sling
Other Names:
  • mini sling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparing Mini Sling and Transobturator Tape in Surgical Management of Women with Stress Urinary Incontinence regarding incidence of complications
Time Frame: one year

comparing between mini sling and transobturator tape in surgical management of women with stress urinary incontinence regarding:

• Urinary continence measured by ICIQ(international continence index questionnaire)
one year
Comparing Mini Sling and Transobturator Tape in Surgical Management of Women with Stress Urinary Incontinence regarding postoperative pain
Time Frame: one year

comparing between mini sling and transobturator tape in surgical management of women with stress urinary incontinence regarding:

• Post operative pain measured by NRS(numerical rating pain score)
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparing Mini Sling and Transobturator Tape in Surgical Management of Women with Stress Urinary Incontinence regarding sexual function
Time Frame: one year

comparing between mini sling and transobturator tape in surgical management of women with stress urinary incontinence regarding:

• Sexual function measured by FSFI(female sexual function index)
one year

Collaborators and Investigators

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

Sponsor

Ain Shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

April 1, 2024

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

March 12, 2024

First Submitted That Met QC Criteria

March 26, 2024

First Posted (Actual)

March 28, 2024

Study Record Updates

Last Update Posted (Actual)

March 28, 2024

Last Update Submitted That Met QC Criteria

March 26, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TOT versus mini sling

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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