Status:
COMPLETED
Brain-Centered Therapy Versus Medication for Urgency Urinary Incontinence : Hypnotherapy Or Pharmacotherapy
Lead Sponsor:
University of New Mexico
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Urinary Incontinence, Urge
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This study is randomized controlled trial in which urgency incontinent women (approximately 150-160) will be randomized to hypnotherapy or pharmacotherapy and evaluated at months 2, 6 \&12 Hypotheses:...
Detailed Description
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...
Eligibility Criteria
Inclusion
- (For randomized trial)
- Non-pregnant English-speaking women
- 18 yo or older
- Overactive Bladder (OAB) Awareness scores ≥ 8
- 3 UUI episodes/week for ≥ 3 months
Exclusion
- (For Randomized trial)
- Women with a history of neurologic diseases such as Multiple Sclerosis, Parkinson's disease, stroke, or dementia
- History of schizophrenia or untreated bipolar disorder or current drug or alcohol dependence
- 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
- Contraindications to anticholinergic medications (untreated narrow angle glaucoma, significant urinary retention or gastric retention)
- 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)
- Untreated urinary tract infection
- Prolapse which extends past the hymen (POP-Q points of ≥ 1+) which may be responsible for UUI symptoms
- 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.
Key Trial Info
Start Date :
April 22 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 27 2017
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT01829425
Start Date
April 22 2013
End Date
October 27 2017
Last Update
April 23 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of New Mexico Health Science Center
Albuquerque, New Mexico, United States, 87131