Back to resultsUtilization of the BIOWAVE Device to Treat Overactive Bladder (OAB)
Primary Purpose
Overactive Bladder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Biowave Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Overactive Bladder focused on measuring Frequency, urgency, incontinence
Eligibility Criteria
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.
Sites / Locations
- William Beaumont Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Biowave Treatment
Arm Description
Twelve weekly treatments
Outcomes
Primary Outcome Measures
Global Response Assessment (GRA)
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01848366
Brief Title
Utilization of the BIOWAVE Device to Treat Overactive Bladder
Acronym
OAB
Official Title
Biowave Overactive Bladder (OAB) Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kenneth Peters, MD
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder
Keywords
Frequency, urgency, incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Biowave Treatment
Arm Type
Experimental
Arm Description
Twelve weekly treatments
Intervention Type
Device
Intervention Name(s)
Biowave Treatment
Intervention Description
Twelve weekly treatments
Primary Outcome Measure Information:
Title
Global Response Assessment (GRA)
Description
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.
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth M Peters, MD
Organizational Affiliation
William Beaumont Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share individual participant data
Learn more about this trial
Utilization of the BIOWAVE Device to Treat Overactive Bladder
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