Trial no.:
|
PACTR202310537535826 |
Date of Approval:
|
05/10/2023 |
Trial Status:
|
Retrospective registration - This trial was registered after enrolment of the first participant |
|
TRIAL DESCRIPTION |
Public title
|
The use of MUS in the correction of low-grade cystoceles: A prospective randomized trial |
Official scientific title |
Midurethral sling versus combined mid-urethral sling and anterior colporrhaphy in the treatment of stress urinary incontinence with anterior pelvic organ prolapse, a randomized controlled trial |
Brief summary describing the background
and objectives of the trial
|
Aim of the study: The standard treatment of stress incontinence (SUI) in women is a mid-urethral sling and stress incontinence affects around 30 % of women above the age of 45 years. Noteworthy, about 40% of them had also concomitant cystocele. It was noted that a mid- urethral sling (MUS) can cure a cystocele if done under certain circumstances. MUS with anterior colporrhaphy (AC) as a treatment for (SUI) with cystocele is more invasive and carries greater risk than MUS alone. Whether MUS can improve both SUI and cystoceles is yet to prove and that is why we conducted this study
Patients and Methods: This is a prospective randomized study involving women with grade 1 or 2 cystocele and SUI, > 21 years of age and had no previous surgery for SUI. Predominant SUI, symptomatic anterior POP, and informed consent were mandatory. Patients were randomized as to whether AC was performed. The sling procedure was left to the surgeon’s discretion: pubovaginal fascial sling (PVS), tension-free vaginal tape (TVT), or trans-obturator tape (TOT). Success was defined as negative stress test and no evidence of cystocele upon local examination.
Results:
Ninety-eight patients were enrolled, 48 underwent MUS, and 50 underwent MUS and AC. Mean age was 44.96 ± 8.13 years. Baseline characteristics were similar. Operative time and blood loss were significantly higher in the MUS/AC group (P= 0.01 and 0.02, respectively). At 3 months, success was 79.1% and 77.8% in the MUS and MUS/AC groups, respectively. This was maintained until 6 months (79.1% and 77.8%, respectively). At 1 year, the results were comparable with success rates of 96.2% and 87.0% in the MUS and MUS and AC, respectively. Symptom scores were comparable at 6- and 12-month evaluations.
Conclusion:
MUS correct symptomatic grade 1 or 2 cystoceles without need for anterior colporrhaphy, which carries the risk of a significantly longer procedure and more significant blood los |
Type of trial |
RCT |
Acronym (If the trial has an acronym then please provide) |
|
Disease(s) or condition(s) being studied |
Urological and Genital Diseases |
Sub-Disease(s) or condition(s) being studied |
|
Purpose of the trial |
Treatment: Surgery |
Anticipated trial start date |
15/07/2020 |
Actual trial start date |
15/07/2020 |
Anticipated date of last follow up |
31/08/2021 |
Actual Last follow-up date |
30/09/2021 |
Anticipated target sample size (number of participants) |
116 |
Actual target sample size (number of participants) |
98 |
Recruitment status |
Completed |
Publication URL |
|
|