Overactive Bladder Innovative Therapy Trial (OrBIT) (OrBIT)

Overactive Bladder Innovative Therapy Trial

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 Overview

• Status: Completed
• Conditions: Overactive Bladder
• Intervention / Treatment: Drug: Tolterodine; Device: Urgent PC Neuromodulation System

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minnetonka, Minnesota, United States, 55343
      • Uroplasty, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Urgent PC treatment arm	Drug: Tolterodine; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to 12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Urge Incontinence Episodes at 12 Weeks	12 weeks
Volume Voided at 12 Weeks	12 weeks
OAB Quality of Life at 12 Weeks	12 weeks
Known Side Effects Through 12 Weeks	12 weeks

Collaborators and Investigators

• Sponsor: Uroplasty, Inc
• Investigators: Study Director: Megan O'Toole, Uroplasty, Inc

Study record dates

Study Major Dates

• Study Start: June 1, 2006
• Primary Completion (ACTUAL): October 1, 2008
• Study Completion (ACTUAL): October 1, 2008

Study Registration Dates

• First Submitted: March 15, 2007
• First Submitted That Met QC Criteria: March 15, 2007
• First Posted (ESTIMATE): March 16, 2007

Study Record Updates

• Last Update Posted (ESTIMATE): May 16, 2013
• Last Update Submitted That Met QC Criteria: April 4, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: OAB symptoms of urgency, frequency, and urge incontinence
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Urological Agents; Tolterodine Tartrate
• Other Study ID Numbers: UPC032006