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Effect of Mirabegron on Bladder Compliance

Primary Purpose

Patients With Low Bladder Compliance of 20ml/H2O or Less Despite Taking Anticholinergics

Status
Active
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Mirabegron (beta3-adrenoceptor agonist), Anticholinergics
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patients With Low Bladder Compliance of 20ml/H2O or Less Despite Taking Anticholinergics focused on measuring Mirabegron, Beta3-adrenoceptor agonist, Bladder compliance

Eligibility Criteria

19 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients over 19 years of age Bladder compliance is 20ml/cmH2O or less Patient who has been treated with antimuscarinic for at least 1 month, but has not been effective. Patient who agrees to and signs the informed consent Exclusion Criteria: 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. Those who have previously undergone bladder augmentation Those who currently have an indwelled catheter for urination Those with abnormal findings in renal function (serum creatinine >2 mg/dL) 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) Those with a history of bladder cancer before screening Those who were diagnosed with interstitial cystitis Those with active UTI Those who are pregnant or breastfeeding Those with a history of previous treatment with mirabegron Those who are allergic to beta 3 agonist, who are expected to be allergic to mirabegron Those confirmed as resting SBP >180 mmHg and/or DBP >110 mmHg Those confirmed as resting HR >100 beats per minute 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. Those who do not respond to surveys and research follow-up visits Those for whom the researcher judges that the treatment method of this study is not the best treatment for the patient

Sites / Locations

  • Yonsei University Health System, Severance Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental

Arm Description

8 weeks of mirabegron treatment==> 8 weeks of anticholinergics treatment

Outcomes

Primary Outcome Measures

Comparison of changes in Bladder compliance at 8 weeks after administration of each drug
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.

Secondary Outcome Measures

Full Information

First Posted
February 3, 2023
Last Updated
February 15, 2023
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT05745584
Brief Title
Effect of Mirabegron on Bladder Compliance
Official Title
Effect of Mirabegron on Bladder Compliance ; a Prospective Paired Comparison of Mirabegron and Anticholinergics in Patients With Low Bladder Compliance
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 12, 2016 (Actual)
Primary Completion Date
March 2, 2023 (Anticipated)
Study Completion Date
March 2, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Low Bladder Compliance of 20ml/H2O or Less Despite Taking Anticholinergics
Keywords
Mirabegron, Beta3-adrenoceptor agonist, Bladder compliance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
8 weeks of mirabegron treatment==> 8 weeks of anticholinergics treatment
Intervention Type
Drug
Intervention Name(s)
Mirabegron (beta3-adrenoceptor agonist), Anticholinergics
Intervention Description
Administration of Mirabegron (beta3-adrenoceptor agonist) for 8 weeks, and followed by subsequent administration of anticholinergics for 8 weeks
Primary Outcome Measure Information:
Title
Comparison of changes in Bladder compliance at 8 weeks after administration of each drug
Description
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.
Time Frame
Bladder compliance is assessed after 8 weeks of Mirabegron, and after 8 weeks of anticholinergics

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients over 19 years of age Bladder compliance is 20ml/cmH2O or less Patient who has been treated with antimuscarinic for at least 1 month, but has not been effective. Patient who agrees to and signs the informed consent Exclusion Criteria: 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. Those who have previously undergone bladder augmentation Those who currently have an indwelled catheter for urination Those with abnormal findings in renal function (serum creatinine >2 mg/dL) 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) Those with a history of bladder cancer before screening Those who were diagnosed with interstitial cystitis Those with active UTI Those who are pregnant or breastfeeding Those with a history of previous treatment with mirabegron Those who are allergic to beta 3 agonist, who are expected to be allergic to mirabegron Those confirmed as resting SBP >180 mmHg and/or DBP >110 mmHg Those confirmed as resting HR >100 beats per minute 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. Those who do not respond to surveys and research follow-up visits Those for whom the researcher judges that the treatment method of this study is not the best treatment for the patient
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jang Hwan Kim
Organizational Affiliation
Department of Urology and Urological Science Institute, Yonsei University College of Medicine, Severance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yonsei University Health System, Severance Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Effect of Mirabegron on Bladder Compliance

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