Comparing terazosin, tamsulosin, and no alpha-blocker for easing ureteral stent urinary symptoms

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

This compares taking terazosin or tamsulosin for 14 days versus usual care to see if they reduce urinary symptoms in adults who received a ureteral stent after stone removal.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Penang Hospital, Malaysia (Government)
• Locations: 2 sites (Alor Star, Kedah and 1 other locations)
• Trial ID: NCT06966804 on ClinicalTrials.gov

What this trial studies

Adults who receive a ureteral stent after unilateral intracorporeal lithotripsy are randomly assigned to 14 days of terazosin, 14 days of tamsulosin, or standard care with no alpha-blocker. Participants record painkiller use in a diary and complete the Ureteral Stent Symptom Questionnaire (USSQ) to measure urinary symptoms, body pain, general health, work performance, sexual matters, and additional problems. The trial also tracks side effects to compare safety between the two drugs and usual care. Sites for enrollment and follow-up are tertiary hospitals in Malaysia.

Who should consider this trial

Good fit: Adults (18+) in Malaysia who undergo unilateral intracorporeal lithotripsy with ureteral stent placement for uncomplicated ureteric or renal stones, can give informed consent, and meet medical eligibility criteria.

Not a fit: Patients with prostate or bladder pathology, ureteral abnormalities, urinary tract infection, orthostatic hypotension, solitary kidney, prior pelvic/gynaecological surgery, pregnancy, allergy to the study drugs, chronic pain clinic treatment, or on contraindicated medications (e.g., warfarin) are excluded and unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, one of the medications could reduce urinary discomfort and painkiller needs after stent placement, improving post-procedure quality of life.

How similar studies have performed: Prior trials of alpha-blockers such as tamsulosin for stent-related symptoms have shown mixed but sometimes positive results, so head-to-head comparisons remain useful.

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

Where this trial is running

Alor Star, Kedah and 1 other locations

• Sultanah Bahiyah Hospital, Alor Setar — Alor Star, Kedah, Malaysia (Recruiting)
• Hospital Pulau Pinang — George Town, Pulau Pinang, Malaysia (Recruiting)

Study contacts

• Study coordinator: Yeon Wee Ooi

Conditions Stent Related Symptoms; alpha blockers; ureteral stent-related symptoms; tamsulosin; terazosin; USSQ