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NCT Number: NCT06966804

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

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 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.

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Key information

Conditions

Stent Related Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sultanah Bahiyah Hospital, Alor Setar, Alor Star, Kedah, Malaysia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Terazosin

Drug

Subject will complete 14-day course of Terazosin

Tamsulosin

Drug

Subject will complete 14-day course of Tamsulosin

Primary outcomes

  1. To determine the efficacy of Terazosin, Tamsulosin and standard of care in reducing post-stenting urinary symptoms

    Time frame: From randomization to the end of the treatment at 14 days

    Ureteral Stent Symptom Questionnaire (USSQ)- "Urinary Symptom score" domain. This domain focuses on issues related to urine storage and voiding, including symptoms such as weak stream, intermittent, incomplete empty, straining to start, frequency of spasm, urgency, nocturia, dysuria, hematuria, urge incontinence and impact quality of life.

    Each symptom is scored, with higher score indicating more severe symptoms. The total score ranges from 11 ( best outcome) to 56 (worst outcome).

Secondary outcomes

  1. 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

    Time frame: From randomization to the end of the treatment at 14 days

    Ureteral Stent Symptom Questionnaire (USSQ) Domains

    Higher scores indicate worse outcomes across all domains:

    • Body Pain Score: Assesses pain in loin/flank, hypochondrium, groin, bladder, external genitalia, and kidney area during voiding/activity.
    • General Health: Evaluates physical symptoms, vitality, psychosocial impact, dependence on others, social life enjoyment, and activity limitations.
    • Work Performance: Measures absenteeism, productivity loss, concentration issues, functional limitations and overall work quality.
    • Sexual Matters: Assesses pain during intercourse, satisfaction, and complete sexual dysfunction.
    • Additional Problems: Identifies post-insertion complications.
    • Global Quality of life with stent in situ: Determines willingness for future stenting, reflecting overall tolerance.

  2. To describe the difference in adverse events

    Time frame: From randomization to the end of the treatment at 14 days

    Collect adverse events and serious adverse events

Study contacts

Contact information is provided by the study sponsor or research team.

Yeon Wee Ooi

CONTACT

[email protected]

6042225333

Sponsors and collaborators

Lead sponsor

Penang Hospital, Malaysia

Other Gov

Registry information

Official study title

Efficacy of Alpha Blockers (Terazosin vs Tamsulosin) in Reducing Ureteral Stent Related Symptoms - An Open-label, Randomized Controlled Trial

Acronym: TRAM

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 13, 2025
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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