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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Leva Arm | Experimental | Subjects will use the leva device twice daily to perform pelvic floor muscle exercises |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Leva Incontinence System For Pelvic Floor Muscle strengthening | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria
Exclusion Criteria:
Subject must have a vagina
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| Name | Affiliation | Role |
|---|---|---|
| Robert Rosenberg, MD | New England Spine Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New England Spine Center | Cambridge | Massachusetts | 02138 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks |
|
Adverse event data was collected over a 6-week period
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper Respiratory Infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Common Cold |
This is a single-arm, proof of concept trial. As such it lacks a comparison arm, planned in future studies.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer, Dr. Samantha Pulliam | Renovia, Inc | 866-735-8424 | sjpulliam@renoviainc.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 14, 2017 | Dec 10, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| 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 |
| 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 |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Parity | Count of Participants | Participants |
|
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|
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| 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. | Posted | Mean | Standard Deviation | score on a scale | 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). | Posted | Count of Participants | Participants | 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 | Posted | Mean | Standard Deviation | seconds | 6 weeks |
|
|
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| 3 |
| 23 |
|
| Suspected urinary tract infection | Renal and urinary disorders | Non-systematic Assessment | Culture negative irritative voiding |
|
| Migraine Headache | Nervous system disorders | Non-systematic Assessment |
|
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| No Change |
|
| Worse, Any Degree |
|