NCT02423005

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2015

Typical duration for not_applicable

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

April 17, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 22, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

February 5, 2018

Status Verified

February 1, 2018

Enrollment Period

2 years

First QC Date

April 17, 2015

Last Update Submit

February 1, 2018

Conditions

Stress Urinary Incontinence

Keywords

Stress urinary incontinenceNeurotech Vital Compact1h Provacative Pad TestNeuroelectrical Muscle Stimulation (NEMS)

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 weeks

Secondary Outcomes (12)

  • Between group comparison of mean change in urine leakage in a provocative pad weight test

    12 Weeks

  • Within group comparison of mean change in urine leakage in the 1 hour pad weight test

    12 weeks

  • Between group comparison of the mean improvement in the Incontinence Quality of Life Questionnaire (I-QOL) score

    12 weeks

  • Between group comparison of the proportion of subjects achieving dryness

    12 weeks

  • Between group comparison of mean change in the number of incontinence episodes per day.

    12 weeks

  • +7 more secondary outcomes

Study Arms (2)

Neurotech Vital Compact

EXPERIMENTAL

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.

Device: Neurotech Vital Compact

itouch Sure Pelvic Floor Exerciser

ACTIVE COMPARATOR

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.

Device: itouch Sure Pelvic Floor Exerciser

Interventions

Neurotech Vital CompactDEVICE

Neuromuscular electrical stimulation of the pelvic floor via an arrangement of external electrodes held in place by a garment.

Neurotech Vital Compact
itouch Sure Pelvic Floor ExerciserDEVICE

Vaginal probe with electrodes designed to deliver electrical stimulation to the pelvic floor muscles.

Also known as: EmbaGYN
itouch Sure Pelvic Floor Exerciser

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects who are female and at least 18 years of age, and not more than 65 years of age.
  • Subjects who have signed the informed consent form prior to any study related activity.
  • Subjects who have previously tried and failed to improve their condition using Kegel exercises.
  • 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.
  • 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.
  • Subjects with a Body Mass Index of ≤ 35 kg/m2.
  • 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).
  • Subjects who are willing not to seek any other treatment for stress incontinence during the study period.
  • Subjects who are able to give voluntary, written informed consent to participate in this study and from whom consent has been obtained.
  • Subjects who are able to understand this study and are willing to complete all the study assessments.

You may not qualify if:

  • 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.
  • 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.
  • Subjects who have been diagnosed with Chronic Obstructive Pulmonary Disease (COPD).
  • Subjects with a history of an underlying neurological condition, e.g. Multiple Sclerosis, Parkinson's disease, epilepsy.
  • 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.
  • Subjects with a blood clotting disorder or who are taking anti-coagulant medications.
  • 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).
  • Subjects who have previously had pelvic floor radiation.
  • Subjects who have previously been treated for stress incontinence with injectable bulking agents and/or vaginal probes within the past 6 months.
  • Subjects with a clinical diagnosis of prolapse greater than Stage 2.
  • Subjects who are pregnant or could be pregnant.
  • Subjects who are less than 6 months post-partum or who are lactating.
  • Subjects who have any conductive intra-uterine devices or metal implants in the pelvic area, including hip and lumbar spine.
  • Subjects with pelvic pain or fibromyalgia or paravaginal defect.
  • 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).
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Maricopa Integrated Health Systems

Phoenix, Arizona, 85008, United States

Location

University of California Irvine Medical Center

Orange, California, 92868, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

Altus Research

Lake Worth, Florida, 33461, United States

Location

University of South Florida Medical Center

Tampa, Florida, 33606, United States

Location

Boston Clinical Trials

Boston, Massachusetts, 02131, United States

Location

AccuMed Research Associates

Garden City, New York, 11530, United States

Location

Lyndhurst Gynecological Associates

Winston-Salem, North Carolina, 27103, United States

Location

Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

The Jackson Clinic

Jackson, Tennessee, 38305, United States

Location

Renaissance Health & Surgical Associates

South Pittsburg, Tennessee, 37380, United States

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Conor Minogue, PhD

    Bio-Medical Research, Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2015

First Posted

April 22, 2015

Study Start

April 1, 2015

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

February 5, 2018

Record last verified: 2018-02

Locations

US(12)