Yuko M Komesu1,2,3, Rebecca G Rogers4, Robert E Sapien4, Ronald M Schrader5, Timothy Simmerman-Sierra6, Andrew R Mayer7, Loren H Ketai4. 1. Health Sciences Center, University of New Mexico, Albuquerque, NM, USA. ykomesu@salud.unm.edu. 2. Health Sciences Center Department of Obstetrics and Gynecology, University of New Mexico, MSC10-5580, Albuquerque, NM, 87131-0001, USA. ykomesu@salud.unm.edu. 3. University of New Mexico, Albuquerque, NM, 87131-0001, USA. ykomesu@salud.unm.edu. 4. Health Sciences Center, University of New Mexico, Albuquerque, NM, USA. 5. Clinical and Translational Science Center, University of New Mexico, Albuquerque, NM, USA. 6. Hypnotherapy Academy of America, Albuquerque, NM, USA. 7. Mind Research Network, Albuquerque, NM, USA.
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.
RCT Entities:
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.
Entities:
Keywords:
Anticholinergics; Complementary alternative integrative medicine; Hypnosis/hypnotherapy; Randomized controlled trial or RCT methodology; Women with urgency urinary incontinence
Authors: Mats B O Larsson; Kirsten Tillisch; A D Craig; Maria Engström; Jennifer Labus; Bruce Naliboff; Peter Lundberg; Magnus Ström; Emeran A Mayer; Susanna A Walter Journal: Gastroenterology Date: 2011-11-19 Impact factor: 22.682
Authors: Jennifer T Anger; Helen A Nissim; Thuy X Le; Ariana L Smith; Una Lee; Catherine Sarkisian; Mark S Litwin; Shlomo Raz; Larissa V Rodriguez; Sally L Maliski Journal: Neurourol Urodyn Date: 2011-04-28 Impact factor: 2.696
Authors: Susan A Gaylord; Olafur S Palsson; Eric L Garland; Keturah R Faurot; Rebecca S Coble; J Douglas Mann; William Frey; Karyn Leniek; William E Whitehead Journal: Am J Gastroenterol Date: 2011-06-21 Impact factor: 10.864
Authors: Yuko M Komesu; Loren H Ketai; Andrew R Mayer; Terry M Teshiba; Rebecca G Rogers Journal: Female Pelvic Med Reconstr Surg Date: 2011 Impact factor: 2.091
Authors: Marie-Elisabeth Faymonville; Laurence Roediger; Guy Del Fiore; Christian Delgueldre; Christophe Phillips; Maurice Lamy; Andre Luxen; Pierre Maquet; Steven Laureys Journal: Brain Res Cogn Brain Res Date: 2003-07
Authors: Yuko M Komesu; Ronald M Schrader; Rebecca G Rogers; Robert E Sapien; Andrew R Mayer; Loren H Ketai Journal: Am J Obstet Gynecol Date: 2019-08-23 Impact factor: 8.661