Comparison of Alpha Blockers (Terazosin and Tamsulosin) in Reducing Ureteral Stent Related Symptoms

Last updated: August 28, 2025
Sponsor: Penang Hospital, Malaysia
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

Tamsulosin

Terazosin

Clinical Study ID

NCT06966804
NMRR-24-03594-URB
RSCH ID-24-05599-H07
  • Ages > 18
  • All Genders

Study 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

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 foruncomplicated ureteric or renal calculi

Exclusion

Exclusion Criteria:

  1. Known comorbidity that increase the risk of complication

  2. Prostate pathology: Benign prostate hyperplasia, prostatitis, prostaticcarcinoma

  3. Bladder pathology: Bladder tumor, stone, overactive bladder

  4. Ureteral abnormality/ trauma, urethral stricture

  5. Concomitant urinary tract infection

  6. Orthostatic hypotension

  7. Solitary kidney

  8. Previous pelvic/ gynaecological surgery

  9. Patient is concomitantly receiving treatment from a pain clinic for chronic painmanagement.

  10. Pregnancy (for women of childbearing potential)

  11. Known history of allergic reactions to tamsulosin or terazosin

  12. Patient is concomitantly taking warfarin or H2 receptor blockers

  13. Patients with clinical condition(s) judged by the researcher/ clinician to beunsuitable for participation in the study

Study Design

Total Participants: 150
Treatment Group(s): 2
Primary Treatment: Tamsulosin
Phase: 3
Study Start date:
June 01, 2025
Estimated Completion Date:
May 31, 2026

Connect with a study center

  • Sultanah Bahiyah Hospital, Alor Setar

    Alor Star 1736309, Kedah 1733048 05460
    Malaysia

    Active - Recruiting

  • Hospital Pulau Pinang

    George Town, Pulau Pinang 10450
    Malaysia

    Site Not Available

  • Hospital Pulau Pinang

    George Town 1735106, Pulau Pinang 1733047 10450
    Malaysia

    Active - Recruiting

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