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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Uroplasty, Inc
ClinicalTrials.gov Identifier:
NCT00771264
First received: October 9, 2008
Last updated: April 13, 2012
Last verified: April 2012
  Purpose

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 Intervention Phase
Overactive Bladder
Device: Urgent PC Neuromodulation System
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Uroplasty, Inc:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 220
Study Start Date: September 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00771264

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

No publications provided

Responsible Party: Uroplasty, Inc
ClinicalTrials.gov Identifier: NCT00771264     History of Changes
Other Study ID Numbers: UPC082008
Study First Received: October 9, 2008
Results First Received: August 26, 2010
Last Updated: April 13, 2012
Health Authority: United States: Institutional Review Board

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
Signs and Symptoms

ClinicalTrials.gov processed this record on September 16, 2014