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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: March 27, 2013
Last verified: March 2013
History of Changes
  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
 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:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Frequency 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: From baseline to 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: From baseline to 12 weeks post treatment ] [ Designated as safety issue: No ]
  • Overactive Bladder Questionnaire (QAB-q) [ Time Frame: From baseline to 12 weeks post treatment ] [ Designated as safety issue: No ]

Enrollment: 3
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 at the first period
Participants will be given 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
Placebo Comparator: PTNS with placebo at the first period
Participants will be given PTNS + placebo for 12 weeks followed by 4 weeks of washout followed by 12 weeks of PTNS + 4mg of fesoterodine fumarate
 Drug: Placebo
PTNS + placebo for 12 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
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
Last Updated: March 27, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013