N/A
N=23
Use of the Leva Incontinence System in Treating Bladder Incontinence.
Stress Urinary Incontinence
Bottom Line
View on ClinicalTrials.gov: NCT03536923 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Dec 2018
Primary outcome: Primary: Symptoms of Urinary Incontinence at Baseline and at 6 Weeks — 27.5; 1.1 score on a scale — p=0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Leva Incontinence System For Pelvic Floor Muscle strengthening (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Renovia, Inc.
- Primary completion
- Aug 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Symptoms of Urinary Incontinence at Baseline and at 6 Weeks |
27.5; 1.1 | 0.0001 sig |
| SECONDARY Condition-specific Quality of Life Assessment (IIQ-7) at Baseline and 6 Weeks. |
17.6; 0.2 | 0.0009 sig |
| SECONDARY Number of Participants for Different Categories of Patient Global Impression of Improvement (PGI-I) |
17; 4; 2; 0; 0 | — |
| SECONDARY Pelvic Floor Muscle Performance (Mean Maximum Duration of Voluntary Pelvic Floor Muscle Contraction) |
13; 187 | 0.0001 sig |
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.
Data sourced from ClinicalTrials.gov (NCT03536923). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.