Overview
The goal of this clinical trial is to compare how well Terazosin, Tamsulosin and standard care (no alpha-blocker) reduce urinary symptoms after ureteral stent placement. This trial also learn about the safety of these two study medications.
Main objective:
• To compare how well Terazosin, Tamsulosin and standard of care reduce post-stenting urinary symptoms.
Secondary objectives:
- To compare painkiller use among the groups.
- To assess differences in Body pain, General health, Work performance, Sexual matters, and Additional problems using a questionnaire (USSQ).
- To assess differences in side effects.
After stent placement, subjects will be randomly assigned to one of three groups:
- Terazosin (alpha-blocker) for 14 days
- Tamsulosin (alpha-blocker) for 14 days
- Standard of care (no alpha-blocker). All subjects will be discharged with standard pain-killers and a diary to track usage. Subjects in Terazosin and Tamsulosin groups will receive respective study medications to complete 14 days course of treatment.
Follow-Up:
- Day 7: A phone call will check medication use and any side effects.
- Day 15: Clinic visit for stent removal (standard practice). Subjects will complete the USSQ questionnaire, and medication compliance will be reviewed.
End of study: Final phone call to check for any additional side effects.
Eligibility
Inclusion Criteria:
- Malaysian age 18 years old and above.
- Able to provide written informed consent to participate in the trial.
- Willing to comply with study procedures.
- Unilateral intracorporeal lithotripsy procedure with ureteral stent placement for uncomplicated ureteric or renal calculi
Exclusion Criteria:
- Known comorbidity that increase the risk of complication
- Prostate pathology: Benign prostate hyperplasia, prostatitis, prostatic carcinoma
- Bladder pathology: Bladder tumor, stone, overactive bladder
- Ureteral abnormality/ trauma, urethral stricture
- Concomitant urinary tract infection
- Orthostatic hypotension
- Solitary kidney
- Previous pelvic/ gynaecological surgery
- Patient is concomitantly receiving treatment from a pain clinic for chronic pain management.
- Pregnancy (for women of childbearing potential)
- Known history of allergic reactions to tamsulosin or terazosin
- Patient is concomitantly taking warfarin or H2 receptor blockers
- Patients with clinical condition(s) judged by the researcher/ clinician to be unsuitable for participation in the study