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

NCT01337193 | Terminated

• 1 other identifier: SUI 16333
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stress Urinary Incontinence

Keywords

stress urinary incontinence; exercise; pelvic floor muscles; biofeedback; rehabilitative ultrasound imaging

Outcome Measures

Primary Outcomes (1)

• Change in the ability to contract the pelvic floor muscles from baseline to the midpoint and completion of the study

  Pelvic floor muscle lift and length of pelvic floor muscle contraction will be measured using transabdominal ultrasound imaging. Ability to maintain continence during a cough will be measured by asking the participant to stand, contract the pelvic floor muscles, and cough. The participant will state whether or not they leaked urine.

  baseline, 4 weeks, and 8 weeks

Secondary Outcomes (2)

• Change in the number of incontinent episodes per week from baseline to the midpoint and conclusion of the study

  Baseline, 4 weeks, and 8 weeks

• Change in quality of life from the baseline to the midpoint and completion of the study

  Baseline, 4 weeks, and 8 weeks

Study Arms (2)

Pelvic floor muscle exercises

ACTIVE COMPARATOR

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

Other: Pelvic floor muscle exercises

Pelvic floor exercises with biofeedback

EXPERIMENTAL

Pelvic floor exercises will be performed with biobeedback cueing.

Other: Pelvic floor exercises with biofeedback

Interventions

Pelvic floor exercises with biofeedback OTHER

Exercises will be performed with assistance of biofeedback cueing

Pelvic floor exercises with biofeedback

Pelvic floor muscle exercises OTHER

Exercises will b performed with verbal cueing of investigator.

Pelvic floor muscle exercises

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• women with:
• urge or mixed incontinence
• pelvic organ prolapse
• previous surgical treatment for incontinence
• current treatment for SUI (including medications)
• current pregnancy
• six months or less postpartum
• body mass index of ≥ 30
• recurrent vulvovaginitis
• current/recurrent urinary tract infections (UTI)
• non-English speaking.

Sponsors & Collaborators

• Texas Woman's University: lead

Study Sites (1)

Texas Woman's University

Dallas, Texas, 75235, United States

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress; Motor Activity

Interventions

Biofeedback, Psychology

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Officials

• Elaine Trudell-Jackson, PT, PhD

  Texas Woman's University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Advisor

Study Record Dates

• First Submitted: April 1, 2011
• First Posted: April 18, 2011
• Study Start: February 1, 2011
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: November 14, 2014

Record last verified: 2014-11

Locations

US (1)