Utilization of the BIOWAVE Device to Treat Overactive Bladder (OAB)

October 13, 2016 updated by: Kenneth Peters, MD

Biowave Overactive Bladder (OAB) Trial

Demonstrate a response to stimulation of the posterior tibial nerve using the Biowave device and a microneedle patch electrode in patients with overactive bladder symptoms. The investigators hypothesize that after at least 6 weekly treatments there will be modest improvements in overactive bladder symptoms trending toward more improvement.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Women 18 years old and over with a score of equal to or greater than 4 on the OAB-q short form for urgency and average daily urinary frequency equal to or greater than 10 times based on a 3-day voiding diary plus other inclusion criteria will be reviewed for possible enrollment in this study. Outcomes measured include Global Response Assessment (GRA) for overall bladder symptoms, a change in the 3-day voiding diary parameters and adverse events.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women >18 years of age
  • A score of > 4 on the OAB-q short form for urgency (question 1)
  • Average daily urinary frequency > 10 times based on a 3-day voiding diary
  • Self-reported bladder symptoms present > 3 months
  • Self-reported failed conservative care (i.e., dietary restriction, fluid restriction, bladder training, behavioral modification, pelvic muscle training, biofeedback, etc.)
  • Off all antimuscarinics for at least 2 weeks prior to enrollment
  • Capable of giving informed consent
  • Ambulatory and able to use a toilet independently, without difficulty
  • Capable and willing to follow all study-related procedures

Exclusion Criteria:

  • Pregnant as confirmed by urine pregnancy test, or plans to become pregnant during the study period
  • Neurogenic bladder
  • Botox® use in bladder or pelvic floor muscles in the past year
  • Pacemakers or implantable defibrillators
  • Primary complaint of stress urinary incontinence
  • Current urinary tract infection (UTI)
  • Current vaginal infection
  • Current use of InterStim®
  • Current use of Bion®
  • Previously been treated with Percutaneous Tibial Nerve Stimulation (PTNS)
  • Use of investigational drug/device therapy within the past 4 weeks.
  • Participating or have participated within the past 4 weeks in any clinical investigation involving or impacting gynecologic, urinary or renal function.
  • Deemed unsuitable for enrollment in study by the investigators based on subjects' history or physical examination (including skin disorders at the treatment site or peripheral neuropathy).
  • Subjects with nerve damage that would impact either percutaneous tibial nerve or pelvic floor function.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Biowave Treatment
Twelve weekly treatments
Device: Biowave Treatment
Twelve weekly treatments

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global Response Assessment (GRA)
Time Frame: 3 months
The GRA will be used to assess for changes in urinary condition and symptoms after 12 weekly BIOWAVE treatments. The GRA asks the participant to indicate how their condition or symptoms have changed compared to when they started the study. Eight questions addressed bladder symptoms, urine leakage related to activity, urine leakage associated with urge, urinary frequency, Interstitial Cystitis/Painful Bladder Syndrome (IC/BPS), fecal incontinence, and irritable bowel syndrome. Responses range from 1=Markedly Worse to 7=Markedly Improved.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kenneth Peters, MD

Investigators

  • Principal Investigator: Kenneth M Peters, MD, William Beaumont Hospitals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

May 2, 2013

First Submitted That Met QC Criteria

May 6, 2013

First Posted (Estimate)

May 7, 2013

Study Record Updates

Last Update Posted (Estimate)

December 7, 2016

Last Update Submitted That Met QC Criteria

October 13, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-034

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to share individual participant data

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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