Utilization of the BIOWAVE Device to Treat Overactive Bladder

NCT ID: NCT01848366

Last Updated: 2016-12-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2014-08-31

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.

Conditions

Overactive Bladder

Keywords

Frequency; urgency; incontinence

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Biowave Treatment

Twelve weekly treatments

Group Type: EXPERIMENTAL

Biowave Treatment

Intervention Type: DEVICE

Twelve weekly treatments

Interventions

Biowave Treatment

Twelve weekly treatments

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Kenneth Peters, MD

OTHER

Sponsor Role: lead

Responsible Party

Kenneth Peters, MD

Chairman, Department of Urology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Kenneth M Peters, MD

Role: PRINCIPAL_INVESTIGATOR

William Beaumont Hospitals

Locations

William Beaumont Hospital

Royal Oak, Michigan, United States

Countries

United States

Other Identifiers

2013-034

Identifier Type: -

Identifier Source: org_study_id