Brain-Centered Therapy Versus Medication for Urgency Urinary Incontinence : Hypnotherapy Or Pharmacotherapy

Study Objectives Primary: To compare change in Urgency Urinary Incontinence (UUI) episodes at
2 month follow-up on voiding diaries between hypnotherapy and pharmacotherapy groups (to
determine whether hypnotherapy is at least as effective and durable in treating UUI as
pharmacotherapy)

Secondary Analyses:

- To determine whether hypnotherapy is at least as effective in treating UUI as
pharmacotherapy comparing change in UUI episodes on voiding diary at 6 and 12 month
follow-up

- To determine whether hypnotherapy differs from pharmacotherapy in treating UUI comparing
change in questionnaire results and urinary frequency

- enrolled following administration of the Overactive Bladder (OAB) Awareness tool.
Participants will keep voiding diaries then be randomized to either pharmacotherapy and
conventional behavioral therapy or hypnotherapy and conventional behavioral therapy.
Approximately 150-160 women will be randomized.

Randomization will occur using a computer-generated randomization scheme in varying permuted
block sizes. Study personnel performing data entry will be masked to participants' treatment.
Masking participants to treatment is not feasible. Participants will be followed at 2,6 & 12
months. Measurements will be performed before treatment, following completion of treatment
visits (approximately 8 weeks), and at 6 and 12 months. Primary analysis will be intention to
treat. Exploratory analyses of secondary outcomes will also be performed.

Study Visits: UUI participant screening: Study information given. Screening questionnaire
given. Visit 1 Enrollment: Formal screening for eligibility, voiding diary reviewed, if
eligible, written consent obtained with administration of study questionnaires, demographic
and past medical history administration forms, Pelvic Organ Prolapse Quantitation (POP-Q)
exam & hypnotic susceptibility testing scheduled. Pariticipants undergo hypnotic
susceptibility testing prior to randomization. Participants randomized to treatment and
contacted, treatments arranged. Hypnotherapy group: undergo weekly treatments over 8 weeks.
Pharmacotherapy group: weekly counseling sessions over 8 week: Following hypnotherapy or
medication counseling completion, f/u voiding diaries collected & study questionnaires
administered. One of two long acting anti-cholinergic medications offered (Long acting
Tolterodine or Extended Release Oxybutynin or equivalent generic substitutes).

6 & 12 month follow-up: Pharmacotherapy subjects receive medications for 1 year and
Hypnotherapy subjects encouraged to continue self-hypnosis for 1 year with assistance of
audio-recordings, with 1 optional hypnotherapy session between 6-12 months..

Participants informed pharmacotherapy & hypnotherapy sessions are audio-recorded and reviewed
ensuring manual of procedures are followed.

Inclusion Criteria:(For randomized trial)

1. Non-pregnant English-speaking women

2. 18 yo or older

3. Overactive Bladder (OAB) Awareness scores ≥ 8

4. 3 UUI episodes/week for ≥ 3 months

Exclusion Criteria: (For Randomized trial)

1. Women with a history of neurologic diseases such as Multiple Sclerosis, Parkinson's
disease, stroke, or dementia

2. History of schizophrenia or untreated bipolar disorder or current drug or alcohol
dependence

3. Women who have taken anticholinergic medications for UUI within the last 3 weeks
(women who have taken anti-cholinergics for UUI but discontinued them > than 3 weeks
ago may participate in the study) or have a sacral neuromodulator in place to treat
UUI or have received Onabotulinum toxin A in the last 12 months to treat UUI

4. Contraindications to anticholinergic medications (untreated narrow angle glaucoma,
significant urinary retention or gastric retention)

5. Pregnant women or lactating women, women who plan to become pregnant in the next year,
or pre-menopausal women unwilling to use contraception if engaging in sexual relations
during the year of study participation (hysterectomy is considered to be a form of
contraception)

6. Untreated urinary tract infection

7. Prolapse which extends past the hymen (POP-Q points of ≥ 1+) which may be responsible
for UUI symptoms

8. Women who cannot keep the majority of the study therapy appointments or those without
reliable contact phone numbers or methods of communication with the study personnel.