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

• ClinicalTrials.gov Identifier: NCT00771264
• Recruitment Status: Completed
• First Posted: October 13, 2008
• Results First Posted: September 21, 2010
• Last Update Posted: April 18, 2012
• Sponsor: Uroplasty, Inc
• Information provided by (Responsible Party): Uroplasty, Inc

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Overactive Bladder	Device: Urgent PC Neuromodulation System	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 220 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Study Start Date: September 2008
• Actual Primary Completion Date: June 2009
• Actual Study Completion Date: June 2009

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Urgent PC	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).
No Intervention: Sham / Placebo

Outcome Measures

Primary Outcome Measures :

1. 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. [ Time Frame: 13 weeks ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, California

Gregory L. Davis, M.D., FACOG, Inc.

Chico, California, United States, 95928

United States, Connecticut

Greenwich Urological Associates, P.C.

Greenwich, Connecticut, United States, 06830

United States, Florida

Specialists in Urology

Naples, Florida, United States, 34102

United States, Michigan

Mercy Health Partners at the Lakes

Muskegon, Michigan, United States, 49444

Beaumont Hospital

Royal Oak, Michigan, United States, 48703

United States, Minnesota

Grand Rapids Women's Health DBA Female Pelvic Medicine & Urogynecology Institue of Michigan

Grand Rapids, Minnesota, United States, 49503

Uroplasty, Inc

Minnetonka, Minnesota, United States, 55343

Beaumont Hospital

Royal Oak, Minnesota, United States, 48073

United States, Nebraska

Urology Health Center, PC

Fremont, Nebraska, United States, 68025

United States, New York

Capital Region Urological Surgeons, PLLC

Albany, New York, United States, 12208

Central Missouri Women's Healthcare, LLC

White Plains, New York, United States, 10604

United States, North Carolina

Alliance Urology Specialists

Greensboro, North Carolina, United States, 27403

United States, Oklahoma

University of Oklahoma

Oklahoma City, Oklahoma, United States, 73104

United States, Virginia

Virginia Urology

Richmond, Virginia, United States, 23235

United States, Washington

Athena Urology

Issaquah, Washington, United States, 98027

Sponsors and Collaborators

Uroplasty, Inc

More Information

• Responsible Party: Uroplasty, Inc
• ClinicalTrials.gov Identifier: NCT00771264
• Other Study ID Numbers: UPC082008
• First Posted: October 13, 2008
• Results First Posted: September 21, 2010
• Last Update Posted: April 18, 2012
• Last Verified: April 2012

Keywords provided by Uroplasty, Inc:

Overactive Bladder

Additional relevant MeSH terms:

Urinary Bladder, Overactive; Urinary Bladder Diseases; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations