Utilization of the BIOWAVE Device to Treat Overactive Bladder (OAB)

• ClinicalTrials.gov Identifier: NCT01848366
• Recruitment Status: Completed
• First Posted: May 7, 2013
• Results First Posted: December 7, 2016
• Last Update Posted: December 7, 2016
• Sponsor: Kenneth Peters, MD
• Information provided by (Responsible Party): Kenneth Peters, MD, William Beaumont Hospitals

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Overactive Bladder
• Intervention: Device: Biowave Treatment
• Enrollment: 8

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Biowave Treatment
Arm/Group Description	Twelve weekly treatments Biowave Treatment: Twelve weekly treatments
Period Title: Overall Study
Started	8
Completed	8
Not Completed	0

Baseline Characteristics

Arm/Group Title		Biowave Treatment
Arm/Group Description		Twelve weekly treatments Biowave Treatment: Twelve weekly treatments
Overall Number of Baseline Participants		8
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	8 participants
	<=18 years	0 0.0%
	Between 18 and 65 years	5 62.5%
	>=65 years	3 37.5%
Age, Continuous; Mean (Full Range); Unit of measure: Years
	Number Analyzed	8 participants
		56.6; (43 to 79)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	8 participants
	Female	8 100.0%
	Male	0 0.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	8 participants
		8

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Biowave Treatment
Arm/Group Description:	Twelve weekly treatments Biowave Treatment: Twelve weekly treatments
Overall Number of Participants Analyzed	8
Mean (Full Range); Unit of Measure: units on a scale
Bladder Symptoms	5.25; (4 to 7)
Urine Leakage with Activity	4; (4 to 4)
Urge Incontinence	4.6; (4 to 6)
Urinary Frequency	5.1; (4 to 7)
Urinary Urge	4.9; (4 to 7)
IC/BPS	4.3; (4 to 5)
Fecal Incontinence	4; (4 to 4)
Irritable Bowel Symptoms	4.25; (4 to 5)

Adverse Events

Time Frame	13 Weeks
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Biowave Treatment
Arm/Group Description	Twelve weekly treatments Biowave Treatment: Twelve weekly treatments
All-Cause Mortality
	Biowave Treatment
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events
	Biowave Treatment
	Affected / at Risk (%)
Total	0/8 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Biowave Treatment
	Affected / at Risk (%)
Total	0/8 (0.00%)

Limitations and Caveats

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

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Dr. Kenneth Peters
• Organization: William Beaumont Hospital
• Phone: 248-551-0387
• EMail: Kenneth.Peters@Beaumont.org

• Responsible Party: Kenneth Peters, MD, William Beaumont Hospitals
• ClinicalTrials.gov Identifier: NCT01848366
• Other Study ID Numbers: 2013-034
• First Submitted: May 2, 2013
• First Posted: May 7, 2013
• Results First Submitted: August 12, 2016
• Results First Posted: December 7, 2016
• Last Update Posted: December 7, 2016