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Clinical Trial to Study a Non-invasive Neurostimulation Device on Urgency (Urinary) Incontinence Overactive Bladder (OAB)

NCT01125722 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2012-12-17

Study results available
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Summary

The purpose of this study is to determine whether the non-invasive neurostimulation patch is effective in the treatment of urgency, frequency and urge (urinary) incontinence.

Conditions

Interventions

DEVICE

Non-invasive neurostimulation device

Active electrode patches are worn for 4 weeks, one per week, during the treatment phase of the study. The patch is placed by the investigator.

DEVICE

Non-invasive neurostimulation device

Active electrode patches are worn for 4 weeks, one per week, during the treatment phase of the study. The patch is placed by the subject.

Sponsors & Collaborators

  • Novella Clinical

    collaborator OTHER

  • Data & Inference, Inc.

    collaborator INDUSTRY

  • Ethicon Endo-Surgery

    lead INDUSTRY

Principal Investigators

  • Ashwani Monga, BM BS, MRCOG · Princess Anne Hospital, Southampton, UK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2011-02-28
Completion
2011-03-31

Countries

  • United States
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01125722 on ClinicalTrials.gov