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

University at Buffalo (UB) logo

University at Buffalo (UB)

Status and phase

Withdrawn
Phase 4

Conditions

Bladder Irritable
Bladder Pain Syndrome
Urinary Frequency/Urgency

Treatments

Drug: Mirabegron

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02981459
030-586061

Details and patient eligibility

About

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.

Full description

Hypothesis: Mirabegron is effective in reducing symptoms in women with pain related urinary frequency and urgency.

Specific Aims:

  1. To measure the efficacy of Mirabegron in the treatment of frequency and urgency, using voiding diaries.
  2. To measure the number of patients with a 50% or greater reduction in frequency and urgency, using voiding diaries.
  3. To measure the number of patients with a 50% or greater reduction in bladder pain as measured in the O'Leary-Sant (OLS) IC symptom and problem, and the Lowell Parsons Pelvic Pain and Urgency/Frequency (PUF) patient symptom scale.

Intervention/Project goal: Treatment with Mirabegron 25mg for 4 weeks with an option for dose escalation to 50mg. Duration of study 12 weeks.

Inclusion criteria: Women between the ages of 18 and 89 with complaints of pain related urinary frequency are eligible to participate in the study.

Exclusion criteria:

Patients will be excluded from the study if they have:

  1. Severe Liver disease, Child-Pugh class c
  2. Severe Kidney disease, GFR<30
  3. Elevated blood pressure > 160/95 (in package insert bp >180/110)
  4. Urinary retention
  5. Pregnant, will become pregnant, or are nursing
  6. History of recurrent urinary tract infection
  7. Tachycardia: pulse > 100
  8. Presently on study drug mirabegron; patient must be willing to participate in a 30 day washout period to be eligible for inclusion
  9. Medications - metoprolol, desipramine, digoxin, propafenone, thioridazine, flecainide, warfarin

Sex

Female

Ages

18 to 89 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  1. Severe Liver disease: Child-Pugh class c
  2. Severe Kidney disease: GFR<30
  3. Elevated blood pressure > 160/95 (in package insert bp >180/110)
  4. Pregnant, will become pregnant, or are nursing during the study
  5. History of recurrent urinary tract infection: 3 or more culture proven urinary tract infections in the past 12 months. An active urinary tract infection.
  6. Tachycardia: pulse > 100, or any other history of arrhythmia
  7. Intense urge: bladder volumes of <150 ml on cystometry
  8. Presently on study drug mirabegron; patient must be willing to participate in a 30 day washout period to be eligible for inclusion
  9. Medications: metoprolol, desipramine, digoxin, propafenone, thioridazine, flecainide, warfarin
  10. Pain medications: no dose changes in narcotic or non-steroidal medications while on study. Patient must be on a stable medication dose for at least 30 days prior to the screening visit.
  11. Neurogenic pain medications such as gabapentin or amitriptyline: no dose changes while on study. Patient must be on a stable medication dose for at least 30 days prior to the screening visit.
  12. Anticholinergic medications for incontinence: no dose changes while on study. Patient must be on a stable medication dose for at least 30 days prior to the screening visit.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 1 patient group

Mirabegron 25 mg or 50 mg
Experimental group
Treatment:
Drug: Mirabegron

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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