CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
RESPeRATE +1 moredevice
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/NCT01048424
NCT01048424N/ACompleted

Slow Paced-Respiration Intervention to Reduce Incontinence Trial (SPIRIT)

University of California, San Francisco·interventional·Posted Jan 13, 2010·Updated Nov 21, 2013

In Brief

A clinical study evaluating RESPeRATE and Urinary Incontinence Pamphlet for Urinary Incontinence, Urge. Completed, enrolled 20 participants across 1 site.

Detailed Summary

Urgency incontinence is a common and burdensome problem in women. Current treatments for this condition, while effective, are associated with potentially disabling side effects and high rates of discontinuation. There is an urgent need for alternate treatments for urgency incontinence that are both clinically effective and well-tolerated by women in the community. RESPeRATE is a commercially available "walkman-like" device that measures chest/abdominal excursion during respiration using an elastic belt with a sensor placed around the torso over clothing. The device senses respiration and uses musical tones keyed to inhalation and exhalation to help the user slow respiration and prolong exhalation to a recommended goal of less than 10 breaths per minute. RESPeRATE is approved by the US Food and Drug Administration (FDA) for treatment of mild hypertension, and use of the device has also been shown to decrease self-reported anxiety and stress, oxygen consumption, and respiratory rate. Because anxiety and stress are strongly associated with urgency incontinence, and common behavioral strategies for managing incontinence emphasize relaxation and slow breathing at the time of an urgency episode, paced respiration may also be useful in treating urgency incontinence and/or decreasing its burden on quality of life. We propose to conduct a 6-week pilot randomized controlled trial of slow paced respiration using the RESPeRATE device among 30 women with urgency incontinence to assess the feasibility of recruiting and teaching women to use the RESPeRATE device as well as to gather preliminary data on the efficacy of slow paced respiration for treatment of urgency incontinence and related symptoms. Participants will complete a 7-day voiding diary and complete questionnaires to measure outcome.

Study Details

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

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 13, 2010
Enrollment StartJan 1, 2010
Primary CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 16.5 years ago

Interventions

RESPeRATEdevice

RESPeRATE is a commercially available, "walkman-like" device manufactured by Intercure, Ltd. that measures chest/abdominal excursion during respiration using an elastic belt with a sensor placed around the torso over clothing. The device senses respiration and uses musical tones keyed to inhalation and exhalation to help the user slow respiration and prolong exhalation to a recommended goal of less than 10 breaths per minute. RESPeRATE is approved by the FDA for treatment of mild hypertension and has also been shown to decrease self-reported anxiety and stress, oxygen consumption, and respiratory rate.

Urinary Incontinence Pamphletother

The urinary incontinence pamphlet will provide information about classification, pathophysiology, and management of urinary incontinence, including management strategies such as timed urination and pelvic muscle exercises.