Status:
COMPLETED
Study of Urgent PC Versus Sham Effectiveness in Treatment of Overactive Bladder Symptoms
Lead Sponsor:
Uroplasty, Inc
Conditions:
Overactive Bladder
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 (O...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT00771264
Start Date
September 1 2008
End Date
June 1 2009
Last Update
April 18 2012
Active Locations (15)
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1
Gregory L. Davis, M.D., FACOG, Inc.
Chico, California, United States, 95928
2
Greenwich Urological Associates, P.C.
Greenwich, Connecticut, United States, 06830
3
Specialists in Urology
Naples, Florida, United States, 34102
4
Mercy Health Partners at the Lakes
Muskegon, Michigan, United States, 49444