Overactive Bladder Innovative Therapy Trial (OrBIT)

Uroplasty, Inc100 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Overactive Bladder

Interventions

Urgent PC Neuromodulation SystemDEVICE

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).

TolterodineDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Uroplasty, Inc

Minnetonka, Minnesota, United States

Outcomes

Primary Outcomes

Frequency of Voids at 12 Weeks

To demonstrate that the Urgent PC system is as effective as or more effective (noninferior) than tolterodine (Detrol LA) in changing the frequency of urinary voids per day after 12 weeks of therapy. The voiding diaries completed at 12 weeks were compared to the baseline voiding diaries.

Time frame: Baseline to 12 weeks

Secondary Outcomes

Urge Incontinence Episodes at 12 Weeks

Time frame: 12 weeks

Volume Voided at 12 Weeks

Time frame: 12 weeks

OAB Quality of Life at 12 Weeks

Time frame: 12 weeks

Known Side Effects Through 12 Weeks

Time frame: 12 weeks

Data from ClinicalTrials.gov

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