THE EFFECTS OF MIRABEGRON AND TAMSULOSIN FOR PATIENTS WITH URETERAL STENTS

• Status: Completed
• Trial end date: 2022-10-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hasanuddin University
• Treatments: Mirabegron; Tamsulosin

Criteria

Inclusion Criteria:

• Age > 18 years

• Patient with first ureterorenoscopy and ureteral stent placement

• Using a semi-rigid (rigid) retrograde or flexible (flexible) ureteroscope

• Stent placement on one side

• Stent installation size 4.7 Fr, length 24-26cm hydrophilic coated ureteric stent

• Patients who can read and understand Indonesia language (Bahasa Indonesia)

Exclusion Criteria:

• Patients with or who have a history of malignancy of the urinary tract

• Patients with LUTS caused by benign prostatic enlargement, bladder stones, or urethral strictures

• Catheterized patients or on self-catheter therapy regularly and patients with urinary diversion

• Patients with Post void residual volume > 350 mL

• Patients with neurogenic bladder and/or OAB syndrome, stress incontinence, or mixed stress/urge incontinence

• Patients with chronic pain that is not controlled or on therapy to manage chronic pain

• Patients with symptomatic UTI

• Patients with a prior history of sexual dysfunction

• Have or are currently undergoing radiation therapy/hormonal therapy and/or surgical procedures in the minor pelvis, ureteral reconstructive surgery.

• Patients with primary neurological disorders, such as multiple sclerosis, Parkinson's disease, diabetic nephropathy, or other neurological diseases that affect bladder function.

• Patients who are hypersensitive to mirabegron and tamsulosin or their derivatives and patients with mirabegron and tamsulosin contraindications.

• The patient could not follow the research protocol due to an organic brain disorder or psychiatric disorder

• Patients with autoimmune diseases and other inflammatory diseases, as well as patients taking immunosuppressant drugs