Status:
COMPLETED
THE EFFECTS OF MIRABEGRON AND TAMSULOSIN FOR PATIENTS WITH URETERAL STENTS
Lead Sponsor:
Hasanuddin University
Conditions:
Ureteral Stone
Kidney Stones
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 u...
Detailed Description
The research design used was experimental with randomized sampling, double-blinded, in men and women with ureteral stents. The patient signed informed consent regarding blood and urine sampling, bladd...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2022
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT06124066
Start Date
July 1 2022
End Date
October 30 2022
Last Update
November 13 2023
Active Locations (1)
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1
DR Wahidin Sudirohusodo Hospital, Hasanuddin University Hospital, and Akademis Jaury Jusuf Putra Hospital.
Makassar, South Sulawesi, Indonesia, 90245