Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2025-12-24 @ 4:32 PM
NCT ID:
NCT06124066
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06124066
Study Brief:
Protocol Section:
NCT06124066