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Completed

NCT Number: NCT03632447

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

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.

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Key information

Conditions

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

Age range

18 year–89 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Leva

Device

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

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.

Primary outcomes

  1. PGI-I

    Time frame: 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."

  2. UDI-6

    Time frame: 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 outcomes

  1. 3-day voiding diary

    Time frame: 8 weeks after randomization

    An objective evaluation of urinary incontinence

Other outcomes

  1. Adherence

    Time frame: 8 weeks, 6 months, 12 months

    Adherence to the exercise regimen will be evaluated

Sponsors and collaborators

Lead sponsor

Renovia, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 15, 2018
Registry last updated
Oct 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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