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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат Terazosin
  Subject will complete 14-day course of Terazosin
• Препарат Tamsulosin
  Subject will complete 14-day course of Tamsulosin

Первичные конечные точки

• To determine the efficacy of Terazosin, Tamsulosin and standard of care in reducing post-stenting urinary symptoms [Срок оценки: From randomization to the end of the treatment at 14 days]

Вторичные конечные точки (2)

• 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 [Срок оценки: From randomization to the end of the treatment at 14 days]
• To describe the difference in adverse events [Срок оценки: From randomization to the end of the treatment at 14 days]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Малайзия · 2 центра

• Sultanah Bahiyah Hospital, Alor Setar — Alor Star
• Hospital Pulau Pinang — George Town

Идентификаторы

NCT: NCT06966804 · NMRR-24-03594-URB · RSCH ID-24-05599-H07

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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