Trials / Completed
CompletedNCT02202031
Controlling Urgency Through Relaxation Exercises
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 161 (actual)
- Sponsor
- University of California, San Francisco · Academic / Other
- Sex
- Female
- Age
- 21 Years
- Healthy volunteers
- Accepted
Summary
We propose to conduct a rigorous, 12-week, randomized controlled trial of two relaxation therapies in 160 ambulatory women who report an average of at least 3 urgency-associated voiding or incontinence episodes per day. Participants will be randomized in a 1:1 ratio to: 1) practice slowing their resting respiratory rate to 5 to 10 breaths per minute for at least 15 minutes/day at home using a portable guided-breathing device; or 2) use an identical-appearing device that plays relaxing music while monitoring their spontaneous breathing pattern. We do not know if either of the two types of relaxation therapies is effective in treating OAB. All women will also receive a usual care pamphlet providing basic information about other traditional self-management strategies for OAB.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Paced Respiration | Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks. |
| BEHAVIORAL | Music Therapy | Participants will use an identical appearing device, programmed to play quiet, relaxing music, while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks. |
Timeline
- Start date
- 2014-09-01
- Primary completion
- 2017-12-01
- Completion
- 2018-03-01
- First posted
- 2014-07-28
- Last updated
- 2019-07-30
- Results posted
- 2019-07-05
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02202031. Inclusion in this directory is not an endorsement.