Trial Outcomes & Findings for Use of the Leva Incontinence System in Treating Bladder Incontinence. (NCT NCT03536923)
NCT ID: NCT03536923
Last Updated: 2018-12-12
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
23 participants
Primary outcome timeframe
6 weeks
Results posted on
2018-12-12
Participant Flow
Participant milestones
| Measure |
Leva Arm
Subjects will use the leva device twice daily to perform pelvic floor muscle exercises
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.
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|---|---|
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Overall Study
STARTED
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23
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Overall Study
COMPLETED
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23
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Use of the Leva Incontinence System in Treating Bladder Incontinence.
Baseline characteristics by cohort
| Measure |
Leva Arm
n=23 Participants
Subjects will use the leva device twice daily to perform pelvic floor muscle exercises
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. Subjects completed one daily exercise under direct supervision 5x weekly. The remaining daily exercise on weekdays, and twice daily on weekends, were performed at home at the subject's discretion.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
|
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Age, Categorical
Between 18 and 65 years
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23 Participants
n=5 Participants
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Age, Categorical
>=65 years
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0 Participants
n=5 Participants
|
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Age, Continuous
|
42 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
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Sex: Female, Male
Female
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23 Participants
n=5 Participants
|
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Sex: Female, Male
Male
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
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Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Unknown or Not Reported
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1 Participants
n=5 Participants
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Region of Enrollment
United States
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23 participants
n=5 Participants
|
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BMI
|
26 kg/m^2
STANDARD_DEVIATION 4 • n=5 Participants
|
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Parity
Births=0
|
6 Participants
n=5 Participants
|
|
Parity
Births=1
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5 Participants
n=5 Participants
|
|
Parity
Births=2
|
10 Participants
n=5 Participants
|
|
Parity
Births=3
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeksA 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.
Outcome measures
| Measure |
Leva Arm
n=23 Participants
Subjects will use the leva device twice daily to perform pelvic floor muscle exercises
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. Subjects completed one daily exercise under direct supervision 5x weekly. The remaining daily exercise on weekdays, and twice daily on weekends, were performed at home at the subject's discretion.
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|---|---|
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Symptoms of Urinary Incontinence at Baseline and at 6 Weeks
Baseline
|
27.5 score on a scale
Standard Deviation 16.9
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Symptoms of Urinary Incontinence at Baseline and at 6 Weeks
Final (week 6)
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1.1 score on a scale
Standard Deviation 2.9
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SECONDARY outcome
Timeframe: 6 weeksCondition 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.
Outcome measures
| Measure |
Leva Arm
n=23 Participants
Subjects will use the leva device twice daily to perform pelvic floor muscle exercises
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. Subjects completed one daily exercise under direct supervision 5x weekly. The remaining daily exercise on weekdays, and twice daily on weekends, were performed at home at the subject's discretion.
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|---|---|
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Condition-specific Quality of Life Assessment (IIQ-7) at Baseline and 6 Weeks.
Baseline
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17.6 score on a scale
Standard Deviation 21.6
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Condition-specific Quality of Life Assessment (IIQ-7) at Baseline and 6 Weeks.
Final (week 6)
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0.2 score on a scale
Standard Deviation 1.0
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SECONDARY outcome
Timeframe: At 6 weeksSubject 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).
Outcome measures
| Measure |
Leva Arm
n=23 Participants
Subjects will use the leva device twice daily to perform pelvic floor muscle exercises
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. Subjects completed one daily exercise under direct supervision 5x weekly. The remaining daily exercise on weekdays, and twice daily on weekends, were performed at home at the subject's discretion.
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|---|---|
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Number of Participants for Different Categories of Patient Global Impression of Improvement (PGI-I)
Very Much Better
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17 Participants
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Number of Participants for Different Categories of Patient Global Impression of Improvement (PGI-I)
Much Better
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4 Participants
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Number of Participants for Different Categories of Patient Global Impression of Improvement (PGI-I)
A Little Better
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2 Participants
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Number of Participants for Different Categories of Patient Global Impression of Improvement (PGI-I)
No Change
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0 Participants
|
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Number of Participants for Different Categories of Patient Global Impression of Improvement (PGI-I)
Worse, Any Degree
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0 Participants
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SECONDARY outcome
Timeframe: 6 weeksChange 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
Outcome measures
| Measure |
Leva Arm
n=23 Participants
Subjects will use the leva device twice daily to perform pelvic floor muscle exercises
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. Subjects completed one daily exercise under direct supervision 5x weekly. The remaining daily exercise on weekdays, and twice daily on weekends, were performed at home at the subject's discretion.
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|---|---|
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Pelvic Floor Muscle Performance (Mean Maximum Duration of Voluntary Pelvic Floor Muscle Contraction)
Baseline
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13 seconds
Standard Deviation 12
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Pelvic Floor Muscle Performance (Mean Maximum Duration of Voluntary Pelvic Floor Muscle Contraction)
Final (week 6)
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187 seconds
Standard Deviation 46
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Adverse Events
Leva Arm
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Leva Arm
n=23 participants at risk
Subjects will use the leva device twice daily to perform pelvic floor muscle exercises
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. Subjects completed one daily exercise under direct supervision 5x weekly. The remaining daily exercise on weekdays, and twice daily on weekends, were performed at home at the subject's discretion.
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|---|---|
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Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
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4.3%
1/23 • Number of events 1 • Adverse event data was collected over a 6-week period
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Renal and urinary disorders
Suspected urinary tract infection
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4.3%
1/23 • Number of events 1 • Adverse event data was collected over a 6-week period
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Nervous system disorders
Migraine Headache
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4.3%
1/23 • Number of events 1 • Adverse event data was collected over a 6-week period
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Additional Information
Chief Medical Officer, Dr. Samantha Pulliam
Renovia, Inc
Phone: 866-735-8424
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place