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

NCT01605617 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2014-02-05

Study results available
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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

Interventions

DRUG

Fesoterodine fumarate

PTNS + 4mg of fesoterodine fumarate for 12 weeks

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).

Sponsors & Collaborators

Principal Investigators

  • Jeffrey Cornella, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01605617 on ClinicalTrials.gov