Stress Urinary Incontinence Clinical Trial
Official title:
A Prospective Randomized Efficacy Study Comparing a Pelvic Digital Health System Home Program of Pelvic Floor Muscle Exercise to Kegel Exercises in the Treatment of Stress-Predominant Urinary Incontinence
NCT number | NCT03632447 |
Other study ID # | REN-05 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 24, 2018 |
Est. completion date | October 1, 2019 |
Verified date | July 2019 |
Source | Renovia, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A randomized controlled trial for patients with stress urinary incontinence or stress-dominant mixed incontinence. Subjects will be randomized to 8-weeks of home kegel exercises or 8 weeks of pelvic floor muscle exercises using the leva digital pelvic health system that includes visual biofeedback via smartphone.
Status | Completed |
Enrollment | 77 |
Est. completion date | October 1, 2019 |
Est. primary completion date | August 1, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 89 Years |
Eligibility |
Inclusion Criteria: - Capable of giving informed consent. - Self-reported stress-type UI symptoms of >= three months duration - Diagnosis of stress predominant urinary incontinence based on MESA stress symptom score greater than MESA urge symptom score (percent of total possible urge score). - UDI-6 score >/= 25 - Willing to participate in the 8-week study with follow up at 6-and 12-months, refraining from the pursuit of treatment for Stress Urinary Incontinence using other modalities (i.e. will not wear a pessary, participate in pelvic floor PT or surgery) during the first 8- weeks. Exclusion Criteria: - Absence of a vagina. - Age <18 years. - Stage 3-4 pelvic organ prolapse (as determined by POP-Q). - Diagnosis of any neuromuscular disease. - Non-ambulatory. - Currently pregnant or <12 months post-partum. - </= 3 months after failed surgery for stress urinary incontinence. - Previous pelvic floor muscle training (PFMT) within the last 12 months under a supervised therapeutic plan of care. - Currently taking, or has taken within the last 2 months, medication to treat urinary incontinence. - Prior augmentation cystoplasty or artificial sphincter. - Implanted nerve stimulator for urinary symptoms. - Participation in another clinical study within 30 days of screening. - Impaired cognitive function. - Contraindication to the use of a vaginal probe. - Unable to understand instructions on the use of the leva® Plus Pelvic Digital Health System. - Unable to actively recruit the pelvic floor muscles to any degree for attempted volitional contraction. |
Country | Name | City | State |
---|---|---|---|
United States | Cedars-Sinai Medical Group | Beverly Hills | California |
United States | University of Alabama | Birmingham | Alabama |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | Northwestern University | Chicago | Illinois |
United States | Cleveland Clinic | Cleveland | Ohio |
United States | Univeristy of Oklahoma | Oklahoma City | Oklahoma |
United States | Urology San Antonio | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
Renovia, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Adherence | Adherence to the exercise regimen will be evaluated | 8 weeks, 6 months, 12 months | |
Primary | PGI-I | PGI-I, Patient Global Impression of Improvement, is a five-point scale that ranges from "not at all" to "very much better." | 8 weeks after randomization | |
Primary | UDI-6 | Urogenital Distress Inventory is a six question validated questionnaire evaluating incontinence symptoms. It is scored from 0-100, with higher scores indicating more severely bothersome symptoms | 8 weeks after randomization | |
Secondary | 3-day voiding diary | An objective evaluation of urinary incontinence | 8 weeks after randomization |
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