NCT06124066

THE EFFECTS OF MIRABEGRON AND TAMSULOSIN FOR PATIENTS WITH URETERAL STENTS

Completed Phase 4 Last updated 13 November 2023

What this trial tests

Phase 4 trial testing Mirabegron 50 MG in Ureteral Stone in 42 participants. Completed in 30 October 2022.

Timeline

1 July 2022

Primary endpoint
30 September 2022

30 October 2022

Quick facts

Lead sponsor	Hasanuddin University
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	42
Start date	1 July 2022
Primary completion	30 September 2022
Estimated completion	30 October 2022
Sites	1 location across Indonesia

Drugs / interventions tested

• Mirabegron 50 MG — full drug profile →

Conditions studied

• Ureteral Stone — all drugs for Ureteral Stone →
• Kidney Stones — all drugs for Kidney Stones →
• Ureteral Stenosis — all drugs for Ureteral Stenosis →

Sponsor

Hasanuddin University

Who can join

18 and older, any sex, with Ureteral Stone or Kidney Stones. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Double J stent (ureteral stent) can cause discomfort to patients, generally due to irritation of the bladder mucosa, especially in the trigone area, smooth muscle spasm, and reflux of urine into the ureter. Complaints often appear in patients, especially lower urinary tract symptoms (LUTS), pain in the waist when urinating due to reflux of urine, sexual dysfunction, and hematuria.

Currently, to assess complaints after ureteral stent placement, the Ureteral Stent Symptom Questionnaire instrument consists of 6 topics: urinary complaints, pain, general health, work, sexual problems, and other things.

Interleukin-6 is an important inflammatory cytokine when irritation occurs after ureteral stent placement. Interleukin 10 is a cytokine with potent anti-inflammatory properties that plays a central role in limiting the host's immune response to pathogens, thereby preventing host damage and maintaining normal tissue homeostasis. The profile of these biomarkers has the potential to determine the correct prognosis and therapy.

Mirabegron is a β3 adrenergic receptor agonist that has a dual antioxidant effect that plays a key role in the first step of the antimicrobial response and early resolution of inflammation so that post-stent complaints similar to overactive bladder complaints can be resolved. Tamsulosin (a selective α1A- and α1D-adrenoceptor antagonist) has a relaxing effect on the smooth muscle in the prostate, the neck of the bladder, and the distal ureter, thereby reducing the inflammatory reaction and improving oxidative stress by reducing the formation of reactive oxidative stress.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.