Study of Urgent PC Versus Sham Effectiveness in Treatment of Overactive Bladder Symptoms
SUmiT
1 other identifier
interventional
220
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2008
Shorter than P25 for phase_4
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 9, 2008
CompletedFirst Posted
Study publicly available on registry
October 13, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedResults Posted
Study results publicly available
September 21, 2010
CompletedApril 18, 2012
April 1, 2012
9 months
October 9, 2008
August 26, 2010
April 13, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
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
Study Arms (2)
Urgent PC
ACTIVE COMPARATORSham / Placebo
NO INTERVENTIONInterventions
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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Uroplasty, Inclead
Study Sites (15)
Gregory L. Davis, M.D., FACOG, Inc.
Chico, California, 95928, United States
Greenwich Urological Associates, P.C.
Greenwich, Connecticut, 06830, United States
Specialists in Urology
Naples, Florida, 34102, United States
Mercy Health Partners at the Lakes
Muskegon, Michigan, 49444, United States
Beaumont Hospital
Royal Oak, Michigan, 48703, United States
Grand Rapids Women's Health DBA Female Pelvic Medicine & Urogynecology Institue of Michigan
Grand Rapids, Minnesota, 49503, United States
Uroplasty, Inc
Minnetonka, Minnesota, 55343, United States
Beaumont Hospital
Royal Oak, Minnesota, 48073, United States
Urology Health Center, PC
Fremont, Nebraska, 68025, United States
Capital Region Urological Surgeons, PLLC
Albany, New York, 12208, United States
Central Missouri Women's Healthcare, LLC
White Plains, New York, 10604, United States
Alliance Urology Specialists
Greensboro, North Carolina, 27403, United States
University of Oklahoma
Oklahoma City, Oklahoma, 73104, United States
Virginia Urology
Richmond, Virginia, 23235, United States
Athena Urology
Issaquah, Washington, 98027, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Susan Holman, Cheif Operating Officer
- Organization
- Uroplasty, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 9, 2008
First Posted
October 13, 2008
Study Start
September 1, 2008
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
April 18, 2012
Results First Posted
September 21, 2010
Record last verified: 2012-04