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

NCT01605617 | Terminated Phase 4 Results

• 1 other identifier: 11-004589
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Overactive Bladder

Outcome Measures

Primary Outcomes (1)

• Number of Urinary Voids Per 24 Hours After 12 Weeks of Therapy

  From baseline to 12 weeks post treatment

Secondary Outcomes (5)

• Mean Change in Urinary Urge Incontinence Episodes in 24 Hours

  Baseline, 12 weeks post treatment

• Number of Voids Causing Waking

  From baseline to 12 weeks post treatment

• Volume Voided Per Day

  From baseline to 12 weeks post treatment

• Number of Urgency Episodes Scored by the Indevus Urgency Severity Scale (IUSS)

  baseline, 12 weeks post treatment

• Change in Score on Overactive Bladder Questionnaire (QAB-q)

  Baseline, 12 weeks post treatment

Study Arms (2)

PTNS + fesoterodine fumarate first, then PTNS + placebo

ACTIVE COMPARATOR

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; Drug: Placebo; Procedure: Percutaneous Tibial Nerve Stimulation (PTNS)

PTNS + placebo first, then PTNS + fesoterodine fumarate

PLACEBO COMPARATOR

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; Drug: Placebo; Procedure: Percutaneous Tibial Nerve Stimulation (PTNS)

Interventions

Fesoterodine fumarate DRUG

PTNS + 4mg of fesoterodine fumarate for 12 weeks

Also known as: Toviaz

PTNS + fesoterodine fumarate first, then PTNS + placebo; PTNS + placebo first, then PTNS + fesoterodine fumarate

Placebo DRUG

PTNS + placebo for 12 weeks

PTNS + fesoterodine fumarate first, then PTNS + placebo; PTNS + placebo first, then PTNS + fesoterodine fumarate

Percutaneous Tibial Nerve Stimulation (PTNS) 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 + fesoterodine fumarate first, then PTNS + placebo; PTNS + placebo first, then PTNS + fesoterodine fumarate

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Arizona (MCSB and MCH)

Phoenix, Arizona, 85054, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

fesoterodine

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The study was terminated due to a low recruitment rate prior to subjects completing treatment.

Results Point of Contact

• Title: Dr. Jeffrey L. Cornella
• Organization: Mayo Clinic

cornella.jeffrey@mayo.edu

480-342-2867

Study Officials

• Jeffrey Cornella, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Obstetrics-Gynecology, College of Medicine

Study Record Dates

• First Submitted: May 3, 2012
• First Posted: May 25, 2012
• Study Start: June 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: February 5, 2014
• Results First Posted: February 5, 2014

Record last verified: 2013-12

Locations

US (1)