CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 161 enrolled
Drug / intervention
Paced Respiration +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02202031
NCT02202031N/ACompleted

Controlling Urgency Through Relaxation Exercises

University of California, San Francisco·interventional·Posted Jul 28, 2014·Updated Jul 30, 2019

In Brief

A clinical study evaluating Paced Respiration and Music Therapy for Overactive Bladder and 2 related conditions. Completed, enrolled 161 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 28, 2014
Enrollment StartSep 1, 2014
Primary CompletionDec 1, 2017
Study CompletionMar 1, 2018
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 11.9 years ago

Interventions

Paced Respirationbehavioral

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.

Music Therapybehavioral

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.