THE EFFECTS OF MIRABEGRON AND TAMSULOSIN FOR PATIENTS WITH URETERAL STENTS

NCT06124066 | Completed Phase 4 DMC

• 1 other identifier: 583/UN4.6.4.5.37/PP36/2022
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ureteral Stone; Kidney Stones; Ureteral Stenosis

Keywords

Double J stent; Mirabegron; Tamsulosin; Interleukin-6; Interleukin-10; lower urinary tract symptoms

Outcome Measures

Primary Outcomes (4)

• serum and urine Interleukin-6 serum level (ELISA)

  Interleukin-6 serum level

  Pre-intervention and immediately after the intervention

• serum and urine Interleukin-10 serum level (ELISA)

  Interleukin-10 serum level

  Pre-intervention and immediately after the intervention

• Histopathology

  The severity of the mucosal inflammatory reaction was graded using a semiquantitative scale where 0=none, 1 = focal lymphocytic infiltration, 2 =diffuse predominantly lymphocytic infiltration, 3 =diffuse predominantly eosinophil polymorphonuclear infiltration and 4 = grade 3 changes in combination with intra-epithelial eosinophilic micro-abscesses.

  Pre-intervention and immediately after the intervention

• Urinary symptoms in the Ureteral Stent Symptom Questionnaire (USSQ) parameter

  Minimum values 2 and maximum values 47

  Pre-intervention, immediately after the interventio, and up to 4 weeks

Secondary Outcomes (1)

• Basis data

  pre-intervention

Study Arms (3)

Mirabegron

ACTIVE COMPARATOR

The participants were given mirabegron 50 mirabegron/day started 3 days before DJ stent insertion and until 6 weeks after the DJ stent insertion and filled in USSQ every week until 6 weeks after the DJ stent insertion(filled in directly when the patient arrived or by telephone)

Drug: Mirabegron 50 MG

Tamsulosin

ACTIVE COMPARATOR

The participants were given tamsulosin 0.4 mg that was started 3 days before DJ stent insertion and until 6 weeks after the DJ stent insertion and filled in USSQ every week until 6 weeks after the DJ stent insertion(filled in directly when the patient arrived or by telephone)

Drug: Mirabegron 50 MG

Placebo

PLACEBO COMPARATOR

The participants were given a placebo that was started 3 days before DJ stent insertion and until 6 weeks after the DJ stent insertion and filled in USSQ every week until 6 weeks after the DJ stent insertion(filled in directly when the patient arrives or by telephone)

Drug: Mirabegron 50 MG

Interventions

Mirabegron 50 MG DRUG

The participants were given mirabegron 50 mg or tamsulosin 0.4 mg and filled in the Ureteral Stent Symptom Questionnaire (USSQ), filled in directly when the patient arrived or by telephone.

Also known as: Tamsulosin 0.4 mg, Placebo

Mirabegron; Placebo; Tamsulosin

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hasanuddin University: lead

Study Sites (1)

DR Wahidin Sudirohusodo Hospital, Hasanuddin University Hospital, and Akademis Jaury Jusuf Putra Hospital.

Makassar, South Sulawesi, 90245, Indonesia

Location

MeSH Terms

Conditions

Ureterolithiasis; Kidney Calculi; Lower Urinary Tract Symptoms

Interventions

mirabegron; Tamsulosin

Condition Hierarchy (Ancestors)

Ureteral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases; Nephrolithiasis; Kidney Diseases; Urinary Calculi; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Urological Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Officials

• Muhammad A Palinrungi

  Hasanuddin University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: All medicines were placed in the same 3 boxes, which were held by the paramedics so that the patients and paramedics did not know the allocation of the types of drugs given.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Division of Urology, Department of Surgery, Faculty of Medicine

Model Details: Patients will be divided into 3 groups of drug administration: Group A, Group B, and Group C.

Study Record Dates

• First Submitted: September 2, 2023
• First Posted: November 9, 2023
• Study Start: July 1, 2022
• Primary Completion: September 30, 2022
• Study Completion: October 30, 2022
• Last Updated: November 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)