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Randomized trial of a single incision versus an outside-in transobturator midurethral sling in women with stress urinary incontinence: 12 month results.
Am J Obstet Gynecol. 2015 Jul; 213(1):35.e1-35.e9.AJ

Abstract

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.

Authors+Show Affiliations

Department of Urogynecology, Mercy Hospital for Women, Heidelberg, VIC, Australia; Pelvic Floor Clinic, Monash Medical Center, Moorabbin, VIC, Australia; Faculty of Medicine, University of Melbourne, Melbourne, VIC, Australia. Electronic address: joseph.lee@monashhealth.org.Pelvic Floor Clinic, Monash Medical Center, Moorabbin, VIC, Australia; Faculty of Medicine, Monash University, Melbourne, VIC, Australia.Department of Urogynecology, Mercy Hospital for Women, Heidelberg, VIC, Australia; Faculty of Medicine, University of Melbourne, Melbourne, VIC, Australia.Department of Urogynecology, Mercy Hospital for Women, Heidelberg, VIC, Australia.School of Public Health and Tropical Medicine, James Cook University, Townsville, QLD, Australia.

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

25637849

Citation

Lee, Joseph K-S, et al. "Randomized Trial of a Single Incision Versus an Outside-in Transobturator Midurethral Sling in Women With Stress Urinary Incontinence: 12 Month Results." American Journal of Obstetrics and Gynecology, vol. 213, no. 1, 2015, pp. 35.e1-35.e9.
Lee JK, Rosamilia A, Dwyer PL, et al. Randomized trial of a single incision versus an outside-in transobturator midurethral sling in women with stress urinary incontinence: 12 month results. Am J Obstet Gynecol. 2015;213(1):35.e1-35.e9.
Lee, J. K., Rosamilia, A., Dwyer, P. L., Lim, Y. N., & Muller, R. (2015). Randomized trial of a single incision versus an outside-in transobturator midurethral sling in women with stress urinary incontinence: 12 month results. American Journal of Obstetrics and Gynecology, 213(1), e1-e9. https://doi.org/10.1016/j.ajog.2015.01.040
Lee JK, et al. Randomized Trial of a Single Incision Versus an Outside-in Transobturator Midurethral Sling in Women With Stress Urinary Incontinence: 12 Month Results. Am J Obstet Gynecol. 2015;213(1):35.e1-35.e9. PubMed PMID: 25637849.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Randomized trial of a single incision versus an outside-in transobturator midurethral sling in women with stress urinary incontinence: 12 month results. AU - Lee,Joseph K-S, AU - Rosamilia,Anna, AU - Dwyer,Peter L, AU - Lim,Yik N, AU - Muller,Reinhold, Y1 - 2015/01/28/ PY - 2014/07/02/received PY - 2015/01/14/revised PY - 2015/01/26/accepted PY - 2015/2/1/entrez PY - 2015/2/1/pubmed PY - 2015/9/16/medline KW - MiniArc KW - Monarc KW - midurethral slings KW - patient-reported outcomes KW - randomized controlled trial KW - stress urinary incontinence SP - 35.e1 EP - 35.e9 JF - American journal of obstetrics and gynecology JO - Am J Obstet Gynecol VL - 213 IS - 1 N2 - 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. SN - 1097-6868 UR - https://www.unboundmedicine.com/medline/citation/25637849/Randomized_trial_of_a_single_incision_versus_an_outside_in_transobturator_midurethral_sling_in_women_with_stress_urinary_incontinence:_12_month_results_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0002-9378(15)00096-4 DB - PRIME DP - Unbound Medicine ER -