Patients With Low Bladder Compliance of 20ml/H2O or Less Despite Taking AnticholinergicsNCT05745584
Effect of Mirabegron on Bladder Compliance
A study testing Mirabegron (beta3-adrenoceptor agonist), Anticholinergics in people with Patients With Low Bladder Compliance of 20ml/H2O or Less Despite Taking Anticholinergics, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 100 years
- Conditions the study is for
- Patients With Low Bladder Compliance of 20ml/H2O or Less Despite Taking Anticholinergics
- What is being tested?
- Mirabegron (beta3-adrenoceptor agonist), Anticholinergics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Jan 2016to 2 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei University Health System, Severance Hospital
Seoul
About this study
Official title: Effect of Mirabegron on Bladder Compliance ; a Prospective Paired Comparison of Mirabegron and Anticholinergics in Patients With Low Bladder Compliance
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.
Read the 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.
- Being tested
- Mirabegron (beta3-adrenoceptor agonist), Anticholinergics
- Keywords
- Mirabegron, Beta3-adrenoceptor agonist, Bladder compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirabegron (beta3-adrenoceptor agonist), AnticholinergicsDrug
Administration of Mirabegron (beta3-adrenoceptor agonist) for 8 weeks, and followed by subsequent administration of anticholinergics for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | 8 weeks of mirabegron treatment==> 8 weeks of anticholinergics treatment Receives: Drug: Mirabegron (beta3-adrenoceptor agonist), Anticholinergics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Bladder compliance is assessed after 8 weeks of Mirabegron, and after 8 weeks of anticholinergics
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start12 Jan 2016
- Primary completion2 Mar 2023 (estimated)
- Study completion2 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Low Bladder Compliance of 20ml/H2O or Less Despite Taking AnticholinergicsStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jang Hwan Kim, Principal investigator, Department of Urology and Urological Science Institute, Yonsei University College of Medicine, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05745584
- Sponsor's protocol ID
- 4-2015-0938
- Status last verified
- Feb 2023
- First submitted
- 3 Feb 2023
- Last updated
- 27 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mirabegron on Bladder Compliance ; a Prospective Paired Comparison of Mirabegron and Anticholinergics in Patients With Low Bladder Compliance
- ClinicalTrials.gov ID
- NCT05745584
- Acronym / sponsor ID
- 4-2015-0938
- Keywords
- Mirabegron, Beta3-adrenoceptor agonist, Bladder compliance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 12 Jan 2016 (actual)
- Primary completion
- 2 Mar 2023 (estimated)
- Study completion
- 2 Mar 2023 (estimated)
- First posted
- 27 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Mirabegron (beta3-adrenoceptor agonist), Anticholinergics8 weeks of mirabegron treatment==> 8 weeks of anticholinergics treatment |
Who may qualify
- Ages
- 19 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mirabegron (beta3-adrenoceptor agonist), AnticholinergicsAdministration of Mirabegron (beta3-adrenoceptor agonist) for 8 weeks, and followed by subsequent administration of anticholinergics for 8 weeks | Drug | Experimental |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2023.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jang Hwan Kim principal investigator
Department of Urology and Urological Science Institute, Yonsei University College of Medicine, Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mirabegron (beta3-adrenoceptor agonist), Anticholinergics in people with Patients With Low Bladder Compliance of 20ml/H2O or Less Despite Taking Anticholinergics, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2023.