Stress Urinary Incontinence (SUI)TVT/ULPNCT07484321
Long-term Outcomes of Urethral Ligament Plication and Transvaginal Tape Surgery
A study testing Transvaginal tape and Urethral ligament plication in people with Stress Urinary Incontinence (SUI), run by Sanliurfa Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Stress Urinary Incontinence (SUI)
- What is being tested?
- Transvaginal tape and Urethral ligament plication
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2025to 1 Aug 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being 18 years of age or older
- Presence of stress urinary incontinence symptoms
- Agreeing to undergo surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sanlıurfa Training and Research Hospital
Sanliurfa, İnönü Mahallesi, 61000
About this study
Official title: 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.
Read the 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.
- Conditions
- Stress Urinary Incontinence (SUI)
- Being tested
- Transvaginal tape, Urethral ligament plication
- Keywords
- sling, transvaginal tape, urethral ligament plication
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transvaginal tapeProcedure or surgery
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 plicationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Urethral ligament plication |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at first postoperative year
Secondary outcomes (1)
complications and adverse events
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
Measured: during postoperative first year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start1 Jun 2025
- Primary completion20 Jul 2026
- Study completion1 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stress Urinary Incontinence (SUI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanliurfa Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Alev Esercan, Sanliurfa Education and Research Hospital
- Investigators
- Peter Emmanuel Petros, DSc DS PhD MB BS MD FRCOG, Study director, Unaffiliated, retired
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07484321
- Sponsor's protocol ID
- SEAH-TVT/ULP
- Acronym
- TVT/ULP
- Status last verified
- Apr 2026
- First submitted
- 12 Mar 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be shared by doi .
Publications
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.
PubMed 2093278Esercan 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.
PubMed 40864278