Effect of Mirabegron on Bladder Compliance

Sponsor

Yonsei University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05745584

Collaborator

(none)

Enrollment

Location

Arm

85.6

Anticipated Duration (Months)

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Patients With Low Bladder Compliance of 20ml/H2O or Less Despite Taking Anticholinergics	Drug: Mirabegron (beta3-adrenoceptor agonist), Anticholinergics	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Effect of Mirabegron on Bladder Compliance ; a Prospective Paired Comparison of Mirabegron and Anticholinergics in Patients With Low Bladder Compliance

Actual Study Start Date :

Jan 12, 2016

Anticipated Primary Completion Date :

Mar 2, 2023

Anticipated Study Completion Date :

Mar 2, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental 8 weeks of mirabegron treatment==> 8 weeks of anticholinergics treatment	Drug: Mirabegron (beta3-adrenoceptor agonist), Anticholinergics Administration of Mirabegron (beta3-adrenoceptor agonist) for 8 weeks, and followed by subsequent administration of anticholinergics for 8 weeks

Arm

Intervention/Treatment

Experimental: Experimental

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

Drug: Mirabegron (beta3-adrenoceptor agonist), Anticholinergics

Administration of Mirabegron (beta3-adrenoceptor agonist) for 8 weeks, and followed by subsequent administration of anticholinergics for 8 weeks

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 100 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yonsei University Health System, Severance Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

Yonsei University

Investigators

Principal Investigator: Jang Hwan Kim, Department of Urology and Urological Science Institute, Yonsei University College of Medicine, Severance Hospital