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OpenTrials
Completed

NCT Number: NCT03536923

Use of the Leva Incontinence System in Treating Bladder Incontinence.

This open-label proof-of-concept study is designed to evaluate the impact of the leva digital incontinence system on the treatment of stress and mixed urinary incontinence in women over a six week period. Subjects will participate in a 2.5 minute exercise program twice daily (performed at a clinic with therapist assistance 5x weekly, and at home once daily on weekdays and twice daily on weekends. Validated surveys (UDI-6, IIQ-7 and PGI-I) will be used to evaluate symptom relief. A battery of pelvic floor muscle exercises will be performed weekly to evaluate progress in muscle strengthening.

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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 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

New England Spine Center

Cambridge, Massachusetts, 02138, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects must be female.
  • Subjects must be capable of giving informed consent.
  • Subjects should be at least 18 years of age and less than 89 years of age
  • Subjects must have a diagnosis of or symptoms of predominant mild to moderate urinary incontinence based on the results of the completed urinary incontinence surveys.

Exclusion criteria

  • Absence of a vagina.
  • Positive drug or alcohol test at the screening visit.
  • Post-menopausal defined as absence of a period for over 12 months.
  • Pregnancy or being less than 12 months post-partum.
  • Greater than three vaginal deliveries or prior operative delivery (e.g. use of vacuum, forceps or abdominal pressure).
  • Symptoms of stage II or greater pelvic organ prolapse.
  • BMI >31 kg/m2.
  • Diagnosis of any neurological disorder.
  • Prior lower back or pelvic surgery, including prior surgery for stress urinary incontinence (SUI).
  • Prior pelvic radiation.
  • Current or recurrent vaginal infections (>three per year).
  • Painful bladder syndrome, active or chronic pelvic pain.
  • Concurrent Pelvic Floor Muscle Exercises (PFME) under a supervised therapeutic plan of care.
  • Previous supervised pelvic floor muscles rehabilitation in the past 12 months for the treatment for urinary incontinence or any other pelvic floor disorder.
  • Currently taking medication to treat incontinence.
  • Impaired cognitive function.
  • Unable to tolerate use of the leva device.

Treatment and study plan

Leva Incontinence System For Pelvic Floor Muscle strengthening

Device

The leva device is placed vaginally for 2.5 minutes twice daily, and pelvic floor muscle exercises are performed based on guidance from data sent from the device to their mobile phone.

Primary outcomes

  1. Symptoms of Urinary Incontinence at Baseline and at 6 Weeks

    Time frame: 6 weeks

    A validated, standardized questionnaire (the short form of the urogenital distress inventory, UDI-6) will be used to evaluate change in symptoms of urinary incontinence. Minimum score = 0, Maximum score = 100, lower scores indicate fewer symptoms.

Secondary outcomes

  1. Condition-specific Quality of Life Assessment (IIQ-7) at Baseline and 6 Weeks.

    Time frame: 6 weeks

    Condition specific quality of life as it is affected by urinary incontinence will be assessed using the Incontinence Impact Questionnaire (IIQ-7). Minimum value 0, Maximum value 100, lower scores indicate improvement.

  2. Number of Participants for Different Categories of Patient Global Impression of Improvement (PGI-I)

    Time frame: At 6 weeks

    Subject perception of improvement will be evaluated using the standardized survey Patient Global Impression of Improvement (PGI-I). Categories of improvement include: Very Much Better, Much Better, A Little Better, No Change, Worse(any degree).

  3. Pelvic Floor Muscle Performance (Mean Maximum Duration of Voluntary Pelvic Floor Muscle Contraction)

    Time frame: 6 weeks

    Change in pelvic floor muscle performance will be evaluated using muscle performance testing performed using the leva device. Subjects were asked to lift and squeeze pelvic floor muscles for as long as possible. The length of time a subject can "hold" the lift was recorded

Sponsors and collaborators

Lead sponsor

Renovia, Inc.

Industry

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 25, 2018
Registry last updated
Dec 12, 2018

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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