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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2009-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Overactive Bladder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Urgent PC

Group Type ACTIVE_COMPARATOR

Urgent PC Neuromodulation System

Intervention Type DEVICE

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).

Sham / Placebo

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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).

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes