Clinical trial NCT03536923: Use of the Leva Incontinence System in Treating Bladder Incontinence.
Official title: Use of the Leva Incontinence System in Treating Bladder Incontinence.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Keywords: Female
Lead sponsor: Renovia, Inc.
Sponsor class: INDUSTRY
First posted: 2018-05-25
Enrollment: 23
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Symptoms of Urinary Incontinence at Baseline and at 6 Weeks
timeFrame: 6 weeks
Secondary outcomes:
measure: Condition-specific Quality of Life Assessment (IIQ-7) at Baseline and 6 Weeks.
timeFrame: 6 weeks
measure: Number of Participants for Different Categories of Patient Global Impression of Improvement (PGI-I)
timeFrame: At 6 weeks
measure: Pelvic Floor Muscle Performance (Mean Maximum Duration of Voluntary Pelvic Floor Muscle Contraction)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: New England Spine Center
state: Massachusetts
Study officials:
affiliation: New England Spine Center
name: Robert Rosenberg, MD
role: PRINCIPAL_INVESTIGATOR
References: