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

Uroplasty

Status and phase

Completed

Phase 4

Conditions

Overactive Bladder

Treatments

Device: Urgent PC Neuromodulation System

Study type

Interventional

Funder types

Industry

Identifiers

NCT00771264

UPC082008

Details and patient eligibility

About

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.

Enrollment

220 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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