Study of Urgent PC Versus Sham Effectiveness in Treatment of Overactive Bladder Symptoms

Overactive Bladder Clinical Trial

— SUmiT  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00771264
• Other study ID #: UPC082008
• Status: Completed
• Phase: Phase 4
• First received: October 9, 2008
• Last updated: April 13, 2012
• Start date: September 2008
• Est. completion date: June 2009

Study information

• Verified date: April 2012
• Source: Uroplasty, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to demonstrate superiority of percutaneous posterior tibial nerve stimulation (PTNS) therapy compared to sham therapy for the treatment of patients with overall bladder (OAB) symptoms.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Women and men >18 years of age

• A score of > 4 on the OAB-q short form for urgency (question 1)

• Average urinary frequency > 10 times in one 24 hour day 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

• Current use of TENS in the pelvic region, back or legs

• Previously been treated with 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 bleeding disorders or anticoagulant medications, and peripheral neuropathy)

• Subjects with nerve damage that would impact either percutaneous tibial nerve or pelvic floor function

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Device:
• Urgent PC Neuromodulation System
The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).

Locations

Country	Name	City	State
United States	Capital Region Urological Surgeons, PLLC	Albany	New York
United States	Gregory L. Davis, M.D., FACOG, Inc.	Chico	California
United States	Urology Health Center, PC	Fremont	Nebraska
United States	Grand Rapids Women's Health DBA Female Pelvic Medicine & Urogynecology Institue of Michigan	Grand Rapids	Minnesota
United States	Alliance Urology Specialists	Greensboro	North Carolina
United States	Greenwich Urological Associates, P.C.	Greenwich	Connecticut
United States	Athena Urology	Issaquah	Washington
United States	Uroplasty, Inc	Minnetonka	Minnesota
United States	Mercy Health Partners at the Lakes	Muskegon	Michigan
United States	Specialists in Urology	Naples	Florida
United States	University of Oklahoma	Oklahoma City	Oklahoma
United States	Virginia Urology	Richmond	Virginia
United States	Beaumont Hospital	Royal Oak	Michigan
United States	Beaumont Hospital	Royal Oak	Minnesota
United States	Central Missouri Women's Healthcare, LLC	White Plains	New York

Sponsors (1)

Lead Sponsor	Collaborator
Uroplasty, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Global Response Assessment (GRA) for Overall Bladder Symptoms to Compare the Proportion of Subjects Reporting "Moderately" or "Markedly Improved" Responses on the GRA After 12 Interventions of Randomized Therapy, in an Intent to Treat Analysis.	A responder was defined as reporting bladder symptoms as moderately or markedly improved on a 7-level GRA at week 13 after completing 12, 30-minute, consecutive weekly intervention sessions.	13 weeks	No