Use of the Leva Incontinence System in Treating Bladder Incontinence.

Stress Urinary Incontinence Clinical Trial

Official title:

Use of the Leva Incontinence System in Treating Bladder Incontinence.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03536923
• Other study ID #: REN-01
• Status: Completed
• Phase: N/A
• Start date: April 10, 2017
• Est. completion date: October 20, 2017

Study information

• Verified date: December 2018
• Source: Renovia, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: October 20, 2017
• Est. primary completion date: August 12, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Device:
• Leva Incontinence System For Pelvic Floor Muscle strengthening
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.

Locations

Country	Name	City	State
United States	New England Spine Center	Cambridge	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Renovia, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptoms of Urinary Incontinence at Baseline and at 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.	6 weeks
Secondary	Condition-specific Quality of Life Assessment (IIQ-7) at Baseline and 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.	6 weeks
Secondary	Number of Participants for Different Categories of Patient Global Impression of Improvement (PGI-I)	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).	At 6 weeks
Secondary	Pelvic Floor Muscle Performance (Mean Maximum Duration of Voluntary Pelvic Floor Muscle Contraction)	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	6 weeks