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SQEASI: Systematized Quality Exercise Alternatives for Stress Incontinence

Sponsor
University of New Mexico (Other)
Overall Status
Completed
CT.gov ID
NCT03443687
Collaborator
(none)
54
Enrollment
1
Location
2
Arms
21.1
Actual Duration (Months)
2.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This randomized controlled study evaluates the effect of home biofeedback compared to pelvic floor physical therapy for the treatment of stress urinary incontinence. Half of the participants will use a home biofeedback device for 3 months and the other half will attend pelvic floor physical therapy appointments for 3 months.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Pelvic Floor Physical Therapy
  • Device: Home Biofeedback
 N/A

Detailed Description

Biofeedback has been shown to be highly effective the treatment of stress urinary incontinence when used in conjunction with pelvic floor physical therapy under the instruction of a healthcare provider. Home biofeedback has not been well studied, even though several FDA cleared devices are on the market and available for patients to purchase. It is unclear if the biofeedback improves women's urinary incontinence, or if the increased contact with a healthcare provider causes the improvement.

Using a home biofeedback device, a woman places the device in her vagina and contracts the muscles of her pelvic floor to improve the strength, which can improve or cure incontinence when performed over time. Typically it takes 3 months for benefit to be seen.

Study Design

Study Type:
Interventional
Actual Enrollment :
54 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Participants will be randomized to either Pelvic Floor Physical Therapy (PFPT) or home biofeedback. The therapy allocation will then be carried out with each arm completing 3 months of therapy.Participants will be randomized to either Pelvic Floor Physical Therapy (PFPT) or home biofeedback. The therapy allocation will then be carried out with each arm completing 3 months of therapy.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Systematized Quality Exercise Alternatives for Stress Incontinence
Actual Study Start Date :
Jun 1, 2018
Actual Primary Completion Date :
Mar 3, 2020
Actual Study Completion Date :
Mar 3, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Pelvic Floor Physical Therapy

If randomized to this arm, women will complete demographic forms and questionnaires. They will then undergo the intervention of 4 pelvic floor physical therapy visits over 3 months. At that time they will return for a follow up visit and complete questionnaires.

Behavioral: Pelvic Floor Physical Therapy
Pelvic floor exercises for 3 months under instruction of physical therapist
Other Names:
  • PFPT

    		•
    Experimental: Home Biofeedback

    If randomized to this arm, women will complete demographic forms and questionnaires. They will then be given a pelvic floor exercise device that is bluetooth linked to a smartphone application. They will be instructed on how to use the device daily for 3 months and their intervention will be to perform daily exercises with the device in place. At 3 months they will return for a follow up visit and complete questionnaires.

    Device: Home Biofeedback
    Pelvic floor exercises for 3 months using biofeedback device
    Other Names:
  • PeriCoach Kegel Exerciser

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in quality of life [3 months]

      Change in International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) score between the women who undergo PFPT compared to those to those who undergo home biofeedback therapy for stress urinary incontinence

    Secondary Outcome Measures

    1. Sexual Function [3 Months]

      Female sexual function index will be used to assess change in sexual function over study

    2. Incontinence Severity [3 months]

      Incontinence Severity Index (ISI) will be used to assess change in incontinence severity over the study period

    3. Cost comparison analysis [3 months]

      Comparative analysis of cost between PFPT treatment and home biofeedback for stress predominant incontinence

    Other Outcome Measures

    1. Satisfaction using Likert scale [3 Months]

      Likert scale will be used to assess satisfaction with treatment arm

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Female Subjects >18 years of age

    • SUI or Mixed UI with stress predominant symptoms and more bother by the SUI

    • English speaking/reading

    • Own a smartphone that can support phone application and Bluetooth for the biofeedback device

    • Willing to come for 4 PFPT visits over 3 months if randomized

    Exclusion Criteria:

    • Prior anti-incontinence surgery

    • Had prior pelvic floor physical therapy for SUI

    • Prolapse of any compartment noted below the hymen

    • Inability to speak/understand English

    • Pregnant

    • Decline or unable to return for frequent PT visits during study period

    • Unable to be contacted for follow up by telephone

    • Neurologic disorders known to cause neurogenic bladder

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of New Mexico Albuquerque New Mexico United States 87131

    Sponsors and Collaborators

    • University of New Mexico

    Investigators

    • Principal Investigator: Gena Dunivan, MD, University of New Mexico HSC, Department of Obstetrics and Gynecology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gena Dunivan, Associate Professor, University of New Mexico
    ClinicalTrials.gov Identifier:
    NCT03443687
    Other Study ID Numbers:
    • SQEASI
    First Posted:
    Feb 23, 2018
    Last Update Posted:
    Jun 12, 2020
    Last Verified:
    Jun 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Urinary Incontinence
    Enuresis
    Urinary Incontinence, Stress

    Study Results

    No Results Posted as of Jun 12, 2020