Trial of Percutaneous Tibial Nerve Stimulation (PTNS) Versus PTNS and Fesoterodine Fumarate
| Status: | Completed |
|---|---|
| Conditions: | Overactive Bladder |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/4/2013 |
| Start Date: | June 2012 |
| End Date: | December 2013 |
| Contact: | Debra Ryan |
| Email: | Ryan.Debra29@mayo.edu |
| Phone: | 480-342-1208 |
Prospective Randomized Trial of Percutaneous Tibial Nerve Stimulation (PTNS) Versus PTNS and Fesoterodine Fumarate
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
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