Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT06232525 |
Other study ID # |
SEAH-63 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 2, 2024 |
Est. completion date |
February 2025 |
Study information
Verified date |
January 2024 |
Source |
Sanliurfa Education and Research Hospital |
Contact |
Alev Esercan, MD |
Phone |
+905052634609 |
Email |
alevesercan[@]gmail.com |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.