Methodology for a trial of brain-centered versus anticholinergic therapy in women with urgency urinary incontinence - PubMed (original) (raw)

Methodology for a trial of brain-centered versus anticholinergic therapy in women with urgency urinary incontinence

Yuko M Komesu et al. Int Urogynecol J. 2017 Jun.

Abstract

Introduction and hypothesis: We describe the rationale and methodology for a study comparing mind-body treatment and pharmacotherapy in women with urgency urinary incontinence (UUI). To explore brain associations in UUI, a subset of patients will also undergo functional magnetic resonance imaging (fMRI). We hypothesize that hypnotherapy, a mind-body intervention, will be at least as effective as pharmacotherapy in treating UUI. We also hypothesize that fMRI findings will change following treatment, with changes potentially differing between groups.

Methods: We describe the development and design challenges of a study comparing the efficacy of hypnotherapy and conventional pharmacotherapy in the treatment of UUI. The study randomizes women to either of these treatments, and outcome measures include bladder diaries and validated questionnaires. Sample size estimates, based on a noninferiority test (alpha = 0.025, beta = 0.20), after considering dropout subjects and subjects lost to follow-up, indicated that approximately 150 woman would be required to test the hypothesis that hypnotherapy is not inferior to pharmacotherapy within a 5 % noninferiority margin. The study will also evaluate fMRI changes in a subset of participants before and after therapy. Challenges included designing a study with a mind-body therapy and a comparison treatment equally acceptable to participants, standardizing the interventions, and confronting the reality that trials are time-consuming for participants who have to make appropriate accommodations in their schedule.

Results: Study enrollment began in March 2013 and is ongoing.

Conclusions: We describe the design of a randomized controlled trial comparing mind-body therapy and pharmacotherapy in the treatment of UUI and the challenges encountered in its implementation.

Keywords: Anticholinergics; Complementary alternative integrative medicine; Hypnosis/hypnotherapy; Randomized controlled trial or RCT methodology; Women with urgency urinary incontinence.

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Participant Flow Diagram

References

    1. Coyne KS, Wein A, Nicholson S, Kvasz M, Chen CI, Milsom I. Comorbidities and personal burden of urgency urinary incontinence: a systematic review. Int J Clin Pract. 2013;67(10):1015–33. -PubMed
    1. Milsom I, Coyne KS, Nicholson S, Kvasz M, Chen CI, Wein AJ. Global prevalence and economic burden of urgency urinary incontinence: a systematic review. Eur Urol. 2014;65(1):79–95. -PubMed
    1. Shamliyan T, Wyman J, Kane RL. Nonsurgical Treatments for Urinary Incontinence in Adult Women: Diagnosis and Comparative Effectiveness. Rockville, MD: Agency for Healthcare Research and Quality; Apr, 2012. (Comparative Effectiveness Review No. 36. (Prepared by the University of Minnesota Evidence-based Practice Center under Contract No. HHSA 290-2007-10064-I.) AHRQ Publication No. 11(12)-EHC074-EF). Available at: www.effectivehealthcare.ahrq.gov/reports/final.cfm. Last accessed 6/1/2016. -PubMed
    1. Anger JT, Nissim HA, Le TX, Smith AL, Lee U, Sarkisian C, et al. Women’s experience with severe overactive bladder symptoms and treatment: insight revealed from patient focus groups. Neurourol Urodyn. 2011;30(7):295–9. -PMC -PubMed
    1. Hubbard CS, Hong J, Jiang Z, Ebrat B, Suyenobu B, Smith S, et al. Increased attentional network functioning related to symptom severity measures in females with irritable bowel syndrome. Neurogastroenterol Motil. 2015;27(9):1282–94. -PMC -PubMed

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