Mixed Urinary Incontinence, Stress Urinary Incontinence
Conditions
Keywords
Digital Health, Female
Brief summary
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.
Detailed description
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. Leva subjects will perform guided pelvic floor muscle exercises for 2 1/2 minutes twice daily. Home kegel subjects will perform kegel exercises three times daily. Following 8-weeks of training, subjects will be permitted to continue the exercises or pursue additional therapies as indicated. Subjects randomized to the leva digital health system will be further randomized to receive automated reminders for the remainder of one year, or no additional reminders.
Interventions
DEVICELeva
Subjects randomized to Leva will use a vaginal probe containing motion-based sensors to direct the performance of pelvic muscle exercises.
DEVICEPFDx
All subjects (in both study arms) will be evaluated using a vaginally placed device that will evaluate pelvic floor motion to document change in pelvic floor muscle function resulting from pelvic floor muscle exercises.
Sponsors
Renovia, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Assessments of pelvic floor muscle function accomplished by testing at baseline, 4-weeks (mid-study) and 8-weeks will be performed by blinded assessor
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 89 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PGI-I | 8 weeks after randomization | PGI-I, Patient Global Impression of Improvement, is a five-point scale that ranges from not at all to very much better. |
| UDI-6 | 8 weeks after randomization | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 3-day voiding diary | 8 weeks after randomization | An objective evaluation of urinary incontinence |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adherence | 8 weeks, 6 months, 12 months | Adherence to the exercise regimen will be evaluated |
Countries
United States
Outcome results
None listed