Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-31 @ 3:58 PM
Study NCT ID:
NCT02423005
Status:
COMPLETED
Last Update Posted:
2018-02-05
First Post:
2015-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neurotech Vital Compact Versus Itouch Sure Pelvic Floor Exerciser US
Sponsor:
Atlantic Therapeutics
Organization:
Study Overview
Official Title:
A Single-blind, Multi-centre, Randomised, Controlled, Non-inferiority, Clinical Study to Assess the Safety and Performance of the Neurotech Vital Compact Device Compared to the Itouch Sure Pelvic Floor Exerciser for the Treatment of Stress Urinary Incontinence in Female Patients
Status:
COMPLETED
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: