Ignite Creation Date:
2024-05-06 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06232525
Status:
RECRUITING
Last Update Posted:
2024-01-30
First Post:
2024-01-12
Brief Title:
A Randomized Comparison of Transobturator Tape With the Plication of Urethral Ligaments in the Treatment of Stress Urinary Incontinence
Sponsor:
Alev Esercan
Organization:
Sanliurfa Education and Research Hospital
Study Overview
Official Title:
A Randomized Comparison of Transobturator Tape With the Plication of Urethral Ligaments in the Treatment of Stress Urinary Incontinence
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
added
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 25 months 6 months and 1 year after the operation and asked about the continence status and complications
Which operation is more effective in treatment of stress incontinence
Which operation has less complication and risks Participants will be followed about 5 days 25 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 anteriormiddle 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 25 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 anteriormiddle 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 paindiscomfort 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 06 for sexual desire 03 for sexual arousal and lubrication and 04 for orgasm satisfaction and paindiscomfort A FSFI score below 2655 is defined as compatible with sexual dysfunction Additionally if there are any complications they will be recorded in detail
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 25 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 anteriormiddle 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 paindiscomfort 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 06 for sexual desire 03 for sexual arousal and lubrication and 04 for orgasm satisfaction and paindiscomfort A FSFI score below 2655 is defined as compatible with sexual dysfunction Additionally if there are any complications they will be recorded in detail
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None