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OpenTrials
Completed

NCT Number: NCT03443687

Systematized Quality Exercise Alternatives for Stress Incontinence

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pelvic floor physical therapy

Behavioral

Pelvic floor exercises for 3 months under instruction of physical therapist

Other names: PFPT

Home Biofeedback

Device

Pelvic floor exercises for 3 months using biofeedback device

Other names: PeriCoach Kegel Exerciser

Primary outcomes

  1. Change in Quality of Life

    Time frame: 3 months

    Scale is International Consultation Incontinence Questionnaire short form (ICIQ-SF). Minimum is 0 and Maximum is 21. A higher score indicates greater impairment from incontinence.

Secondary outcomes

  1. Sexual Function

    Time frame: 3 Months

    Female sexual index will be used to assess change in sexual function over study. Female sexual function index (FSFI) questionnaire and Pelvic organ prolapse incontinence sexual questionnaire were PI developed questionnaires. The minimum is 0 and the maximum is 36. A higher score indicates greater sexual impairment.

Sponsors and collaborators

Lead sponsor

University of New Mexico

Other

Registry information

Acronym: SQEASI

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Feb 23, 2018
Registry last updated
Dec 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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