Safety and Effectiveness of a Non-invasive Neuromodulation Device on Urgency Urinary Incontinence in Overactive Bladder

NACompletedINTERVENTIONAL
Enrollment

163

Participants

Timeline

Start Date

June 30, 2011

Primary Completion Date

January 31, 2013

Study Completion Date

December 31, 2013

Conditions
Overactive Bladder
Interventions
DEVICE

(VERV™ System)

Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete.

DEVICE

Sham version of (VERV™ System)

Inactive (sham) electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete.

Trial Locations (14)

10016

University Urology Associates, New York

20037

GW Medical Faculty Associates, Washington D.C.

27403

Alliance Urology Specialists, P.A., Greensboro

28207

McKay Urology, Charlotte

29572

Carolina Urologic Research, Myrtle Beach

33060

Urology Center of Florida, Pompano Beach

34102

Specialists in Urology, Naples

47130

1st Urology, PSC dba Metropolitan Urology, Jeffersonville

48073

William Beaumont Hospital, Royal Oak

53226

Wheaton Franciscan Medical Group - Milwaukee Urogynecology, Wauwatosa

60453

Women's Health Institute of Illlinois, Ltd, Oak Lawn

92562

Tri Valley Urology Medical Group, Murrieta

98043

Integrity Medical Research, Mountlake Terrace

85712-5803

Arizona Urologic Specialists, Tucson

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novella Clinical

OTHER

collaborator

Data & Inference, Inc.

INDUSTRY

lead

Ethicon Endo-Surgery

INDUSTRY

NCT01369485 - Safety and Effectiveness of a Non-invasive Neuromodulation Device on Urgency Urinary Incontinence in Overactive Bladder | Biotech Hunter | Biotech Hunter