Overactive Bladder Innovative Therapy Trial (OrBIT)

Overactive Bladder Clinical Trial

— OrBIT  

Official title:

Overactive Bladder Innovative Therapy Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00448175
• Other study ID #: UPC032006
• Status: Completed
• Phase: Phase 4
• First received: March 15, 2007
• Last updated: April 4, 2013
• Start date: June 2006
• Est. completion date: October 2008

Study information

• Verified date: April 2013
• Source: Uroplasty, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

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).

Drug:
• Tolterodine

Locations

Country	Name	City	State
United States	Uroplasty, Inc	Minnetonka	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Uroplasty, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Urge Incontinence Episodes at 12 Weeks		12 weeks	No
Secondary	Volume Voided at 12 Weeks		12 weeks	No
Secondary	OAB Quality of Life at 12 Weeks		12 weeks	No
Secondary	Known Side Effects Through 12 Weeks		12 weeks	Yes