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

Penang Hospital, Malaysia

Status and phase: Begins enrollment this month; Phase 3

Conditions: Stent Related Symptoms

Treatments: Drug: Tamsulosin; Drug: Terazosin

Study type: Interventional

Funder types: Other

Identifiers

NCT06966804

RSCH ID-24-05599-H07 (Other Identifier)

NMRR-24-03594-URB

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

Terazosin

Experimental group

Description:

Terazosin 2mg ON

Treatment:

Drug: Terazosin

Tamsulosin

Experimental group

Description:

Tamsulosin 0.4mg ON

Treatment:

Drug: Tamsulosin

Standard care

No Intervention group

Description:

No medication