Trial of Percutaneous Tibial Nerve Stimulation (PTNS) Versus PTNS and Fesoterodine Fumarate
Information source: Mayo Clinic
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Overactive Bladder
Intervention: Fesoterodine fumarate (Drug); Placebo (Drug); Percutaneous Tibial Nerve Stimulation (PTNS) (Procedure)
Phase: Phase 4
Status: Terminated
Sponsored by: Mayo Clinic Official(s) and/or principal investigator(s): Jeffrey Cornella, MD, Principal Investigator, Affiliation: Mayo Clinic
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.
Clinical Details
Official title: Prospective Randomized Trial of Percutaneous Tibial Nerve Stimulation (PTNS) Versus PTNS and Fesoterodine Fumarate
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Number of Urinary Voids Per 24 Hours After 12 Weeks of Therapy
Secondary outcome: Mean Change in Urinary Urge Incontinence Episodes in 24 HoursNumber of Voids Causing Waking Volume Voided Per Day Number of Urgency Episodes Scored by the Indevus Urgency Severity Scale (IUSS) Change in Score on Overactive Bladder Questionnaire (QAB-q)
Detailed description:
Overactive bladder (OAB) is described as urinary urgency with or without urge incontinence,
usually associated with urinary frequency and nocturia. The primary complaint is a strong
desire to void without the ability to postpone micturition. Two treatments used in the
treatment of OAB are pharmacotherapy and percutaneous tibial nerve stimulation (PTNS).
Pharmacotherapy for OAB is based on medications that block the muscarinic receptors of the
detrusor muscle. These particular receptors are not unique to the bladder, however, and
patients complain of bothersome side effects that are a result of systemic muscarinic
receptor blockade. Medications are successful for many patients but compliance is poor and
many patients discontinue the medications as a result of side effects, cost, and
insufficient symptom improvement.
Percutaneous tibial nerve stimulation (PTNS) is a newer treatment modality that provides
neuromodulation to the pelvic floor by stimulating the posterior tibial nerve. This nerve
is accessed with a fine needle electrode that is inserted in the medial portion of the
ankle. This area has long been recognized as having nerve projections to the sacral nerve
plexus and can modulate bladder activity. Several studies have clearly demonstrated the
effectiveness of neuromodulation to treat urge incontinence.
There have been studies comparing the efficacy of pharmacotherapy versus PTNS. In one
study, 49% of subjects taking fesoterodine fumarate for urge incontinence reported an
improvement in symptoms of overactive bladder. In other studies, 79. 5% of patients
undergoing PTNS reported improvement or cure. Although studies report similar improvement
or cure between the two treatment modalities, there is no evidence of the efficacy of using
both PTNS and pharmacotherapy concurrently. This study is aimed at proving synergy between
the two treatment modalities when used together in an effort to administer smaller doses of
anticholinergic agents, while obtaining comparable or improved urge incontinence.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
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.
Locations and Contacts
Mayo Clinic in Arizona (MCSB and MCH), Phoenix, Arizona 85054, United States
Additional Information
Starting date: June 2012
Last updated: December 16, 2013
|