Stress Urinary Incontinence, Pelvic Floor; Weak, Incontinence, Urinary, Quality of Life
Conditions
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.
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.
Interventions
DEVICEHome Biofeedback
Pelvic floor exercises for 3 months using biofeedback device
BEHAVIORALPelvic Floor Physical Therapy
Pelvic floor exercises for 3 months under instruction of physical therapist
Sponsors
University of New Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life | 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
| Measure | Time frame | Description |
|---|---|---|
| Sexual Function | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Pelvic Floor Physical Therapy: Pelvic floor exercises for 3 months under instruction of physical therapist | 27 |
| 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.
Home Biofeedback: Pelvic floor exercises for 3 months using biofeedback device | 27 |
| Total | 54 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Discontinued intervention | 1 | 1 |
| Overall Study | Lost to Follow-up | 3 | 5 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Home Biofeedback | Total | Pelvic Floor Physical Therapy |
|---|---|---|---|
| Age, Continuous | 44 years STANDARD_DEVIATION 10 | 46 years STANDARD_DEVIATION 2 | 48 years STANDARD_DEVIATION 13 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 10 Participants | 19 Participants | 9 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 9 Participants | 3 Participants |
| Race (NIH/OMB) White | 11 Participants | 25 Participants | 14 Participants |
| Sex: Female, Male Female | 27 Participants | 54 Participants | 27 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 27 |
| other Total, other adverse events | 4 / 27 | 1 / 27 |
| serious Total, serious adverse events | 0 / 27 | 0 / 27 |
Outcome results
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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pelvic Floor Physical Therapy | Change in Quality of Life | 4.73 score on a scale |
| Home Biofeedback | Change in Quality of Life | 3.95 score on a scale |
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.
Time frame: 3 Months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pelvic Floor Physical Therapy | Sexual Function | 0.42 score on a scale |
| Home Biofeedback | Sexual Function | 1.81 score on a scale |