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NCT05745584
Effect of Mirabegron on Bladder Compliance
Conditions: Patients With Low Bladder Compliance of 20ml/H2O or Less Despite Taking Anticholinergics
Sex: All
Ages: 19 Years – 100 Years
Phase: NA
Enrollment: 15
Sponsor: Yonsei University
Location: Korea, Republic of
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.
Eligibility Criteria
Inclusion Criteria:Patients over 19 years of ageBladder compliance is 20ml/cmH2O or lessPatient who has been treated with antimuscarinic for at least 1 month, but has not been effective.Patient who agrees to and signs the informed consentExclusion 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 augmentationThose who currently have an indwelled catheter for urinationThose 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 screeningThose who were diagnosed with interstitial cystitisThose with active UTIThose who are pregnant or breastfeedingThose with a history of previous treatment with mirabegronThose who are allergic to beta 3 agonist, who are expected to be allergic to mirabegronThose confirmed as resting SBP >180 mmHg and/or DBP >110 mmHgThose confirmed as resting HR >100 beats per minuteMale 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 visitsThose for whom the researcher judges that the treatment method of this study is not the best treatment for the patient
Source: ClinicalTrials.gov (NCT05745584). StuddyBuddy aggregates publicly available trial information.