Phase 4
Completed N=100
Overactive Bladder Innovative Therapy Trial (OrBIT)
Source: ClinicalTrials.gov NCT00448175 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
May 2013
Primary outcomePrimary: Frequency of Voids at 12 Weeks — -2.4; -2.5 Voids/day
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Frequency of Voids at 12 Weeks |
-2.4; -2.5 | — |
| SECONDARY Urge Incontinence Episodes at 12 Weeks |
— | — |
| SECONDARY Volume Voided at 12 Weeks |
— | — |
| SECONDARY OAB Quality of Life at 12 Weeks |
— | — |
| SECONDARY Known Side Effects Through 12 Weeks |
— | — |
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
Data sourced from ClinicalTrials.gov (NCT00448175). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.