Comparing Use of a Digital Health System of Pelvic Floor Exercise Program to Kegel Exercises in Stress Urinary Incontinence

Completed · Not applicable

Conditions studied: Stress Urinary Incontinence, Mixed Urinary Incontinence

In brief

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.

Key facts

Study ID

NCT03632447

Run by

Renovia, Inc.

People needed

77

Starts

2018-10-24

Expected to finish

2019-10-01

Last updated by the study team

2020-10-08

Who can join

Age: 18 and older, up to 89. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• Cedars-Sinai Medical Group — Beverly Hills, California, United States
• Northwestern University — Chicago, Illinois, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Univeristy of Oklahoma — Oklahoma City, Oklahoma, United States
• Urology San Antonio — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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