Overactive Bladder Innovative Therapy Trial (OrBIT)

NCT00448175 | Completed Phase 4 Results

• 1 other identifier: UPC032006
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Overactive Bladder

Keywords

OAB symptoms of urgency, frequency, and urge incontinence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (1)

Urgent PC treatment arm

EXPERIMENTAL

Device: Urgent PC Neuromodulation System; Drug: Tolterodine

Interventions

Urgent PC Neuromodulation System 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).

Urgent PC treatment arm

Tolterodine DRUG

Urgent PC treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Uroplasty, Inc: lead

Study Sites (1)

Uroplasty, Inc

Minnetonka, Minnesota, 55343, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence, Urge

Interventions

Tolterodine Tartrate

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Incontinence; Urination Disorders

Intervention Hierarchy (Ancestors)

Phenylpropanolamine; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Cresols; Phenols

Results Point of Contact

• Title: Clinical Study Manager
• Organization: Uroplasty, Inc

megan.otoole@uroplasty.com

952-426-6153

Study Officials

• Megan O'Toole

  Uroplasty, Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2007
• First Posted: March 16, 2007
• Study Start: June 1, 2006
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: May 16, 2013
• Results First Posted: May 16, 2013

Record last verified: 2013-04

Locations

US (1)