Effect of Mirabegron on Bladder Compliance ; a Prospective Paired Comparison of Mirabegron and Anticholinergics in Patients With Low Bladder Compliance
Overview
- Phase
- Not Applicable
- Intervention
- Mirabegron (beta3-adrenoceptor agonist), Anticholinergics
- Conditions
- Patients With Low Bladder Compliance of 20ml/H2O or Less Despite Taking Anticholinergics
- Sponsor
- Yonsei University
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Comparison of changes in Bladder compliance at 8 weeks after administration of each drug
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
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
Arms & Interventions
Experimental
8 weeks of mirabegron treatment==\> 8 weeks of anticholinergics treatment
Intervention: Mirabegron (beta3-adrenoceptor agonist), Anticholinergics
Outcomes
Primary Outcomes
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.