Clinical trial NCT06232525: A Randomized Comparison of Transobturator Tape With the Plication of Urethral Ligaments in the Treatment of Stress Urinary Incontinence
Official title: A Randomized Comparison of Transobturator Tape With the Plication of Urethral Ligaments in the Treatment of Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Incontinence, Female
Keywords: transobturator tape
urethral ligament plication
Lead sponsor: Sanliurfa Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2024-01-30
Enrollment: 108
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In the double-blind study, one group of patients with stress urinary incontinence will undergo transobturator tape surgery and the other group of patients will undergo urethral ligament plication surgery.
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare the efficacy of transobturator tape (TOT) operation and urethral ligament plication operation in stress incontinence patients. The main question:

* Which operation is more effective in treatment of stress incontinence?
* Which operation has less complication and risks? Participants will be followed about 5 days, 2.5 months, 6 months and 1 year after the operation and asked about the continence status and complications.

Detailed description: The study will be a double-blind, prospective experimental study. When examining patients with stress urinary incontinence complaints, POP-Q staging in terms of pelvic organ prolapse before surgery, symptom interrogation in the examination of the anterior/middle and posterior compartments based on the Integral Theory in the pelvic floor examination, Urogenital Distress Inventory (UDI-6) for the evaluation of urinary incontinence and Female sexual function scale (FSFI) scales will be filled in to evaluate sexual functions. One group of patients will undergo transobturator tape (TOT), and the other group will undergo urethral ligament plication surgery.

Patients who are decided to have surgery due to stress urinary incontinence will undergo TOT surgery and urethral plication surgery, without being told which surgery they will have (both surgeries will be performed with the mid-urethral approach and the patient will not be told whether mesh is used or not), with a draw system in which the computer program will decide on the surgeon who will perform the surgery. The surgeon will always be the same person (Esercan A), and on the morning of the surgery, he will be told about the surgery he will perform and will be asked not to share it with the patient.

At the end of the 5th day, 2.5 months, 6 months and 1 year after the surgery, the patients were called for control and examined by the same doctor, different from the doctors who wrote the surgery and the publication. POP-Q staging was performed again in terms of pelvic organ prolapse, based on the Integral Theory in the pelvic floor examination. During the examination of the anterior/middle and posterior compartments, symptom inquiry, Urogenital Distress Inventory (UDI-6) for the evaluation of urinary incontinence and Female Sexual Function Scale (FSFI) scales will be filled in for the evaluation of sexual functions. The FSFI survey has 19 questions; It evaluates 6 main factors: sexual desire, sexual arousal, lubrication, orgasm, satisfaction and pain/discomfort. The highest total raw score that can be obtained in this scale is 95, the lowest raw score is 4, and after multiplying the coefficients, the highest score is 36 and the lowest score is 2. Impact coefficients used to score the entire scale; It was determined as 0.6 for sexual desire, 0.3 for sexual arousal and lubrication, and 0.4 for orgasm, satisfaction and pain/discomfort. A FSFI score below 26.55 is defined as compatible with sexual dysfunction. Additionally, if there are any complications, they will be recorded in detail.

Eligibility criteria: Inclusion Criteria:

1. Being 18 years or older
2. Presence of stress urinary incontinence symptoms
3. Agreeing to have 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. Being diagnosed with intrinsic sphincter (urethral) insufficiency
6. Urinary incontinence due to neurological bladder

Primary outcomes:
measure: Subjective finding of no urinary incontinence
timeFrame: After the first day of the operation day and all of the follow-up (postoperative 5th day, 2.5 th month, 6th month and first year)
measure: Objective finding of no urinary incontinence
timeFrame: After the first day of the operation day and all of the follow-up(postoperative 5th day, 2.5 th month, 6th month and first year)
Secondary outcomes:
measure: complications
timeFrame: postoperative 5th day, 2.5 th month, 6th month and first year
Other outcomes:
Locations:
city: Şanlıurfa
country: Turkey
facility: Sanliurfa Education and Research Hospital
Study officials:
affiliation: retired
name: Peter Emanuel Petros, Prof.
role: STUDY_DIRECTOR
affiliation: Sanliurfa Education and Research Hospital
name: Alev Esercan, MD
role: PRINCIPAL_INVESTIGATOR
References: