Systematized Quality Exercise Alternatives for Stress Incontinence

Quality of Life Clinical Trial

— SQEASI  

Official title:

Systematized Quality Exercise Alternatives for Stress Incontinence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03443687
• Other study ID #: SQEASI
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: March 3, 2020

Study information

• Verified date: December 2023
• Source: University of New Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: March 3, 2020
• Est. primary completion date: March 3, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Incontinence, Urinary
• Pelvic Floor; Weak
• Quality of Life
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

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

Device:
• Home Biofeedback
Pelvic floor exercises for 3 months using biofeedback device

Locations

Country	Name	City	State
United States	University of New Mexico	Albuquerque	New Mexico

Sponsors (1)

Lead Sponsor	Collaborator
University of New Mexico

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Quality of Life	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.	3 months
Secondary	Sexual Function	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.	3 Months