Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
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
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table from a statistics book Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Anterior colporrhaphy time of surgery is expected to be around 60 minutes and follow up is 1 year Anterior colporrhaphy was performed using 3 sutures of 2-zero ‎polydioxanone, approximating the pubocervical fascia in the midline.‎ 50 Active-Treatment of Control Group
Experimental Group Mid urethral sling only 0 Surgery takes 60 minutes on average and the follow up is 1 year A mid-urethral sling, whether autologous (rectus fascia) or synthetic ( Tension fee vaginal tape or transobturator tape) is used for correction of incontinence and anterior organ prolapse 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Female patients Above 21 years Stress incontinence is the main complaint Associated low-grade anterior POP The associated urethra of bladder pathology Previous pelvic surgery within 6 months Unwilling to provide an informed consent Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 21 Year(s) 65 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 26/12/2013 Urology department Board
Ethics Committee Address
Street address City Postal code Country
Gomhorria st Mansoura 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Correction of anterior pelvic organ prolapse POP 3- 6- and 12 months
Secondary Outcome Cure of stress incontinence 3- 6 and 12 months
Secondary Outcome Adverse events 3- 6- and 12 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Urology and Nephrology Center Mansoura University Gomhorria st Mansoura 35516 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Institutional Gomhorria Mansoura 35516 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Urology and Nephrology Center Gomhorria st Mansoura 35516 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Bassem Wadie bassem_wadie@mans.edu.eg 20502160817 Gomhorria
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Professor of urology
Role Name Email Phone Street address
Public Enquiries Mervat Sheta UNC@mans.edu.eg 20502202222 Gomhorria
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Chief librarian
Role Name Email Phone Street address
Scientific Enquiries Ahmed Osman medsecunc@gmail.com 20502202257 Gomhorria st
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Head of urology dept.
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes IPD are available in the attached Excel file. All collected participant data is included in the file underlying the results of this article after de-identification Study protocol is also available on request Data are available immediately after publication and for 5 years afterwards Data are should be available for investigators whos proposal is reviewed by an independent review committee To achieve aims of the approved proposal Proposals should be directed to bassem_wadie@mans.edu.eg for 5 years starting from publication of the study Statistical Analysis Plan,Study Protocol 5 years The principal investigator is the one who controls access to data as well as data analysis
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 08/09/2023
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 18/09/2023 Result - 21/09/2023
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information