Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07484321

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

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

Age range

18 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sanlıurfa Training and Research Hospital

Sanliurfa, İnönü Mahallesi, 61000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

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.

    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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Sanliurfa Education and Research Hospital

Other Gov

Registry information

Official study title

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

Acronym: TVT/ULP

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 20, 2026
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.