A prospective, randomised, controlled, single-blind, multi-site clinical study employing Neuromuscular Electrical Stimulation (NMES) to stimulate the pelvic floor muscles of women suffering from stress urinary incontinence. Approximately one-hundred and eighty (180) female patients diagnosed with stress urinary incontinence will be enrolled in this study. All patients who are considered eligible to participate in the clinical study and give consent will be randomised to complete either a 12-week treatment programme with the Neurotech Vital Compact device or a 12-week treatment programme with the itouch Sure Pelvic Floor Exerciser. The 12-week treatment programme will be completed by the subjects at home with treatment with the device in accordance with the device Instructions for Use.
This is a prospective, randomised, controlled, single-blind, multi-site clinical study to be conducted in the United States of America (USA) employing Neuromuscular Electrical Stimulation (NMES) to stimulate the pelvic floor muscles of women suffering from stress urinary incontinence. Approximately one-hundred and eighty (180) female patients diagnosed with stress urinary incontinence will be enrolled in this study. All patients who are considered eligible to participate in the clinical study and give consent will be randomised to complete either a 12-week treatment programme with the Neurotech Vital Compact device or a 12-week treatment programme with the itouch Sure Pelvic Floor Exerciser. The 12-week treatment programme will be completed by the subjects at home with treatment with the device in accordance with the device Instructions for Use. Subjects included in the clinical study will be evaluated at screening, on enrolment into the study (baseline) and during the 12-week treatment programme at 4 and 12 weeks. A telephone call will be made at 1 week to check on the patient's progress. In addition, subjects will be evaluated at 26 week following their commencement of the treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
180
Neuromuscular electrical stimulation of the pelvic floor via an arrangement of external electrodes held in place by a garment.
Vaginal probe with electrodes designed to deliver electrical stimulation to the pelvic floor muscles.
Maricopa Integrated Health Systems
Phoenix, Arizona, United States
University of California Irvine Medical Center
Orange, California, United States
Hartford Hospital
Hartford, Connecticut, United States
Altus Research
Lake Worth, Florida, United States
University of South Florida Medical Center
Tampa, Florida, United States
Boston Clinical Trials
Boston, Massachusetts, United States
AccuMed Research Associates
Garden City, New York, United States
Lyndhurst Gynecological Associates
Winston-Salem, North Carolina, United States
Temple University
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
...and 2 more locations
Proportion of subjects who have achieved >50% improvement on the provocative pad weight test.
Subjects will complete an in-office 1 hour provocative pad test to determine volume of urine leaked during the test.
Time frame: 12 weeks
Between group comparison of mean change in urine leakage in a provocative pad weight test
Comparison of change on 1 hour pad test for Vital Compact vs. itouch Sure
Time frame: 12 Weeks
Within group comparison of mean change in urine leakage in the 1 hour pad weight test
Comparison of change in urine leakage for each treatment arm
Time frame: 12 weeks
Between group comparison of the mean improvement in the Incontinence Quality of Life Questionnaire (I-QOL) score
Comparison of change in I-QOL score between groups
Time frame: 12 weeks
Between group comparison of the proportion of subjects achieving dryness
The treatment arms will be compared regarding the proportion of subjects who leak less than 1 g at the 12 week 1 hour pad test.
Time frame: 12 weeks
Between group comparison of mean change in the number of incontinence episodes per day.
Between group comparison of mean change in the number of incontinence episodes per day using a 7-day voiding diary.
Time frame: 12 weeks
Between group mean change in urine leakage in the 24-hour pad weight test
Between group comparison of mean change, with respect to baseline, in urine leakage in the 24-hour pad weight test
Time frame: 12 weeks
Within Neurotech Vital Compact group estimate of mean change in urine leakage in the 24-hour pad weight
• Within Neurotech Vital Compact group estimate of mean change, with respect to baseline, in urine leakage in the 24-hour pad weight
Time frame: 12 weeks
Within Neurotech Vital Compact group estimate of mean improvement in Incontinence Quality of Life Questionnaire (I-QOL) score
Within Neurotech Vital Compact group estimate of mean improvement, with respect to baseline, in Incontinence Quality of Life Questionnaire (I-QOL) score
Time frame: 12 weeks
Between group comparison of mean change in the number of pads used/day
Between group comparison of mean change, with respect to baseline, in the number of pads used/day recorded using a 7-day voiding diary
Time frame: 12 weeks
Within Neurotech Vital Compact group estimate of mean change in the number of pads used/day
Within Neurotech Vital Compact group estimate of mean change, with respect to baseline, in the number of pads used/day recorded using a 7-day voiding diary
Time frame: 12 weeks
Between group comparison of the proportion of subjects achieving dryness at Week 12 (<1g on the provocative pad weight test)
Between group comparison of the proportion of subjects achieving dryness at Week 12 (\<1g on the provocative pad weight test)
Time frame: 12 weeks
Comparison of adverse events
Comparison between groups of adverse events reported throughout the study.
Time frame: 6 months
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