Effect of Mirabegron on Bladder Compliance

February 15, 2023 updated by: Yonsei University

Effect of Mirabegron on Bladder Compliance ; a Prospective Paired Comparison of Mirabegron and Anticholinergics in Patients With Low Bladder Compliance

In many cases of neurogenic bladder patients, bladder compliance is lowered, which is a factor that deteriorates renal function. It is known that deterioration of renal function is accompanied in 50 to 70% of patients with low bladder compliance. For patients with poor bladder compliance, a consensus has not yet been established regarding the treatment method. This is especially true in the case of drug treatment rather than surgical methods. There are limited cases where bladder compliance is improved with anticholinergics, which have been conventionally administered to the patients. According to the existing literature, increase of bladder compliance was observed in some patients with anticholinergics such as tolterodine, propiverine, and oxybutynin. But the bladder compliances were not completely normalized in every patient. Moreover, adverse effects of anticholinergics have been reported in a significant number of the patients.

The objective of this study is to analyze the effect of mirabegron (a beta3-adrenoceptor agonist) on bladder compliance in patients who had no effect on bladder compliance with prior anticholinergics treatment. In this study, low bladder compliance is defined as 20 ml/cmH2O or less.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This study will be conducted as a prospective paired comparison study. In this study, low bladder compliance is defined as 20 ml/cmH2O or less. For patients who had no effect on anticholinergic treatment (at least 1 month of treatment). Mirabegron 50mg/day is administered for 8 weeks; and then, previously administered antimuscarinics were administered again for another 8 weeks. On each visit day (after 8 weeks of mirabegron, and after 8 weeks of anticholinergics), urodynamics test, voiding diary, and patient symptom questionnaire evaluations are going to be performed.

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Yonsei University Health System, Severance Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients over 19 years of age
  2. Bladder compliance is 20ml/cmH2O or less
  3. Patient who has been treated with antimuscarinic for at least 1 month, but has not been effective.
  4. Patient who agrees to and signs the informed consent

Exclusion Criteria:

  1. Those who have taken clinical drugs with other ingredients (other than this experiment) for the past 60 days or participated in clinical trials using other types of medical devices.
  2. Those who have previously undergone bladder augmentation
  3. Those who currently have an indwelled catheter for urination
  4. Those with abnormal findings in renal function (serum creatinine >2 mg/dL)
  5. Those with abnormal liver function (serum AST/ALT >2 times upper limit, GGT >3 times upper limit of normal,total bilirubin >2 times upper limit of normal)
  6. Those with a history of bladder cancer before screening
  7. Those who were diagnosed with interstitial cystitis
  8. Those with active UTI
  9. Those who are pregnant or breastfeeding
  10. Those with a history of previous treatment with mirabegron
  11. Those who are allergic to beta 3 agonist, who are expected to be allergic to mirabegron
  12. Those confirmed as resting SBP >180 mmHg and/or DBP >110 mmHg
  13. Those confirmed as resting HR >100 beats per minute
  14. Male patients who are likely to become pregnant or donate sperm during the study period or within 28 days of the last drug administration of the study.
  15. Those who do not respond to surveys and research follow-up visits
  16. Those for whom the researcher judges that the treatment method of this study is not the best treatment for the patient

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
8 weeks of mirabegron treatment==> 8 weeks of anticholinergics treatment
Drug: Mirabegron (beta3-adrenoceptor agonist), Anticholinergics
Administration of Mirabegron (beta3-adrenoceptor agonist) for 8 weeks, and followed by subsequent administration of anticholinergics for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of changes in Bladder compliance at 8 weeks after administration of each drug
Time Frame: Bladder compliance is assessed after 8 weeks of Mirabegron, and after 8 weeks of anticholinergics
Bladder compliance is analyzed through urodynamic study (cystometrogram). During the cystometrogram test, the value obtained by dividing the maximum bladder volume by the detrusor pressure at end-filling is going to be analyzed.
Bladder compliance is assessed after 8 weeks of Mirabegron, and after 8 weeks of anticholinergics

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Investigators

  • Principal Investigator: Jang Hwan Kim, Department of Urology and Urological Science Institute, Yonsei University College of Medicine, Severance Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2016

Primary Completion (Anticipated)

March 2, 2023

Study Completion (Anticipated)

March 2, 2023

Study Registration Dates

First Submitted

February 3, 2023

First Submitted That Met QC Criteria

February 15, 2023

First Posted (Estimate)

February 27, 2023

Study Record Updates

Last Update Posted (Estimate)

February 27, 2023

Last Update Submitted That Met QC Criteria

February 15, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2015-0938

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Mirabegron (beta3-adrenoceptor agonist), Anticholinergics

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Papua New Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe