Hypnotherapy for Treatment of Overactive Bladder: A Feasibility Study

Experimental Design and Methods:

i) This is a feasibility study (prior to performing a larger randomized controlled trial at a later date) evaluating whether hypnotherapy effectively treats Overactive Bladder (OAB). Ultimately, for the larger study, in order to find a 20% difference between the hypnotherapy group and controls, we will need to evaluate a total of approximately 66-70 women to find a 20% difference between groups, assuming 80% power and P=0.05. However, the purpose of this pilot study is to evaluate the feasibility of the larger study and determine the appropriate control intervention and outcomes. We plan to evaluate approximately ten subjects (approximately twenty overall) in both the control and hypnotherapy groups.

ii) Patients OAB will be offered entry into the study. a) Inclusion criteria: women experiencing 8 voids/day and an OAB Awareness tool score greater than 8. b) Exclusion criteria: males (since we do not care for males in the gynecology clinic), non-English speakers, pregnant women, women younger than 18 years old, incarcerated women, women with a history of bipolar disorder or schizophrenia, women unwilling to undergo hypnotherapy iii) Informed consent will be obtained. iv) Prior to receiving interventions, patients will be administered the OAB-q & instructed to keep a 3 day voiding diary. If the patient has not had a pelvic exam in the urogynecology clinic within the last year, a pelvic exam will be performed.

v) The usual standard treatments for OAB include pelvic floor exercise, voiding diaries, bladder drills (increasing time between voids), and anti-cholinergic medications. The control group will be offered any or all of our standard treatments, including Behavioral treatment (review of voiding diaries and instruction regarding behavioral changes). Both groups will be allowed to continue current OAB medications but asked not to start new medications. The hypnotherapy group will also be offered any or all of our standard treatments, but they will be given the option of receiving hypnotherapy in addition to the usual treatments.

vi) Hypnotherapy sessions: Dr. Sapien will conduct 3 hypnotherapy session to women randomized to the hypnotherapy group. These sessions will occur approximately every1-2 weeks over approximately a time span of 6-8 weeks. The sessions will last 60-90 minutes. Session #1) Explain hypnotherapy and practice suggestion therapy; Session #2) address emotions around OAB and life impact, visualization of pelvic floor exercise mechanics, teach self hypnosis; Session #3) address emotions, further practice on exercises and self-hypnosis vii) Blinding of Investigators and Allocation Concealment: Randomization will be performed by the CTSC using computer generated allocation. Only the CTSC personnel will know the assignment schema. Researchers will not know the group assignments. A research nurse otherwise uninvolved in the study will place the group assignments in serially numbered, opaque envelopes. Once subjects sign consents they will receive an opaque envelop assigning them to the Behavioral Therapy or Hypnotherapy group. The individual responsible for data collection and data entry will not know the group assignment until the end of the study when the assignment code is broken.