Mirabegron for the Treatment of Pain Motivated Urinary Frequency and Urgency in Women

NCT02981459 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2020-10-22

No results posted yet for this study

Summary

The specific purpose of this study is to provide objective data in prospective open label design (n=40) to support the use of Mirabegron as a treatment for pain related urinary frequency and urgency. Women with bladder pain have a poor response to traditional anticholinergic therapy for their symptoms of frequency and urgency.

Conditions

  • Urinary Frequency/Urgency
  • Bladder Irritable
  • Bladder Pain Syndrome

Interventions

DRUG

Mirabegron

daily mirabegron 25mg with the option to increase dose based on symptoms to 50mg daily after 4 weeks

Sponsors & Collaborators

  • Astellas Pharma Inc

    collaborator INDUSTRY
  • State University of New York at Buffalo

    lead OTHER

Principal Investigators

  • Tova S Ablove, MD · University at Buffalo

  • Vanessa Barnabei, MD PHD · University at Buffalo

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-08
Primary Completion
2018-06-30
Completion
2018-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT02981459 on ClinicalTrials.gov