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

History of Changes

Tracking Information
First Received Date ^ICMJE	October 9, 2008
Last Updated Date	April 13, 2012
Start Date ^ICMJE	September 2008
Primary Completion Date	June 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 26, 2010)	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.
Original Primary Outcome Measures ^ICMJE (submitted: October 10, 2008)	The Global Response Assessment (GRA) for overall bladder symptoms will be used to compare the proportion of subjects reporting "moderately" or "markedly improved" responses on the GRA after 12 interventions of randomized therapy.
Change History	Complete list of historical versions of study NCT00771264 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Study of Urgent PC Versus Sham Effectiveness in Treatment of Overactive Bladder Symptoms
Official Title ^ICMJE	Not Provided
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Overactive Bladder
Intervention ^ICMJE	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).
Study Arm (s)	Active Comparator: Urgent PC Intervention: Device: Urgent PC Neuromodulation System No Intervention: Sham / Placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	220
Completion Date	June 2009
Primary Completion Date	June 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00771264
Other Study ID Numbers ^ICMJE	UPC082008
Has Data Monitoring Committee	Not Provided
Responsible Party	Uroplasty, Inc
Study Sponsor ^ICMJE	Uroplasty, Inc
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Uroplasty, Inc
Verification Date	April 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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