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Effect of Exercise and Biofeedback on Symptoms of Incontinence in Women With Stress Urinary Incontinence

NCT ID: NCT01337193

Last Updated: 2014-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2014-05-31

Brief Summary

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The overall purpose of this research is to determine the effect of ultrasound imaging biofeedback on urine leakage, pelvic floor muscle contractions, and quality of life in women with stress urinary incontinence. This study will include women 20 years or older with stress urinary incontinence.

The study will involve 2 groups: pelvic floor muscle (PFM) exercises with biofeedback using transabdominal Rehabilitative ultrasound imaging (RUSI) (Group A) and PFM exercises alone (Group B). The participants will perform 16 exercise sessions over a period of 8 weeks. Group A will perform 3 pelvic floor exercises using the transabdominal RUSI to provide biofeedback. Group B will perform the same 3 pelvic floor exercises without biofeedback.

All participants involved in the study will complete a general medical information questionnaire. In addition, all participants will have their PFM contraction assessed using an ultrasound machine placed over the lower abdomen, quality of life assessed with a written questionnaire, and given a 7-day bladder diary to complete prior to, at 4-weeks, and at completion of the study.

Detailed Description

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This study has been terminated.

Conditions

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Stress Urinary Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Pelvic floor muscle exercises

Three pelvic floor muscle exercises will be performed with verbal cueing from the instructor.

Group Type ACTIVE_COMPARATOR

Pelvic floor muscle exercises

Intervention Type OTHER

Exercises will b performed with verbal cueing of investigator.

Pelvic floor exercises with biofeedback

Pelvic floor exercises will be performed with biobeedback cueing.

Group Type EXPERIMENTAL

Pelvic floor exercises with biofeedback

Intervention Type OTHER

Exercises will be performed with assistance of biofeedback cueing

Interventions

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Pelvic floor exercises with biofeedback

Exercises will be performed with assistance of biofeedback cueing

Intervention Type OTHER

Pelvic floor muscle exercises

Exercises will b performed with verbal cueing of investigator.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. women will need to be 20 years or older
2. diagnosed with stress urinary incontinence (SUI).

Exclusion Criteria

women with:

1. urge or mixed incontinence
2. pelvic organ prolapse
3. previous surgical treatment for incontinence
4. current treatment for SUI (including medications)
5. current pregnancy
6. six months or less postpartum
7. body mass index of ≥ 30
8. recurrent vulvovaginitis
9. current/recurrent urinary tract infections (UTI)
10. non-English speaking.
Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Texas Woman's University

OTHER

Sponsor Role lead

Responsible Party

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Elaine Trudelle-Jackson

PhD Advisor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elaine Trudell-Jackson, PT, PhD

Role: STUDY_CHAIR

Texas Woman's University

Locations

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Texas Woman's University

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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SUI 16333

Identifier Type: -

Identifier Source: org_study_id