Neurotech Vital Compact Versus Itouch Sure Pelvic Floor Exerciser US

Not Applicable

Completed

• Conditions: Stress Urinary Incontinence
• Interventions: Device: Neurotech Vital Compact; Device: itouch Sure Pelvic Floor Exerciser

• Registration Number: NCT02423005
• Lead Sponsor: Atlantic Therapeutics

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-17
• Study First Submitted QC: 2015-04-21
• Study First Posted: 2015-04-22
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-01
• Last Update Posted: 2018-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 180

Inclusion Criteria

1. Subjects who are female and at least 18 years of age, and not more than 65 years of age.
2. Subjects who have signed the informed consent form prior to any study related activity.
3. Subjects who have previously tried and failed to improve their condition using Kegel exercises.
4. Subjects who have been clinically diagnosed with stress urinary incontinence and demonstrate a greater than or equal to 3g urine leakage and a less than or equal to 90g urine leakage (>3g and < 90g) following a bladder-filling protocol and then a standardised stress test (provocative pad weight test) at the baseline assessment.
5. Subjects who score 9 or less (<9) out of 18 for the Urge Incontinence Questions and are confirmed as having predominant stress urinary incontinence on the Medical, Epidemiologic and Social Aspects of Aging Urinary Incontinence (MESA) Questionnaire completed at the screening assessment.
6. Subjects with a Body Mass Index of ≤ 35 kg/m2.
7. Subjects of child-bearing potential who are using a highly effective contraceptive method (established use of oral, injected, implanted hormonal method of contraception or barrier method of contraception with spermicide).
8. Subjects who are willing not to seek any other treatment for stress incontinence during the study period.
9. Subjects who are able to give voluntary, written informed consent to participate in this study and from whom consent has been obtained.
10. Subjects who are able to understand this study and are willing to complete all the study assessments.

Exclusion Criteria

1. Subjects who have an existing medical condition that would compromise their participation in the study, e.g. reduced sensory perception in the contact area of the stimulation electrodes; scars or vaginal tissue wounds, lesions or inflamed/infected areas in the contact area of the stimulation electrodes; vaginal bleeding between menstrual periods; uncontrolled diabetes.
2. Subjects who have a physical condition that would make them unable to perform the study procedures, e.g. pelvic or hip surgery within the past 6 weeks.
3. Subjects who have been diagnosed with Chronic Obstructive Pulmonary Disease (COPD).
4. Subjects with a history of an underlying neurological condition, e.g. Multiple Sclerosis, Parkinson's disease, epilepsy.
5. Subjects with any bladder abnormality that would affect the urinary flow through the lower urinary tract including signs or symptoms of an active urinary tract infection, abnormal bladder capacity (e.g., >300 cc), post void residual volume >200 cc, spastic bladder, vesico-ureteral reflux or bladder stones.
6. Subjects with a blood clotting disorder or who are taking anti-coagulant medications.
7. Subjects who have previously had any uro-gynaecological related surgery that would affect the pelvic floor muscles or urinary flow through the urethra (excluding hysterectomy).
8. Subjects who have previously had pelvic floor radiation.
9. Subjects who have previously been treated for stress incontinence with injectable bulking agents and/or vaginal probes within the past 6 months.
10. Subjects with a clinical diagnosis of prolapse greater than Stage 2.
11. Subjects who are pregnant or could be pregnant.
12. Subjects who are less than 6 months post-partum or who are lactating.
13. Subjects who have any conductive intra-uterine devices or metal implants in the pelvic area, including hip and lumbar spine.
14. Subjects with pelvic pain or fibromyalgia or paravaginal defect.
15. Subjects with an active implanted medical device (i.e. pacemaker, insulin pump etc.) or conditions that may be adversely affected by electrical stimulation (e.g. cardiac arrhythmias).
16. Subjects with a current or active history of pelvic cancer and/or subjects with a life expectancy of less than 12 months.
17. Subjects who are currently involved in any injury litigation claims.
18. Subjects who have participated in a clinical study in the last 3 months or any previous clinical study with Bio-Medical Research Ltd.
19. Subjects who have been committed to an institution by virtue of an order issued either by the courts or by an authority.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neurotech Vital Compact	Neurotech Vital Compact	The Neurotech Vital Compact will be used by subjects with Stress Urinary Incontinence 5 days per week for 30 minutes per session for 12 weeks followed by 14 weeks of Kegel exercises.
itouch Sure Pelvic Floor Exerciser	itouch Sure Pelvic Floor Exerciser	The itouch Sure Pelvic Floor Exerciser will be used by subjects with Stress Urinary Incontinence 7 days per week for 20 minutes per session for 12 weeks followed by 14 weeks of Kegel exercises.

Primary Outcome Measures

Name	Time	Method
Proportion of subjects who have achieved >50% improvement on the provocative pad weight test.	12 weeks	Subjects will complete an in-office 1 hour provocative pad test to determine volume of urine leaked during the test.

Secondary Outcome Measures

Name	Time	Method
Within group comparison of mean change in urine leakage in the 1 hour pad weight test	12 weeks	Comparison of change in urine leakage for each treatment arm
Between group comparison of the proportion of subjects achieving dryness at Week 12 (<1g on the provocative pad weight test)	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 mean change in urine leakage in a provocative pad weight test	12 Weeks	Comparison of change on 1 hour pad test for Vital Compact vs. itouch Sure
Between group mean change in urine leakage in the 24-hour pad weight test	12 weeks	Between group comparison of mean change, with respect to baseline, in urine leakage in the 24-hour pad weight test
Within Neurotech Vital Compact group estimate of mean change in the number of pads used/day	12 weeks	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
Within Neurotech Vital Compact group estimate of mean improvement in Incontinence Quality of Life Questionnaire (I-QOL) score	12 weeks	Within Neurotech Vital Compact group estimate of mean improvement, with respect to baseline, in Incontinence Quality of Life Questionnaire (I-QOL) score
Comparison of adverse events	6 months	Comparison between groups of adverse events reported throughout the study.
Between group comparison of the mean improvement in the Incontinence Quality of Life Questionnaire (I-QOL) score	12 weeks	Comparison of change in I-QOL score between groups
Between group comparison of the proportion of subjects achieving dryness	12 weeks	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.
Between group comparison of mean change in the number of incontinence episodes per day.	12 weeks	Between group comparison of mean change in the number of incontinence episodes per day using a 7-day voiding diary.
Within Neurotech Vital Compact group estimate of mean change in urine leakage in the 24-hour pad weight	12 weeks	• Within Neurotech Vital Compact group estimate of mean change, with respect to baseline, in urine leakage in the 24-hour pad weight
Between group comparison of mean change in the number of pads used/day	12 weeks	Between group comparison of mean change, with respect to baseline, in the number of pads used/day recorded using a 7-day voiding diary

Trial Locations

Locations (12)

Hartford Hospital; 🇺🇸 Hartford, Connecticut, United States

Boston Clinical Trials; 🇺🇸 Boston, Massachusetts, United States

University of California Irvine Medical Center; 🇺🇸 Orange, California, United States

University of South Florida Medical Center; 🇺🇸 Tampa, Florida, United States

Altus Research; 🇺🇸 Lake Worth, Florida, 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

Maricopa Integrated Health Systems; 🇺🇸 Phoenix, Arizona, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

The Jackson Clinic; 🇺🇸 Jackson, Tennessee, United States

Renaissance Health & Surgical Associates; 🇺🇸 South Pittsburg, Tennessee, United States