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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03632447
Other study ID # REN-05
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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