Comparison of Alpha Blockers (Terazosin and Tamsulosin) in Reducing Ureteral Stent Related Symptoms
NCT ID: NCT06966804
Last Updated: 2025-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
150 participants
INTERVENTIONAL
2025-06-01
2026-05-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Terazosin
Terazosin 2mg ON
Terazosin
Subject will complete 14-day course of Terazosin
Tamsulosin
Tamsulosin 0.4mg ON
Tamsulosin
Subject will complete 14-day course of Tamsulosin
Standard care
No medication
No interventions assigned to this group
Interventions
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Terazosin
Subject will complete 14-day course of Terazosin
Tamsulosin
Subject will complete 14-day course of Tamsulosin
Eligibility Criteria
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Inclusion Criteria
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. 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
18 Years
ALL
No
Sponsors
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Penang Hospital, Malaysia
OTHER_GOV
Responsible Party
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Ooi Yeon Wee
Doctor
Locations
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Sultanah Bahiyah Hospital, Alor Setar
Alor Star, Kedah, Malaysia
Hospital Pulau Pinang
George Town, Pulau Pinang, Malaysia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RSCH ID-24-05599-H07
Identifier Type: OTHER
Identifier Source: secondary_id
NMRR-24-03594-URB
Identifier Type: -
Identifier Source: org_study_id
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