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Overactive Bladder Innovative Therapy Trial (OrBIT) (OrBIT)

Primary Purpose

Overactive Bladder

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Urgent PC Neuromodulation System
Tolterodine
Sponsored by
Uroplasty, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder focused on measuring OAB symptoms of urgency, frequency, and urge incontinence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Uroplasty, Inc

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Urgent PC treatment arm

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Urge Incontinence Episodes at 12 Weeks
Volume Voided at 12 Weeks
OAB Quality of Life at 12 Weeks
Known Side Effects Through 12 Weeks

Full Information

First Posted
March 15, 2007
Last Updated
April 4, 2013
Sponsor
Uroplasty, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00448175
Brief Title
Overactive Bladder Innovative Therapy Trial (OrBIT)
Acronym
OrBIT
Official Title
Overactive Bladder Innovative Therapy Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Uroplasty, Inc

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder
Keywords
OAB symptoms of urgency, frequency, and urge incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Urgent PC treatment arm
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Urgent PC Neuromodulation System
Intervention Description
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
Drug
Intervention Name(s)
Tolterodine
Primary Outcome Measure Information:
Title
Frequency of Voids at 12 Weeks
Description
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 Outcome Measure Information:
Title
Urge Incontinence Episodes at 12 Weeks
Time Frame
12 weeks
Title
Volume Voided at 12 Weeks
Time Frame
12 weeks
Title
OAB Quality of Life at 12 Weeks
Time Frame
12 weeks
Title
Known Side Effects Through 12 Weeks
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Megan O'Toole
Organizational Affiliation
Uroplasty, Inc
Official's Role
Study Director
Facility Information:
Facility Name
Uroplasty, Inc
City
Minnetonka
State/Province
Minnesota
ZIP/Postal Code
55343
Country
United States

12. IPD Sharing Statement

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Overactive Bladder Innovative Therapy Trial (OrBIT)

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