Long-term Outcomes of Urethral Ligament Plication and Transvaginal Tape Surgery (TVT/ULP)

April 26, 2026 updated by: Alev Esercan, Sanliurfa Education and Research Hospital

Long-term Outcomes of Urethral Ligament Plication (ULP) and Trans-vaginal Tape (TVT) Surgery: a Multi-center Study.

In the treatment of urinary incontinence caused by coughing, sneezing, or heavy lifting, the investigators will perform urinary tract tightening surgery, both with and without a sling, to address the relaxed urinary tract. The investigators would like to evaluate the one-year success and results of the sling or non-sling urinary tract tightening surgery the investigators will perform on the participants.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The participants will undergo surgery to tighten the urinary tract due to urinary incontinence. There are two types of surgery: with and without a sling. Both have a high success rate. However, in rare cases, complications related to the sling method can occur in some patients. The urinary incontinence will be prevented with either the sling or non-sling method. The investigators will call the participants for follow-up appointments after the surgery to share the results with them.

Study Type

Interventional

Enrollment (Estimated)

200

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 Locations

  • Turkey (Türkiye)
    • İnönü Mahallesi
      • Sanliurfa, İnönü Mahallesi, Turkey (Türkiye), 61000
        • Sanlıurfa Training and Research Hospital

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Being 18 years of age or older
  2. Presence of stress urinary incontinence symptoms
  3. Agreeing to undergo surgery

Exclusion Criteria:

  1. Pregnancy
  2. Being under 18 years of age
  3. Suspicion of malignancy
  4. History of previous mid-urethral sling or urinary incontinence surgery
  5. Urinary incontinence due to neurological bladder

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: stress urinary incontinence treated by transvaginal tape
Patients with stress urinary incontinence will be randomised and at this arm, treated by transvaginal tape and evaluated at first year of the surgery.
Procedure: Transvaginal tape

Method: The procedure uses a, usually polypropylene, mesh tape placed under the mid-urethra to reinforce the pelvic muscles.

Approach: It involves a small vaginal incision and two small abdominal incisions to pull the tape through, which is then adjusted for proper tension.
Active Comparator: Stress urinary incontinence treated with urethral ligament plication
Patients with stress urinary incontinence will be randomised and at this arm, treated by urethral ligament plication and evaluated at first year of the surgery.
Procedure: Urethral ligament plication
By vaginal route, plication of the four attachments of pubourethral ligament (PUL) as retropubic part of PUL, midurethral part of PUL, external urethral ligament and pubococygeous muscle with 2-0 polyester suture.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the outcome measures of transvaginal tape (TVT) and urethral ligament plication (ULP) surgeries: number of participants that have negatif cough test and subjective continence status.
Time Frame: at first postoperative year
the continence status at one-year of TVT and ULP surgeries by cough stress test and subjective complaint about stress urinary incontinence
at first postoperative year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
complications and adverse events
Time Frame: during postoperative first year

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0".

During first postoperative year, the complications; like mesh erosion, suture reaction, bleeding, need for suture removal, need for mesh removal, urinary retention, bladder injury, bowel injury
during postoperative first year

Collaborators and Investigators

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

Sponsor

Sanliurfa Education and Research Hospital

Investigators

  • Study Director: Peter Emmanuel Petros, DSc DS PhD MB BS MD FRCOG, Unaffiliated, retired

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 (Actual)

June 1, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

March 12, 2026

First Submitted That Met QC Criteria

March 16, 2026

First Posted (Actual)

March 20, 2026

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 26, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SEAH-TVT/ULP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data will be shared by doi .

IPD Sharing Time Frame

August 2026-September 2026

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

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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