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

This study has been terminated.
(Low recruitment rate, and study patients were removed prior to completion)
Sponsor:
Information provided by (Responsible Party):
Jeffrey L. Cornella, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01605617
First received: May 3, 2012
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Overactive Bladder
Drug: Fesoterodine fumarate
Drug: Placebo
Procedure: Percutaneous Tibial Nerve Stimulation (PTNS)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Prospective Randomized Trial of Percutaneous Tibial Nerve Stimulation (PTNS) Versus PTNS and Fesoterodine Fumarate

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Number of Urinary Voids Per 24 Hours After 12 Weeks of Therapy [ Time Frame: From baseline to 12 weeks post treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean Change in Urinary Urge Incontinence Episodes in 24 Hours [ Time Frame: Baseline, 12 weeks post treatment ] [ Designated as safety issue: No ]
  • Number of Voids Causing Waking [ Time Frame: From baseline to 12 weeks post treatment ] [ Designated as safety issue: No ]
  • Volume Voided Per Day [ Time Frame: From baseline to 12 weeks post treatment ] [ Designated as safety issue: No ]
  • Number of Urgency Episodes Scored by the Indevus Urgency Severity Scale (IUSS) [ Time Frame: baseline, 12 weeks post treatment ] [ Designated as safety issue: No ]
    The IUSS has 4 levels: none, mild, moderate, and severe. An episode characterized as severe according to this scale would qualify as an urgency episode.

  • Change in Score on Overactive Bladder Questionnaire (QAB-q) [ Time Frame: Baseline, 12 weeks post treatment ] [ Designated as safety issue: No ]
    The QAB-q is a self-administered, 33-item questionnaire containing a symptom bother and health related quality of life scale. Each item has a choice of 6 responses, ranging from "not at all" to "a very great deal." Therefore, the total score could range from 33 (no discomfort) to 198 (great discomfort).


Enrollment: 4
Study Start Date: June 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Drug: Fesoterodine fumarate
PTNS + 4mg of fesoterodine fumarate for 12 weeks
Other Name: Toviaz
Drug: Placebo
PTNS + placebo for 12 weeks
Procedure: 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).
Placebo Comparator: 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
Drug: Fesoterodine fumarate
PTNS + 4mg of fesoterodine fumarate for 12 weeks
Other Name: Toviaz
Drug: Placebo
PTNS + placebo for 12 weeks
Procedure: 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).

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01605617

Locations
United States, Arizona
Mayo Clinic in Arizona (MCSB and MCH)
Phoenix, Arizona, United States, 85054
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Jeffrey Cornella, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Jeffrey L. Cornella, Professor of Obstetrics-Gynecology, College of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01605617     History of Changes
Other Study ID Numbers: 11-004589
Study First Received: May 3, 2012
Results First Received: September 24, 2013
Last Updated: December 16, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Fesoterodine
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 26, 2014