An interventional study of Pelvic Floor Physical Therapy and Home Biofeedback in Stress Urinary Incontinence, Pelvic Floor; Weak and Incontinence, Urinary, sponsored by University of New Mexico. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-21.
Sponsored by University of New Mexico · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
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
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 under instruction of physical therapist
Also known as: PFPT
Pelvic floor exercises for 3 months using biofeedback device
Also known as: PeriCoach Kegel Exerciser
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.
Time frame: 3 months
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.
Time frame: 3 Months
| Milestone | Pelvic Floor Physical Therapy | Home Biofeedback |
|---|---|---|
| Started | 27 | 27 |
| Completed | 22 | 21 |
| Not completed | 5 | 6 |
| Withdrew: Lost to follow-up | 3 | 5 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Discontinued intervention | 1 | 1 |
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.
| score on a scale | Pelvic Floor Physical Therapy | Home Biofeedback |
|---|---|---|
| Change in Quality of Life | 4.73 (3.21 to 6.25) | 3.95 (2.21 to 5.70) |
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.
| score on a scale | Pelvic Floor Physical Therapy | Home Biofeedback |
|---|---|---|
| Sexual Function | 0.42 (0 to 36) | 1.81 (0 to 36) |
Collected over 3 months. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pelvic Floor Physical Therapy | 0/27 (0%) | 0/27 (0%) | 4/27 (14.8%) |
| Home Biofeedback | 0/27 (0%) | 0/27 (0%) | 1/27 (3.7%) |
| Event | Pelvic Floor Physical Therapy | Home Biofeedback |
|---|---|---|
| infectionInfections and infestations | 2/27 | 0/27 |
| vaginal infectionInfections and infestations | 1/27 | 1/27 |
| Vaginal discharge without infectionInfections and infestations | 1/27 | 0/27 |
| Age, Continuous(years) | Pelvic Floor Physical Therapy | Home Biofeedback | Total |
|---|---|---|---|
| Mean | 48 ± 13 | 44 ± 10 | 46 ± 2 |
| Sex: Female, Male(Participants) | Pelvic Floor Physical Therapy | Home Biofeedback | Total |
|---|---|---|---|
| Female | 27 | 27 | 54 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Pelvic Floor Physical Therapy | Home Biofeedback | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 14 | 11 | 25 |
| More than one race | 9 | 10 | 19 |
| Unknown or Not Reported | 3 | 6 | 9 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of New Mexico