Clinical trial NCT03632447: Comparing Use of a Digital Health System of Pelvic Floor Exercise Program to Kegel Exercises in Stress Urinary Incontinence
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Mixed Urinary Incontinence
Keywords: Digital Health
Female
Lead sponsor: Renovia, Inc.
Sponsor class: INDUSTRY
First posted: 2018-08-15
Enrollment: 77
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: PGI-I
timeFrame: 8 weeks after randomization
measure: UDI-6
timeFrame: 8 weeks after randomization
Secondary outcomes:
measure: 3-day voiding diary
timeFrame: 8 weeks after randomization
Other outcomes:
measure: Adherence
timeFrame: 8 weeks, 6 months, 12 months
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Beverly Hills
country: United States
facility: Cedars-Sinai Medical Group
state: California
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Oklahoma City
country: United States
facility: Univeristy of Oklahoma
state: Oklahoma
city: San Antonio
country: United States
facility: Urology San Antonio
state: Texas
Study officials:
References: