Overactive Bladder Innovative Therapy Trial (OrBIT)

NCT ID: NCT00448175

Last Updated: 2013-05-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2008-10-31

Brief Summary

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The purpose of this study is to compare percutaneous tibial nerve stimulation (PTNS) to drug therapy for the treatment of symptoms of overactive bladder (OAB).

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

NONE

Study Groups

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Urgent PC treatment arm

Group Type EXPERIMENTAL

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).

Tolterodine

Intervention Type DRUG

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

Tolterodine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Is at least 18 years of age
* Experiences OAB with a voiding frequency of at least 8 times per day
* Is ambulatory and able to use a toilet independently and without difficulty

Exclusion Criteria

* On OAB pharmacotherapy within the previous month
* Primary complaint is stress urinary incontinence
* Has pacemaker or implantable defibrillator
* Has history of heart problems
* Has nerve damage or neuropathy
* Has gastric or urinary retention
* Has uncontrolled narrow-angle glaucoma
* Has known sensitivity to drug ingredients
* Is pregnant or planning to become pregnant during the trial
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Uroplasty, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Megan O'Toole

Role: STUDY_DIRECTOR

Uroplasty, Inc

Locations

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Uroplasty, Inc

Minnetonka, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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UPC032006

Identifier Type: -

Identifier Source: org_study_id

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