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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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TCTR |
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Last refreshed on:
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21 June 2021 |
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Main ID: |
TCTR20210420005 |
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Date of registration:
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20/04/2021 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Randomized Placebo Controlled Trial of Mirabegron on Alleviating Stent-Related Symptoms among Patients with Indwelling Double J Stent
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Scientific title:
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A Randomized Placebo Controlled Trial of Mirabegron on Alleviating Stent-Related Symptoms among Patients with Indwelling Double J Stent |
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Date of first enrolment:
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18/03/2021 |
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Target sample size:
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52 |
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Recruitment status: |
Recruiting |
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URL:
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www.thaiclinicaltrials.org/show/TCTR20210420005 |
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Study type:
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Interventional |
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Study design:
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Randomized
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Phase:
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Phase 2
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Countries of recruitment
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Thailand
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Contacts
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Name:
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Mookdarat
Siantong |
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Address:
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10400
10400
Bangkok
Thailand |
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Telephone:
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022011315 |
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Email:
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mookdarat.s@gmail.com |
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Affiliation:
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Faculty of medicine Ramathibodi Hospital Mahidol University |
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Name:
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Mookdarat
Siantong |
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Address:
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10400
10400
Bangkok
Thailand |
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Telephone:
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022011315 |
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Email:
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mookdarat.s@gmail.com |
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Affiliation:
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Faculty of medicine Ramathibodi Hospital Mahidol University |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1.Duration of age is 19-80 years
2. The patients undergoing DJ stent insertion after ureteroscopy, retrograde intrarenal surgery
3. The patients undergoing DJ stent insertion from other causes of urinary obstruction including pelvic and intraabdominal malignancies.
4. The patients have to be literate.
5. The patients are willing to be in the study.
4.Research participants must be able to read and write.
Exclusion criteria: 1. Patients using the alpha blockers, anticholinergics more than 2 weeks.
2. Patients using the Mirabegron continuously for more than 1 week.
3. Patients with previous exploratory laparotomy or other open abdominal surgery.
4. Patients with stents on both sides.
5. Pregnant and lactating patients.
6. Patients with Severe cardiovascular or cerebrovascular disease.
7. Patient has uncontrolled hypertension.
8. Patients allergic to Mirabegron
9. The patient refused and asked to withdraw.
Age minimum:
19 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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headache, urinary retention, and hypertension in certain patients.
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Mirabegron might cause headache, urinary retention, and hypertension in certain patients. This clinical trial has excluded patients with severe cardiovascular diseases from the study. If the patients have side effects from the drug used in this study, the researcher will stop giving medication to the patient, and treat the complications accordingly.
headache, urinary retention, and hypertension in certain patients.
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Intervention(s)
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Control group,Treatment group
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Placebo 1 tab po OD pc,Mirabegron(50) 1 tab po OD pc
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Placebo Comparator Drug,Active Comparator Drug
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Primary Outcome(s)
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Urinary stent symptoms scores 1 month Urinary symptoms score questionnaire
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Secondary Outcome(s)
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side effects 1 month numbers of adverse events
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Secondary ID(s)
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Nil Known
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Source(s) of Monetary Support
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Faculty of medicine Ramathibodi Hospital Mahidol University
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Ethics review
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Status: Submitted, approved
Approval date: 24/02/2021
Contact:
raec.mahidol@gmail.com
raec.mahidol@gmail.com
022012175 Ext.
raec.mahidol@gmail.com
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Results
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Results available:
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Date Posted:
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Date Completed:
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31/08/2022 |
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URL:
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