Effect of Mirabegron on Bladder Compliance

NCT05745584 | Unknown DMC

• 1 other identifier: 4-2015-0938
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Patients With Low Bladder Compliance of 20ml/H2O or Less Despite Taking Anticholinergics

Keywords

Mirabegron; Beta3-adrenoceptor agonist; Bladder compliance

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Experimental

EXPERIMENTAL

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

Drug: Mirabegron (beta3-adrenoceptor agonist), Anticholinergics

Interventions

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

Experimental

Eligibility Criteria

• Age: 19 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

mirabegron; Cholinergic Antagonists

Intervention Hierarchy (Ancestors)

Cholinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs

Study Officials

• Jang Hwan Kim

  Department of Urology and Urological Science Institute, Yonsei University College of Medicine, Severance Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2023
• First Posted: February 27, 2023
• Study Start: January 12, 2016
• Primary Completion: March 2, 2023
• Study Completion: March 2, 2023
• Last Updated: February 27, 2023

Record last verified: 2023-02

Locations

KR (1)