Trial Outcomes & Findings for Utilization of the BIOWAVE Device to Treat Overactive Bladder (NCT NCT01848366)

NCT ID: NCT01848366

Last Updated: 2016-12-07

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 8 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2016-12-07

Participant Flow

Participant milestones

Measure	Biowave Treatment Twelve weekly treatments Biowave Treatment: Twelve weekly treatments
Overall Study STARTED	8
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Utilization of the BIOWAVE Device to Treat Overactive Bladder

Baseline characteristics by cohort

Measure	Biowave Treatment n=8 Participants Twelve weekly treatments Biowave Treatment: Twelve weekly treatments
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Age, Continuous	56.6 years n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Biowave Treatment n=8 Participants Twelve weekly treatments Biowave Treatment: Twelve weekly treatments
Global Response Assessment (GRA) Bladder Symptoms	5.25 units on a scale Interval 4.0 to 7.0
Global Response Assessment (GRA) Urine Leakage with Activity	4 units on a scale Interval 4.0 to 4.0
Global Response Assessment (GRA) Urge Incontinence	4.6 units on a scale Interval 4.0 to 6.0
Global Response Assessment (GRA) Urinary Frequency	5.1 units on a scale Interval 4.0 to 7.0
Global Response Assessment (GRA) Urinary Urge	4.9 units on a scale Interval 4.0 to 7.0
Global Response Assessment (GRA) IC/BPS	4.3 units on a scale Interval 4.0 to 5.0
Global Response Assessment (GRA) Fecal Incontinence	4 units on a scale Interval 4.0 to 4.0
Global Response Assessment (GRA) Irritable Bowel Symptoms	4.25 units on a scale Interval 4.0 to 5.0

Adverse Events

Biowave Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Kenneth Peters

William Beaumont Hospital

Phone: 248-551-0387

Email: Kenneth.Peters@Beaumont.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place