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Controlling Urgency Through Relaxation Exercises

NCT02202031 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 161

Last updated 2019-07-30

Study results available
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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

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.

Sponsors & Collaborators

Principal Investigators

  • Alison Huang, MD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2017-12-31
Completion
2018-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02202031 on ClinicalTrials.gov