Clinical trial NCT01605617: Trial of Percutaneous Tibial Nerve Stimulation (PTNS) Versus PTNS and Fesoterodine Fumarate
Official title: Prospective Randomized Trial of Percutaneous Tibial Nerve Stimulation (PTNS) Versus PTNS and Fesoterodine Fumarate
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Overactive Bladder
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2012-05-25
Enrollment: 4
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
measure: Number of Urinary Voids Per 24 Hours After 12 Weeks of Therapy
timeFrame: From baseline to 12 weeks post treatment
Secondary outcomes:
measure: Mean Change in Urinary Urge Incontinence Episodes in 24 Hours
timeFrame: Baseline, 12 weeks post treatment
measure: Number of Voids Causing Waking
timeFrame: From baseline to 12 weeks post treatment
measure: Volume Voided Per Day
timeFrame: From baseline to 12 weeks post treatment
measure: Number of Urgency Episodes Scored by the Indevus Urgency Severity Scale (IUSS)
timeFrame: baseline, 12 weeks post treatment
measure: Change in Score on Overactive Bladder Questionnaire (QAB-q)
timeFrame: Baseline, 12 weeks post treatment
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic in Arizona (MCSB and MCH)
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Jeffrey Cornella, MD
role: PRINCIPAL_INVESTIGATOR
References: