Stress Urinary Incontinence
Conditions
Keywords
Female
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.
Interventions
DEVICELeva 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.
Sponsors
Renovia, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 89 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptoms of Urinary Incontinence at Baseline and at 6 Weeks | 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
| Measure | Time frame | Description |
|---|---|---|
| Condition-specific Quality of Life Assessment (IIQ-7) at Baseline and 6 Weeks. | 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. |
| Number of Participants for Different Categories of Patient Global Impression of Improvement (PGI-I) | 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). |
| Pelvic Floor Muscle Performance (Mean Maximum Duration of Voluntary Pelvic Floor Muscle Contraction) | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. 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. | 23 |
| Total | 23 |
Baseline characteristics
| Characteristic | Leva Arm |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants |
| Age, Continuous | 42 years STANDARD_DEVIATION 10.7 |
| BMI | 26 kg/m^2 STANDARD_DEVIATION 4 |
| Parity Births=0 | 6 Participants |
| Parity Births=1 | 5 Participants |
| Parity Births=2 | 10 Participants |
| Parity Births=3 | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 17 Participants |
| Region of Enrollment United States | 23 participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 23 |
| other Total, other adverse events | 3 / 23 |
| serious Total, serious adverse events | 0 / 23 |
Outcome results
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.
Time frame: 6 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Leva Arm | Symptoms of Urinary Incontinence at Baseline and at 6 Weeks | Final (week 6) | 1.1 score on a scale | Standard Deviation 2.9 |
| Leva Arm | Symptoms of Urinary Incontinence at Baseline and at 6 Weeks | Baseline | 27.5 score on a scale | Standard Deviation 16.9 |
p-value: 0.0001t-test, 1 sided
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.
Time frame: 6 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Leva Arm | Condition-specific Quality of Life Assessment (IIQ-7) at Baseline and 6 Weeks. | Baseline | 17.6 score on a scale | Standard Deviation 21.6 |
| Leva Arm | Condition-specific Quality of Life Assessment (IIQ-7) at Baseline and 6 Weeks. | Final (week 6) | 0.2 score on a scale | Standard Deviation 1 |
p-value: 0.0009t-test, 1 sided
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).
Time frame: At 6 weeks
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Leva Arm | Number of Participants for Different Categories of Patient Global Impression of Improvement (PGI-I) | Very Much Better | 17 Participants |
| Leva Arm | Number of Participants for Different Categories of Patient Global Impression of Improvement (PGI-I) | Much Better | 4 Participants |
| Leva Arm | Number of Participants for Different Categories of Patient Global Impression of Improvement (PGI-I) | A Little Better | 2 Participants |
| Leva Arm | Number of Participants for Different Categories of Patient Global Impression of Improvement (PGI-I) | No Change | 0 Participants |
| Leva Arm | Number of Participants for Different Categories of Patient Global Impression of Improvement (PGI-I) | Worse, Any Degree | 0 Participants |
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
Time frame: 6 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Leva Arm | Pelvic Floor Muscle Performance (Mean Maximum Duration of Voluntary Pelvic Floor Muscle Contraction) | Baseline | 13 seconds | Standard Deviation 12 |
| Leva Arm | Pelvic Floor Muscle Performance (Mean Maximum Duration of Voluntary Pelvic Floor Muscle Contraction) | Final (week 6) | 187 seconds | Standard Deviation 46 |
p-value: 0.0001t-test, 1 sided