Trial of Percutaneous Tibial Nerve Stimulation (PTNS) Versus PTNS and Fesoterodine Fumarate

• Status: Terminated
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Treatments: Fesoterodine

Criteria

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.