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

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.

journal_name

Int Urogynecol J

journal_title

International urogynecology journal

authors

Komesu YM,Rogers RG,Sapien RE,Schrader RM,Simmerman-Sierra T,Mayer AR,Ketai LH

doi

10.1007/s00192-016-3169-3

subject

Has Abstract

pub_date

2017-06-01 00:00:00

pages

865-874

issue

6

eissn

0937-3462

issn

1433-3023

pii

10.1007/s00192-016-3169-3

journal_volume

28

pub_type

杂志文章

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