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Systematized Quality Exercise Alternatives for Stress Incontinence (SQEASI)

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ClinicalTrials.gov Identifier: NCT03443687
Recruitment Status : Recruiting
First Posted : February 23, 2018
Last Update Posted : October 31, 2018
Sponsor:
Information provided by (Responsible Party):
Gena Dunivan, University of New Mexico

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
Stress Urinary Incontinence Pelvic Floor; Weak Incontinence, Urinary Quality of Life Behavioral: Pelvic Floor Physical Therapy Device: Home Biofeedback Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Systematized Quality Exercise Alternatives for Stress Incontinence
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


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 Name: 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 Name: PeriCoach Kegel Exerciser




Primary Outcome Measures :
  1. Change in quality of life [ Time Frame: 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 [ Time Frame: 3 Months ]
    Female sexual function index will be used to assess change in sexual function over study

  2. Incontinence Severity [ Time Frame: 3 months ]
    Incontinence Severity Index (ISI) will be used to assess change in incontinence severity over the study period

  3. Cost comparison analysis [ Time Frame: 3 months ]
    Comparative analysis of cost between PFPT treatment and home biofeedback for stress predominant incontinence


Other Outcome Measures:
  1. Satisfaction using Likert scale [ Time Frame: 3 Months ]
    Likert scale will be used to assess satisfaction with treatment arm



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   We will only recruit natal females who have stress urinary incontinence as device designed for females.
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03443687


Contacts
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Contact: Kara L Barnes, MD 5052723546 klbarnes@salud.unm.edu

Locations
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United States, New Mexico
University of New Mexico Recruiting
Albuquerque, New Mexico, United States, 87131
Sponsors and Collaborators
University of New Mexico
Investigators
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Principal Investigator: Gena Dunivan, MD University of New Mexico HSC, Department of Obstetrics and Gynecology

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Responsible Party: Gena Dunivan, Associate Professor, University of New Mexico
ClinicalTrials.gov Identifier: NCT03443687     History of Changes
Other Study ID Numbers: SQEASI
First Posted: February 23, 2018    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders