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- Title
Mini or retropubic sling in women with Intrinsic Sphincter Deficiency -- an RCT (Mini RISD).
- Authors
Ow, L. L.; Lee, L.; Lim, Y. N.; Leitch, A.; Murray, C.; Dwyer, P.; Rosamilia, A.
- Abstract
Introduction: It remains unclear from medical literature whether the retropubic sling or the mini-sling has the best success rate with the least chance of complication for the treatment of stress urinary incontinence associated with intrinsic sphincter deficiency. While the retropubic sling has been shown to be superior to the obturator sling for the treatment of stress urinary incontinence associated with intrinsic sphincter deficiency1, the retropubic sling is associated with more complications such as bleeding, bladder injury and voiding difficulty2,3. The mini-sling, which is placed in a different way and is able to be placed under more tension than an obturator sling could be as effective as the retropubic sling but associated with less complication. We present our findings for our first 62 patients who were randomised. The objective was to examine if the mini-sling is as efficacious as the retropubic sling for women with urodynamic stress incontinence (SUI) and intrinsic sphincter deficiency (ISD) and compare their clinical outcomes. Materials and methods: This was a multicentre randomised controlled trial involving women with stress urinary incontinence associated with intrinsic sphincter deficiency. Exclusion criteria included untreated detrusor overactivity, significant voiding dysfunction, lower urinary tract anomaly (congenital), neurogenic bladder disorder, previous radiation therapy to pelvis, past history of any form of fistula involving the vagina, allergy to polypropylene or local anaesthetic. All women who were eligible for participation in this trial had their demographic data collected and underwent a standard POPQ examination. They were then randomised with equal probability to mini-sling or retropubic sling. If they needed a concomitant prolapse operation, they had this done. They were then reviewed at six weeks and then at six months for an uroflow, cough stress test and POPQ assessment. They also filled out standardised questionnaires at this visit. (ICIQ UI SF, ICIQ OAB, IIQ7, PGI-I, PISQ-12, EQ5D) and ICS POPQ assessment. An interim analysis was planned when 25% of the sample size reached the 6-month follow up. Primary outcome was to assess the objective cure rate (negative clinical cough stress test) of the mini-sling against the retropubic sling at six months post-surgery. Secondary outcomes included immediate and short term post-operative complications of the mini-sling against the retropubic sling, subjective outcomes using validated questionnaires, quality of life questionnaire and global assessment rating scale. Results: 62 women have been randomised and have completed a 6-month follow-up: 30 women randomised to mini-sling and 32 women to retropubic sling. Results were analysed by an intention-to-treat (ITT) analysis. No women crossed over groups. Table 1 shows the demographic data. Regarding our primary outcome (negative clinical cough stress test), there was no difference between the groups (mini-sling 4/30, 13% versus retropubic 3/32, 9.3%; p=0.71). Of the four women in the mini-sling group with SUI, two are awaiting repeat surgery, one received conservative treatment and one had the mini-sling removed due to pain. In the retropubic group, one had a repeat sling and two were conservatively treated. Complications in the retropubic groups included two requiring sling loosening. One had repeat SUI and a subsequent sling but still had SUI and one did not complain of any SUI. Complications in the mini-sling group included one participant who experienced groin pain on the left. She was initially conservatively treated with local anaesthetic/steroid injection but had the sling and anchor removed on the left side. The subjective symptoms of stress urinary incontinence were greater with the mini-sling but this did not reach statistical significance (mini-sling 11/30, 37% versus retropubic 6/32, 19%; p=0.16). ICIQ UISF and ICIQ-OAB scores were similarly improved in both groups as was the IIQ-7. Conclusions: At six months, the mini-sling is as efficacious as the retropubic sling in improving stress urinary incontinence based on the cough stress test. The planned interim analysis did not suggest a need to cease the study early due to safety or efficacy concerns.
- Subjects
ARTIFICIAL implants; MEDICAL cooperation; QUESTIONNAIRES; RESEARCH; STATISTICAL sampling; URINARY stress incontinence; TREATMENT of urinary stress incontinence; WOMEN'S health; RANDOMIZED controlled trials; TREATMENT effectiveness
- Publication
Australian & New Zealand Continence Journal, 2018, Vol 24, Issue 3, p83
- ISSN
1448-0131
- Publication type
Article