Mini or Retropubic Sling in Women with Intrinsic Sphincter Deficiency at 12 Months-A Randomized Controlled Trial (Mini RISD).

Abstract

<h4>Introduction and hypothesis</h4>This study assesses the efficacy of the single-incision sling (SIS) versus the retropubic (RP) sling for women with urodynamic stress incontinence and intrinsic sphincter deficiency (ISD) - mini RISD.<h4>Methods</h4>This was a multicenter randomized trial of women with stress urinary incontinence (SUI) and ISD. The primary outcome was objective cure rate (negative clinical cough-stress test) at 6 and 12 months. The secondary outcomes were immediate and short-term complications and patient-reported outcomes at 6 and 12 months based on the International Consultation on Incontinence Urinary Incontinence Short Form, International Consultation on Incontinence Overactive Bladder, and Patient Global Impression of Improvement.<h4>Results</h4>Between 2016 and 2022, a total of 112 eligible women were randomized: 58 received an RP sling and 54 received an SIS. All 112 women (100%) had a 6-month follow-up, and 108 women (96%) completed a 12-month follow-up. At 12 months, there was no difference in the objective and subjective cure rates. 74% in the SIS and 69% in the RP group reported improvement as "very much better or much better" (relative risk 0.91 [95% CI 0.62-1.3], p = 0.63). There was no difference in the post-operative complications. However, one SIS was removed for groin pain associated with pre-pubic placement; a further 2 patients in the RP group and 1 in the SIS group had sling loosening and 1 in the SIS group had sling division. Overall repeat surgery was RP sling for 2 women with recurrent SUI and 1 mesh excision for exposure in the RP group. Five women had repeat continence surgery (4 RP sling and 1 fascial sling) in the SIS group.<h4>Conclusions</h4>For women with intrinsic sphincter deficiency, both RP slings and SIS had high success rates, with low complication rates at 12 months.