beta
Trial Radar AI
Clinical Trial NCT07484321 (TVT/ULP) for Stress Urinary Incontinence (SUI) is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
One study matched filter criteria
Card View
Back to Search

Long-term Outcomes of Urethral Ligament Plication and Transvaginal Tape Surgery (TVT/ULP) 200

Active, not recruiting
Clinical Trial NCT07484321 (TVT/ULP) is an interventional study for Stress Urinary Incontinence (SUI) that is active, not recruiting. It started on 1 June 2025 with plans to enroll 200 participants. Led by Sanliurfa Education and Research Hospital, it is expected to complete by 1 August 2026. The latest data from ClinicalTrials.gov was last updated on 20 March 2026.
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.
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...Show More
Official Title

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

Conditions
Stress Urinary Incontinence (SUI)
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • TVT/ULP
  • SEAH-TVT/ULP
NCT ID Number
NCT07484321
Start Date (Actual)
2025-06-01
Last Update Posted
2026-03-20
Completion Date (Estimated)
2026-08
Enrollment (Estimated)
200
Study Type
Interventional
PHASE
N/A
Status
Active, not recruiting
Keywords
sling
transvaginal tape
urethral ligament plication
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Quadruple
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Active Comparatorstress 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.
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 ComparatorStress 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.
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.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
the outcome measures of transvaginal tape (TVT) and urethral ligament plication (ULP) surgeries
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 MeasureMeasure DescriptionTime Frame
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
during postoperative first year
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Female
  1. Being 18 years of age or older
  2. Presence of stress urinary incontinence symptoms
  3. Agreeing to undergo surgery

  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
Sanliurfa Education and Research Hospital logoSanliurfa Education and Research Hospital
Study Responsible Party
Alev Esercan, Principal Investigator, Assoc. Prof., Sanliurfa Education and Research Hospital
No contact data.
1 Study Locations in 1 Countries

İnönü Mahallesi

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