Biowave Overactive Bladder Trial

Overactive Bladder Clinical Trial

— OAB  

Official title:

Biowave Overactive Bladder (OAB) Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01848366
• Other study ID #: 2013-034
• Status: Active, not recruiting
• Phase: N/A
• First received: May 2, 2013
• Last updated: October 13, 2015
• Start date: May 2013
• Est. completion date: December 2015

Study information

• Verified date: October 2015
• Source: William Beaumont Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Device:
• Biowave Treatment
Six weekly treatments

Locations

Country	Name	City	State
United States	William Beaumont Hospital	Royal Oak	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Kenneth Peters, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global Response Assessment (GRA)	The GRA will be used to compare the proportion of subjects reporting 'moderately' or 'markedly improved' responses on the GRA after 12 weekly treatments.	3 months	No