Clinical trial NCT06966804: Comparison of Alpha Blockers (Terazosin and Tamsulosin) in Reducing Ureteral Stent Related Symptoms
Official title: Efficacy of Alpha Blockers (Terazosin vs Tamsulosin) in Reducing Ureteral Stent Related Symptoms - An Open-label, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Stent Related Symptoms
Keywords: alpha blockers
ureteral stent-related symptoms
tamsulosin
terazosin
USSQ
Lead sponsor: Penang Hospital, Malaysia
Sponsor class: OTHER_GOV
First posted: 2025-05-13
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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:

1. Terazosin (alpha-blocker) for 14 days
2. Tamsulosin (alpha-blocker) for 14 days
3. 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 criteria: Inclusion Criteria:

1. Malaysian age 18 years old and above.
2. Able to provide written informed consent to participate in the trial.
3. Willing to comply with study procedures.
4. Unilateral intracorporeal lithotripsy procedure with ureteral stent placement for uncomplicated ureteric or renal calculi

Exclusion Criteria:

1. Known comorbidity that increase the risk of complication

   1. Prostate pathology: Benign prostate hyperplasia, prostatitis, prostatic carcinoma
   2. Bladder pathology: Bladder tumor, stone, overactive bladder
   3. Ureteral abnormality/ trauma, urethral stricture
   4. Concomitant urinary tract infection
   5. Orthostatic hypotension
   6. Solitary kidney
2. Previous pelvic/ gynaecological surgery
3. Patient is concomitantly receiving treatment from a pain clinic for chronic pain management.
4. Pregnancy (for women of childbearing potential)
5. Known history of allergic reactions to tamsulosin or terazosin
6. Patient is concomitantly taking warfarin or H2 receptor blockers
7. Patients with clinical condition(s) judged by the researcher/ clinician to be unsuitable for participation in the study

Primary outcomes:
measure: To determine the efficacy of Terazosin, Tamsulosin and standard of care in reducing post-stenting urinary symptoms
timeFrame: From randomization to the end of the treatment at 14 days
Secondary outcomes:
measure: To determine the difference in analgesic requirement
timeFrame: From randomization to the end of the treatment at 14 days
measure: To determine the efficacy of Terazosin, Tamsulosin and standard of care in reducing post-stenting: Body pain, General health Work performance, Sexual matters, Additional problems
timeFrame: From randomization to the end of the treatment at 14 days
measure: To describe the difference in adverse events
timeFrame: From randomization to the end of the treatment at 14 days
Other outcomes:
Locations:
city: George Town
country: Malaysia
facility: Hospital Pulau Pinang
state: Pulau Pinang
Study officials:
References: