Long-term Outcomes of Urethral Ligament Plication and Transvaginal Tape Surgery

NCT07484321 | Active Not Recruiting

• 1 other identifier: SEAH-TVT/ULP
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stress Urinary Incontinence (SUI)

Keywords

sling; transvaginal tape; urethral ligament plication

Outcome Measures

Primary Outcomes (1)

• 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.

  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 Outcomes (1)

• complications and adverse events

  during postoperative first year

Study Arms (2)

stress urinary incontinence treated by transvaginal tape

ACTIVE COMPARATOR

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

Stress urinary incontinence treated with urethral ligament plication

ACTIVE COMPARATOR

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

Interventions

Transvaginal tape PROCEDURE

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.

stress urinary incontinence treated by transvaginal tape

Urethral ligament plication PROCEDURE

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.

Stress urinary incontinence treated with urethral ligament plication

Eligibility Criteria

• Age: 18 Years - 90 Years
• Gender Eligibility Details: Treatment of female stress urinary incontinence is studied.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being 18 years of age or older
• Presence of stress urinary incontinence symptoms
• Agreeing to undergo surgery

You may not qualify if:

• Pregnancy
• Being under 18 years of age
• Suspicion of malignancy
• History of previous mid-urethral sling or urinary incontinence surgery
• Urinary incontinence due to neurological bladder

Sponsors & Collaborators

• Sanliurfa Education and Research Hospital: lead

Study Sites (1)

Sanlıurfa Training and Research Hospital

Sanliurfa, İnönü Mahallesi, 61000, Turkey (Türkiye)

Location

Related Publications (2)

• Petros PE, Ulmsten UI. An integral theory of female urinary incontinence. Experimental and clinical considerations. Acta Obstet Gynecol Scand Suppl. 1990;153:7-31. doi: 10.1111/j.1600-0412.1990.tb08027.x.

  PMID: 2093278 BACKGROUND

• Esercan A, Sivaslioglu AA, Petros P. A Randomized Comparison of Transobturator Tape with the Plication of Urethral Ligaments in the Treatment of Stress Urinary Incontinence. Int Urogynecol J. 2025 Dec;36(12):2507-2515. doi: 10.1007/s00192-025-06193-z. Epub 2025 Aug 27.

  PMID: 40864278 BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Peter Emmanuel Petros, DSc DS PhD MB BS MD FRCOG

  Unaffiliated, retired

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: March 12, 2026
• First Posted: March 20, 2026
• Study Start: June 1, 2025
• Primary Completion: July 1, 2026
• Study Completion: August 1, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: August 2026-September 2026

Locations

TU (1)