WithdrawnPhase 4

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

Stopped: Withdrawn by Sponsor

United States0Started 2017-12-08

Plain-language 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.

Who can participate

Age range18 Years – 89 Years

SexFEMALE

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Inclusion criteria

✓. English-speaking women
✓. Age: 18 and 89 years
✓. Pain related urinary frequency or urgency associated with \>70% of voids. With a minimum of 7 pain motivated voids in 24 hours.
✓. Bladder capacity: \> 300 ml
✓. Urinary frequency: 10 or more voids in 24/hours on voiding diary

Exclusion criteria

✕. Severe Liver disease: Child-Pugh class c
✕. Severe Kidney disease: GFR\<30
✕. Elevated blood pressure \> 160/95 (in package insert bp \>180/110)
✕. Pregnant, will become pregnant, or are nursing during the study
✕. History of recurrent urinary tract infection: 3 or more culture proven urinary tract infections in the past 12 months. An active urinary tract infection.
✕. Tachycardia: pulse \> 100, or any other history of arrhythmia
✕. Intense urge: bladder volumes of \<150 ml on cystometry
✕. Presently on study drug mirabegron; patient must be willing to participate in a 30 day washout period to be eligible for inclusion

What they're measuring

The number of pain motivated voids per 24 hours.

Timeframe: 12 weeks

Trial details

NCT IDNCT02981459

SponsorState University of New York at Buffalo

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-06

View on ClinicalTrials.gov More Urinary Frequency/Urgency trials