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

NCT ID: NCT01605617

Last Updated: 2014-02-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2013-03-31

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.

Conditions

Overactive Bladder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

PTNS + fesoterodine fumarate first, then PTNS + placebo

Participants were to be given Percutaneous Tibial Nerve Stimulation (PTNS) + 4mg of fesoterodine fumarate first for 12 weeks, and followed by 4 weeks of washout followed by 12 weeks of PTNS + placebo.

Group Type: ACTIVE_COMPARATOR

Fesoterodine fumarate

Intervention Type: DRUG

PTNS + 4mg of fesoterodine fumarate for 12 weeks

Placebo

Intervention Type: DRUG

PTNS + placebo for 12 weeks

Percutaneous Tibial Nerve Stimulation (PTNS)

Intervention Type: PROCEDURE

PTNS is an FDA-approved procedure for the diagnosis of overactive bladder, given on a weekly basis. Participants will be given PTNS + either 4mg of fesoterodine fumarate or placebo for 12 weeks, and followed by 4 weeks of washout followed by 12 weeks of PTNS + the opposite treatment (placebo or fesoterodine fumarate).

PTNS + placebo first, then PTNS + fesoterodine fumarate

Participants were to be given Percutaneous Tibial Nerve Stimulation (PTNS) + placebo for 12 weeks followed by 4 weeks of washout followed by 12 weeks of PTNS + 4mg of fesoterodine fumarate

Group Type: PLACEBO_COMPARATOR

Fesoterodine fumarate

Intervention Type: DRUG

PTNS + 4mg of fesoterodine fumarate for 12 weeks

Placebo

Intervention Type: DRUG

PTNS + placebo for 12 weeks

Percutaneous Tibial Nerve Stimulation (PTNS)

Intervention Type: PROCEDURE

PTNS is an FDA-approved procedure for the diagnosis of overactive bladder, given on a weekly basis. Participants will be given PTNS + either 4mg of fesoterodine fumarate or placebo for 12 weeks, and followed by 4 weeks of washout followed by 12 weeks of PTNS + the opposite treatment (placebo or fesoterodine fumarate).

Interventions

Fesoterodine fumarate

PTNS + 4mg of fesoterodine fumarate for 12 weeks

Intervention Type: DRUG

Placebo

PTNS + placebo for 12 weeks

Intervention Type: DRUG

Percutaneous Tibial Nerve Stimulation (PTNS)

PTNS is an FDA-approved procedure for the diagnosis of overactive bladder, given on a weekly basis. Participants will be given PTNS + either 4mg of fesoterodine fumarate or placebo for 12 weeks, and followed by 4 weeks of washout followed by 12 weeks of PTNS + the opposite treatment (placebo or fesoterodine fumarate).

Intervention Type: PROCEDURE

Other Intervention Names

Toviaz

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Jeffrey L. Cornella

Professor of Obstetrics-Gynecology, College of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeffrey Cornella, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Arizona (MCSB and MCH)

Phoenix, Arizona, United States

Countries

United States

Other Identifiers

11-004589

Identifier Type: -

Identifier Source: org_study_id