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

NCT03632447 | Completed FDA Device

• 1 other identifier: REN-05
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 7

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.

Conditions

Stress Urinary Incontinence; Mixed Urinary Incontinence

Keywords

Digital Health; Female

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• 3-day voiding diary

  8 weeks after randomization

Other Outcomes (1)

• Adherence

  8 weeks, 6 months, 12 months

Study Arms (2)

Leva Arm

EXPERIMENTAL

Subjects will undergo pelvic floor muscle training using the leva device (a vaginal probe) which provides immediate visual feedback via smartphone regarding the motion of pelvic floor muscles. Subjects will perform exercises 2 1/2 minutes twice daily for 8 weeks. At the beginning of the study, four weeks later, and eight weeks later subjects will undergo pelvic floor muscle testing using the PFDx device and surveys to document response to training. After eight weeks, subjects may pursue any additional treatments they wish, but may continue to use the device. They will be further randomized to receive reminder text messages or no messages over 10 months. Subjects will be asked to complete follow up surveys at 6- and 12-months.

Device: Leva; Device: PFDx

Kegel Arm

ACTIVE COMPARATOR

Subjects in this arm will perform pelvic floor muscle exercises (Kegels) for the treatment of stress or mixed urinary incontinence. Subjects will be asked to perform exercises three times daily for 8 weeks. At the beginning of the study, four weeks later, and eight weeks later, subjects will undergo pelvic floor muscle testing (using the PFDx device) and surveys to document response to training. After eight weeks, subjects may pursue any additional treatments they wish, but may continue to use the device.

Device: PFDx

Interventions

Leva DEVICE

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

Leva Arm

PFDx DEVICE

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.

Kegel Arm; Leva Arm

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Renovia, Inc.: lead

Study Sites (7)

University of Alabama

Birmingham, Alabama, 35233, United States

Location

Cedars-Sinai Medical Group

Beverly Hills, California, 90211, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Univeristy of Oklahoma

Oklahoma City, Oklahoma, 73104, United States

Location

Urology San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessments of pelvic floor muscle function accomplished by testing at baseline, 4-weeks (mid-study) and 8-weeks will be performed by blinded assessor
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2018
• First Posted: August 15, 2018
• Study Start: October 24, 2018
• Primary Completion: August 1, 2019
• Study Completion: October 1, 2019
• Last Updated: October 8, 2020

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)