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

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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.

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Authors and Affiliations

  1. Health Sciences Center, University of New Mexico, Albuquerque, NM, USA

    Yuko M. Komesu, Rebecca G. Rogers, Robert E. Sapien & Loren H. Ketai

  2. Health Sciences Center Department of Obstetrics and Gynecology, University of New Mexico, MSC10-5580, Albuquerque, NM, 87131-0001, USA

    Yuko M. Komesu

  3. University of New Mexico, Albuquerque, NM, 87131-0001, USA

    Yuko M. Komesu

  4. Clinical and Translational Science Center, University of New Mexico, Albuquerque, NM, USA

    Ronald M. Schrader

  5. Hypnotherapy Academy of America, Albuquerque, NM, USA

    Timothy Simmerman-Sierra

  6. Mind Research Network, Albuquerque, NM, USA

    Andrew R. Mayer

Authors
  1. Yuko M. Komesu
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  2. Rebecca G. Rogers
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  3. Robert E. Sapien
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  4. Ronald M. Schrader
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  5. Timothy Simmerman-Sierra
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  6. Andrew R. Mayer
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  7. Loren H. Ketai
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Corresponding author

Correspondence to Yuko M. Komesu.

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Conflicts of interest

Y.K., L.K., R.R., R.E.S., R.M.S. and A.M. receive research support from NIH grant R01AT007171.

The following authors have additional disclosures:

R.R.: UpToDate author, American Board Obstetrics and Gynecology, American College Obstetrics and Gynecology author, International Urogynecologic Association editor.

R.E.S.: International Board of Hypnotherapy President, Board Member Global Hypnotherapy Advancement Foundation.

T.S.-S.: International Board of Hypnotherapy, Board Member Global Hypnotherapy Advancement Foundation.

Funding

The research reported here was supported by the National Center for Complementary and Integrative Health of the National Institutes of Health under Award Number R01AT007171, the National Center for Research Resources and the National Center for Advancing Translational Sciences of the National Institutes of Health through (grant number 8UL1TR000041), and the University of New Mexico Clinical and Translational Science Center.

The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

The study is registered with ClinicalTrials.gov (https://clinicaltrials.gov, ID NCT01829425).

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Komesu, Y.M., Rogers, R.G., Sapien, R.E. et al. Methodology for a trial of brain-centered versus anticholinergic therapy in women with urgency urinary incontinence. Int Urogynecol J 28, 865–874 (2017). https://doi.org/10.1007/s00192-016-3169-3

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  • DOI: https://doi.org/10.1007/s00192-016-3169-3

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