Systematized Quality Exercise Alternatives for Stress Incontinence (SQEASI)
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|ClinicalTrials.gov Identifier: NCT03443687|
Recruitment Status : Active, not recruiting
First Posted : February 23, 2018
Last Update Posted : October 21, 2019
|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|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|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)|
|Official Title:||Systematized Quality Exercise Alternatives for Stress Incontinence|
|Actual Study Start Date :||June 1, 2018|
|Estimated Primary Completion Date :||December 30, 2019|
|Estimated Study Completion Date :||December 30, 2019|
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
- 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
- Sexual Function [ Time Frame: 3 Months ]Female sexual function index will be used to assess change in sexual function over study
- Incontinence Severity [ Time Frame: 3 months ]Incontinence Severity Index (ISI) will be used to assess change in incontinence severity over the study period
- Cost comparison analysis [ Time Frame: 3 months ]Comparative analysis of cost between PFPT treatment and home biofeedback for stress predominant incontinence
- Satisfaction using Likert scale [ Time Frame: 3 Months ]Likert scale will be used to assess satisfaction with treatment arm
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
|United States, New Mexico|
|University of New Mexico|
|Albuquerque, New Mexico, United States, 87131|
|Principal Investigator:||Gena Dunivan, MD||University of New Mexico HSC, Department of Obstetrics and Gynecology|