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

Texas Woman's University

Status: Terminated

Conditions: Stress Urinary Incontinence

Treatments: Other: Pelvic floor exercises with biofeedback; Other: Pelvic floor muscle exercises

Study type: Interventional

Funder types: Other

Identifiers

NCT01337193

SUI 16333

Details and patient eligibility

About

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.

Full description

This study has been terminated.

Enrollment: 28 patients

Sex: Female

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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28 participants in 2 patient groups

Pelvic floor muscle exercises

Active Comparator group

Description:

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

Treatment:

Other: Pelvic floor muscle exercises

Pelvic floor exercises with biofeedback

Experimental group

Description:

Pelvic floor exercises will be performed with biobeedback cueing.

Treatment:

Other: Pelvic floor exercises with biofeedback