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

Not Applicable

Completed

• Conditions: Mixed Urinary Incontinence; Stress Urinary Incontinence

• Registration Number: NCT03632447
• Lead Sponsor: Renovia, Inc.

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.

Study Timeline

• Study First Submitted: 2018-08-13
• Study First Submitted QC: 2018-08-13
• Study First Posted: 2018-08-15
• Study Start: 2018-10-24
• Status Verified: 2019-07
• Primary Completion: 2019-08-01
• Study Completion: 2019-10-01
• Last Update Submitted: 2020-10-06
• Last Update Posted: 2020-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 77

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
3-day voiding diary	8 weeks after randomization	An objective evaluation of urinary incontinence

Trial Locations

Locations (7)

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