OBJECTIVE: To evaluate objective and subjective outcomes of MiniArc and Monarc midurethral sling (MUS) in women with stress incontinence at 12 months.
STUDY DESIGN: 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 (CST) 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 objective and subjective outcomes following surgery. Participants and clinicians were not masked to treatment allocation. Outcomes were compared with exact binomial tests (e.g. Fischer's 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=0.78; difference 2.0%, 95%CI[-2.7%, +6.7%]) or objective (94.4% vs 96.7%, p=0.50; difference 2.3%, 95%CI[-1.5%, +6.1%]) cure rates between MiniArc and Monarc at 12m respectively, with a significant improvement in overactive bladder outcomes and incontinence impact from baseline in both arms.
CONCLUSIONS: MiniArc outcomes are not inferior to Monarc MUS outcomes at 12 months follow up in women without intrinsic sphincter deficiency.
Written by:
Lee JK, Rosamilia A, Dwyer PL, Lim YN, Muller R. Are you the author?
Dept Urogynaecology Mercy Hospital for Women, Heidelberg. Victoria, Australia; Pelvic Floor Clinic Monash Medical Centre, Moorabin. Victoria, Australia; University of Melbourne; Monash University; School of Public Health & Tropical Medicine, James Cook University, Townsville, Queensland.
Reference: Am J Obstet Gynecol. 2015 Jan 28. pii: S0002-9378(15)00096-4.
doi: 10.1016/j.ajog.2015.01.040
PubMed Abstract
PMID: 25637849