Trial of Percutaneous Tibial Nerve Stimulation (PTNS) Versus PTNS and Fesoterodine Fumarate
Stopped early · Phase 4 · Has a placebo group
Conditions studied: Overactive Bladder
In brief
The investigators are studying two FDA-approved modalities used to treat overactive bladder to determine if they improve overactive bladder with or without urge incontinence when used together rather than separately, percutaneous tibial nerve stimulation (PTNS) versus PTNS and fesoterodine fumarate.
Key facts
- Study ID
- NCT01605617
- Run by
- Mayo Clinic
- People needed
- 4
- Starts
- 2012-06-01
- Expected to finish
- 2013-03-01
- Last updated by the study team
- 2014-02-05
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Female ages > 18 and < 100 years old without childbearing potential
- History of overactive bladder
- with or without urge incontinence)
- with or without a history of previous anticholinergic use
- At least 8 voids per 24 hours documented by history and physical and voiding diary
You may not qualify if…
- Has had PTNS modulation in the past
- Has a primary complaint of stress urinary incontinence
- History of an allergy or sensitivity to tolterodine tartrate tablets or its ingredients
- History of an allergy or sensitivity to fesoterodine tartrate tablets or its ingredients
- Has a recent positive urinalysis for infection
- Has taken anticholinergic medication in the last 4 weeks for overactive bladder
- Has any of the following:
- pacemakers or implantable defibrillators
- excessive bleeding
- urinary or gastric retention
- nerve damage and/or neuropathy
- myasthenia gravis, uncontrolled narrow angle glaucoma
- liver disease or kidney disease
- QT prolongation.
Where it is running
- Mayo Clinic in Arizona (MCSB and MCH) — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
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