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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorPenang Hospital, Malaysia

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Terazosin

    Drug

    Subject will complete 14-day course of Terazosin

  • Tamsulosin

    Drug

    Subject will complete 14-day course of Tamsulosin

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: TerazosinExperimental treatment 1 intervention
Group B: TamsulosinExperimental treatment 1 intervention
Group C: Standard careNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

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).

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

Secondary outcomes

1

To determine the difference in analgesic requirement

Analgesic usage from patient's analgesic diary. Patients will be discharged with a standardized institutional analgesic regimen. Daily analgesic use will be recorded in a patient diary, and total consumption will be calculated at the end of the treatment period. The total analgesic dose will be compared across the three study arms. A higher total analgesic requirement will indicate more severe stent-related symptoms.

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

Ureteral Stent Symptom Questionnaire (USSQ) Domains Higher scores indicate worse outcomes across all domains: 1. Body Pain Score: Assesses pain in loin/flank, hypochondrium, groin, bladder, external genitalia, and kidney area during voiding/activity. 2. General Health: Evaluates physical symptoms, vitality, psychosocial impact, dependence on others, social life enjoyment, and activity limitations. 3. Work Performance: Measures absenteeism, productivity loss, concentration issues, functional limitations and overall work quality. 4. Sexual Matters: Assesses pain during intercourse, satisfaction, and complete sexual dysfunction. 5. Additional Problems: Identifies post-insertion complications. 6. Global Quality of life with stent in situ: Determines willingness for future stenting, reflecting overall tolerance.

Time frame
From randomization to the end of the treatment at 14 days
3

To describe the difference in adverse events

Collect adverse events and serious adverse events

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

Other outcomes

Sponsors and contacts

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