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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | 8 weeks of mirabegron treatment==> 8 weeks of anticholinergics treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mirabegron (beta3-adrenoceptor agonist), Anticholinergics | Drug | Administration of Mirabegron (beta3-adrenoceptor agonist) for 8 weeks, and followed by subsequent administration of anticholinergics for 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Bladder compliance is assessed after 8 weeks of Mirabegron, and after 8 weeks of anticholinergics |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jang Hwan Kim | Department of Urology and Urological Science Institute, Yonsei University College of Medicine, Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei University Health System, Severance Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| C520025 | mirabegron |
| D018680 | Cholinergic Antagonists |
| ID | Term |
|---|---|
| D018678 | Cholinergic Agents |
| D018377 | Neurotransmitter Agents |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
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| D020164 | Chemical Actions and Uses |
| D045505 | Physiological Effects of Drugs |