Clinical trial NCT00771264: Study of Urgent PC Versus Sham Effectiveness in Treatment of Overactive Bladder Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Overactive Bladder
Keywords: Overactive Bladder
Lead sponsor: Uroplasty, Inc
Sponsor class: INDUSTRY
First posted: 2008-10-13
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: 13 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chico
country: United States
facility: Gregory L. Davis, M.D., FACOG, Inc.
state: California
city: Greenwich
country: United States
facility: Greenwich Urological Associates, P.C.
state: Connecticut
city: Naples
country: United States
facility: Specialists in Urology
state: Florida
city: Muskegon
country: United States
facility: Mercy Health Partners at the Lakes
state: Michigan
city: Royal Oak
country: United States
facility: Beaumont Hospital
state: Michigan
city: Grand Rapids
country: United States
facility: Grand Rapids Women's Health DBA Female Pelvic Medicine & Urogynecology Institue of Michigan
state: Minnesota
city: Minnetonka
country: United States
facility: Uroplasty, Inc
state: Minnesota
city: Royal Oak
country: United States
facility: Beaumont Hospital
state: Minnesota
city: Fremont
country: United States
facility: Urology Health Center, PC
state: Nebraska
city: Albany
country: United States
facility: Capital Region Urological Surgeons, PLLC
state: New York
city: White Plains
country: United States
facility: Central Missouri Women's Healthcare, LLC
state: New York
city: Greensboro
country: United States
facility: Alliance Urology Specialists
state: North Carolina
city: Oklahoma City
country: United States
facility: University of Oklahoma
state: Oklahoma
city: Richmond
country: United States
facility: Virginia Urology
state: Virginia
city: Issaquah
country: United States
facility: Athena Urology
state: Washington
Study officials:
References: