Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Use of the Leva Incontinence System in Treating Bladder Incontinence.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03536923
Recruitment Status : Completed
First Posted : May 25, 2018
Results First Posted : December 12, 2018
Last Update Posted : December 12, 2018
Sponsor:
Information provided by (Responsible Party):
Renovia, Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Stress Urinary Incontinence
Intervention Device: Leva Incontinence System For Pelvic Floor Muscle strengthening
Enrollment 23
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Leva Arm
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 23
Completed 23
Not Completed 0
Arm/Group Title Leva Arm
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 23
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants
<=18 years
0
   0.0%
Between 18 and 65 years
23
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 23 participants
42  (10.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants
Female
23
 100.0%
Male
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants
American Indian or Alaska Native
0
   0.0%
Asian
2
   8.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
3
  13.0%
White
17
  73.9%
More than one race
0
   0.0%
Unknown or Not Reported
1
   4.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 23 participants
23
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 23 participants
26  (4)
Parity  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants
Births=0
6
  26.1%
Births=1
5
  21.7%
Births=2
10
  43.5%
Births=3
2
   8.7%
1.Primary Outcome
Title Symptoms of Urinary Incontinence at Baseline and at 6 Weeks
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Leva Arm
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 23
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 27.5  (16.9)
Final (week 6) 1.1  (2.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Leva Arm
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
2.Secondary Outcome
Title Condition-specific Quality of Life Assessment (IIQ-7) at Baseline and 6 Weeks.
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Leva Arm
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 23
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 17.6  (21.6)
Final (week 6) 0.2  (1.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Leva Arm
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0009
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants for Different Categories of Patient Global Impression of Improvement (PGI-I)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Leva Arm
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 23
Measure Type: Count of Participants
Unit of Measure: Participants
Very Much Better
17
  73.9%
Much Better
4
  17.4%
A Little Better
2
   8.7%
No Change
0
   0.0%
Worse, Any Degree
0
   0.0%
4.Secondary Outcome
Title Pelvic Floor Muscle Performance (Mean Maximum Duration of Voluntary Pelvic Floor Muscle Contraction)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Leva Arm
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 23
Mean (Standard Deviation)
Unit of Measure: seconds
Baseline 13  (12)
Final (week 6) 187  (46)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Leva Arm
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Time Frame Adverse event data was collected over a 6-week period
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Leva Arm
Hide Arm/Group Description

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.

All-Cause Mortality
Leva Arm
Affected / at Risk (%)
Total   0/23 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Leva Arm
Affected / at Risk (%) # Events
Total   0/23 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Leva Arm
Affected / at Risk (%) # Events
Total   3/23 (13.04%)    
Nervous system disorders   
Migraine Headache *  1/23 (4.35%)  1
Renal and urinary disorders   
Suspected urinary tract infection * [1]  1/23 (4.35%)  1
Respiratory, thoracic and mediastinal disorders   
Upper Respiratory Infection * [2]  1/23 (4.35%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Culture negative irritative voiding
[2]
Common Cold
This is a single-arm, proof of concept trial. As such it lacks a comparison arm, planned in future studies.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Chief Medical Officer, Dr. Samantha Pulliam
Organization: Renovia, Inc
Phone: 866-735-8424
Responsible Party: Renovia, Inc.
ClinicalTrials.gov Identifier: NCT03536923     History of Changes
Other Study ID Numbers: REN-01
First Submitted: May 13, 2018
First Posted: May 25, 2018
Results First Submitted: August 10, 2018
Results First Posted: December 12, 2018
Last Update Posted: December 12, 2018