Utilization of the BIOWAVE Device to Treat Overactive Bladder

NCT01848366 | Completed Results

• 1 other identifier: 2013-034
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Overactive Bladder

Keywords

Frequency; urgency; incontinence

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Study Arms (1)

Biowave Treatment

EXPERIMENTAL

Twelve weekly treatments

Device: Biowave Treatment

Interventions

Biowave Treatment DEVICE

Twelve weekly treatments

Biowave Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kenneth Peters, MD: lead

Study Sites (1)

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Due to the small number of subjects enrolled, the results of this preliminary study are limited and not generalizable.

Results Point of Contact

• Title: Dr. Kenneth Peters
• Organization: William Beaumont Hospital

Kenneth.Peters@Beaumont.org

248-551-0387

Study Officials

• Kenneth M Peters, MD

  Corewell Health East

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chairman, Department of Urology

Study Record Dates

• First Submitted: May 2, 2013
• First Posted: May 7, 2013
• Study Start: May 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: December 7, 2016
• Results First Posted: December 7, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)