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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03632447
• Other study ID #: REN-05
• Status: Completed
• Phase: N/A
• Start date: October 24, 2018
• Est. completion date: October 1, 2019

Study information

• Verified date: July 2019
• Source: Renovia, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Enuresis
• Mixed Urinary Incontinence
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Device:
• Leva
Subjects randomized to Leva will use a vaginal probe containing motion-based sensors to direct the performance of pelvic muscle exercises.
• PFDx
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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Renovia, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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