Randomized trial of a single incision versus an outside-in transobturator midurethral sling in women with stress urinary incontinence: 12 month results

• Published in: American journal of obstetrics and gynecology Vol. 213; no. 1; pp. 35.e1 - 35.e9
• Main Authors: Lee, Joseph K.-S., FRANZCOG, MD, Rosamilia, Anna, FRCOG, FRANZCOG, PhD, MD, Dwyer, Peter L., FRCOG, FRANZCOG, MD, Lim, Yik N., FRANZCOG, MD, Muller, Reinhold, PhD
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.07.2015
• Subjects: Adult; Female; Humans; Logistic Models; Middle Aged; midurethral slings; MiniArc; Monarc; Obstetrics and Gynecology; patient-reported outcomes; Prosthesis Implantation - methods; randomized controlled trial; stress urinary incontinence; Suburethral Slings; Treatment Outcome; Urinary Incontinence, Stress - physiopathology; Urinary Incontinence, Stress - surgery; Urodynamics; Urologic Surgical Procedures - methods; midurethral slings; MiniArc; patient-reported outcomes; Monarc; stress urinary incontinence; randomized controlled trial
• ISSN: 0002-9378; 1097-6868
• DOI: 10.1016/j.ajog.2015.01.040

Objective The objective of the study was to evaluate objective and subjective outcomes of MiniArc and Monarc (American Medical Systems, Minnetonka, MN) midurethral sling (MUS) in women with stress incontinence at 12 months. Study Design A total of 225 women were randomized to receive MiniArc or Monarc. Women with intrinsic sphincter deficiency, previous MUS, or untreated detrusor overactivity were excluded. Objective cure was defined as negative cough stress test with a comfortably full bladder. Subjective cure was defined as no report of leakage with coughing or exercise on questionnaire. Validated questionnaires, together with urodynamic and clinical cough stress test, were used to evaluate the objective and subjective outcomes following surgery. Participants and clinicians were not masked to treatment allocation. Outcomes were compared with exact binomial tests (eg, Fisher exact test for dichotomous data) for categorical data and Student t tests or exact versions of Wilcoxon tests for numerical data as appropriate. Results There was no statistically significant difference in the subjective (92.2% vs 94.2%; P  = .78; difference, 2.0%; 95% confidence interval, –2.7% to +6.7%) or objective (94.4% vs 96.7%; P  = .50; difference, 2.3%; 95% confidence interval, –1.5% to +6.1%) cure rates between MiniArc and Monarc at 12 m, respectively, with a significant improvement in overactive bladder outcomes and incontinence impact from baseline in both arms. Conclusion MiniArc outcomes are not inferior to Monarc MUS outcomes at 12 months’ follow-up in women without intrinsic sphincter deficiency.