What is the best indication for single-incision Ophira Mini Sling? Insights from a 2-year follow-up international multicentric study

Abstract

Introduction and hypothesisThe Ophira Mini Sling System involves anchoring a midurethral, low-tension tape to the obturator internus muscles bilaterally at the level of the tendinous arc. Success rates in different subsets of patients are still to be defined. This work aims to identify which factors influence the 2-year outcomes of this treatment.MethodsAnalysis was based on data from a multicenter study. Endpoints for analysis included objective measurements: 1-h pad-weight (PWT), and cough stress test (CST), and questionnaires: International Consultation on Incontinence Questionnaire–Short Form (ICIQ-SF) and Urinary Distress Inventory (UDI)-6. A logistic regression analysis evaluated possible risk factors for failure.ResultsIn all, 124 female patients with stress urinary incontinence (SUI) underwent treatment with the Ophira procedure. All patients completed 1 year of follow-up, and 95 complied with the 2-year evaluation. Longitudinal analysis showed no significant differences between results at 1 and 2 years. The 2-year overall objective results were 81 (85.3 %) patients dry, six (6.3 %) improved, and eight (8.4 %) incontinent. A multivariate analysis revealed that previous anti-incontinence surgery was the only factor that significantly influenced surgical outcomes. Two years after treatment, women with previous failed surgeries had an odds ratio (OR) for treatment failure (based on PWT) of 4.0 [95 % confidence interval (CI) 1.02–15.57).ConclusionsThe Ophira procedure is an effective option for SUI treatment, with durable good results. Previous surgeries were identified as the only significant risk factor, though previously operated patients showed an acceptable success rate.

Comparison of single-incision mini-slings (Ajust) and standard transobturator midurethral slings (Align) in the management of female stress urinary incontinence: A 1-year follow-up

“…Ajust, a recently developed SIMS, has an added advantage that allows post-anchorage adjustment of the sling tension [14]. This polypropylene anchor design has been shown in independent animal studies assessing its immediate and delayed extraction forces to be associated with the strongest and most robust mechanism anchoring it to the obturator complex [14,20]. Our current study confirmed the security of the use of SIMS-Ajust in the management of female SUI, compared with conventional standard transobturator midurethral slings (SMUSAlign), suggesting that SIMS-Ajust is one of the best choices in the management of female SUI during at least the 1-year follow-up period.…”

Two‐year outcomes for the Altis® adjustable single incision sling system for treatment of stress urinary incontinence

“…The Ophira (Promedon) and MiniArc ® (Astora) trials reported 86.3% and 84.5% negative CST results, respectively, at 2‐years. One‐hour pad weight testing was used in both the Ophira and MiniArc trials to evaluate objective effectiveness.…”

“…In this study, 94 of the 113 (83.2%) enrolled subjects were available for their 24‐month follow‐up. In comparison to the single incision sling studies referenced above, the Ajust trial had 92/95 (96.8%) subjects available at 24‐months, the Ophira study had 95/124 (76.6%), and the Miniarc trial had 134/188 (71.3%) and carried forward an additional eight known failures. It is well known that completer analyses may provide optimistic estimates of treatment effects.…”

Mini-Sling Ophira at 8 Years Follow-Up: Does It Sustain Results?

“…This prospective, single-arm, open-label study was conducted to access clinical outcomes of Ophira Mini-sling System either in inpatient or outpatient basis for the treatment of female SUI in a single center, performed as described before [8]. The institutional board approved the study and all patients signed informed consent.…”