Effect of Mirabegron on Bladder Compliance

Launched by YONSEI UNIVERSITY · Feb 15, 2023

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• 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