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

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.

Study Overview

• Status: Completed
• Conditions: Overactive Bladder
• Intervention / Treatment: Device: Urgent PC Neuromodulation System

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Chico, California, United States, 95928
      • Gregory L. Davis, M.D., FACOG, Inc.
  • Connecticut
    • Greenwich, Connecticut, United States, 06830
      • Greenwich Urological Associates, P.C.
  • Florida
    • Naples, Florida, United States, 34102
      • Specialists in Urology
  • Michigan
    • Muskegon, Michigan, United States, 49444
      • Mercy Health Partners at the Lakes
    • Royal Oak, Michigan, United States, 48703
      • Beaumont Hospital
  • Minnesota
    • Grand Rapids, Minnesota, United States, 49503
      • Grand Rapids Women's Health DBA Female Pelvic Medicine & Urogynecology Institue of Michigan
    • Minnetonka, Minnesota, United States, 55343
      • Uroplasty, Inc
    • Royal Oak, Minnesota, United States, 48073
      • Beaumont Hospital
  • Nebraska
    • Fremont, Nebraska, United States, 68025
      • Urology Health Center, PC
  • New York
    • Albany, New York, United States, 12208
      • Capital Region Urological Surgeons, PLLC
    • White Plains, New York, United States, 10604
      • Central Missouri Women's Healthcare, LLC
  • North Carolina
    • Greensboro, North Carolina, United States, 27403
      • Alliance Urology Specialists
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma
  • Virginia
    • Richmond, Virginia, United States, 23235
      • Virginia Urology
  • Washington
    • Issaquah, Washington, United States, 98027
      • Athena Urology

Participation Criteria

Eligibility Criteria

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

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Uroplasty, Inc

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: October 9, 2008
• First Submitted That Met QC Criteria: October 10, 2008
• First Posted (Estimate): October 13, 2008

Study Record Updates

• Last Update Posted (Estimate): April 18, 2012
• Last Update Submitted That Met QC Criteria: April 13, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: Overactive Bladder
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive
• Other Study ID Numbers: UPC082008