Stent Related SymptomsPhase 3TRAMNCT06966804
Comparison of Alpha Blockers (Terazosin and Tamsulosin) in Reducing Ureteral Stent Related Symptoms
A Phase 3 study testing Terazosin and Tamsulosin in people with Stent Related Symptoms, run by Penang Hospital, Malaysia at 2 sites in Malaysia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stent Related Symptoms
- What is being tested?
- Terazosin and Tamsulosin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesMalaysia
- Study dates
- 1 Jun 2025to 31 Jul 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia2 sites, 2 recruiting
- Recruiting
Sultanah Bahiyah Hospital, Alor Setar
Alor Star, Kedah, 05460
Yeon Wee Ooi, Medical Degree, 04-740 6233, raymondooi09@gmail.com
- Recruiting
Hospital Pulau Pinang
George Town, Pulau Pinang, 10450
Yeon Wee Ooi, Medical Degree, 6042225333, raymondooi09@gmail.com
Yeon Wee Ooi
About this study
Official title: Efficacy of Alpha Blockers (Terazosin vs Tamsulosin) in Reducing Ureteral Stent Related Symptoms - An Open-label, Randomized Controlled 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:
Read more
- 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:
- Terazosin (alpha-blocker) for 14 days
- Tamsulosin (alpha-blocker) for 14 days
- 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.
- Conditions
- Stent Related Symptoms
- Being tested
- Terazosin, Tamsulosin
- Keywords
- alpha blockers, ureteral stent-related symptoms, tamsulosin, terazosin, USSQ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TerazosinDrug
Subject will complete 14-day course of Terazosin
TamsulosinDrug
Subject will complete 14-day course of Tamsulosin
| Study group | Role | What they receive |
|---|---|---|
| Terazosin | Experimental | Terazosin 2mg ON Receives: Drug: Terazosin |
| Tamsulosin | Experimental | Tamsulosin 0.4mg ON Receives: Drug: Tamsulosin |
| Standard care | No intervention | No medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From randomization to the end of the treatment at 14 days
Secondary outcomes (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:
- Body Pain Score: Assesses pain in loin/flank, hypochondrium, groin, bladder, external genitalia, and kidney area during voiding/activity.
- General Health: Evaluates physical symptoms, vitality, psychosocial impact, dependence on others, social life enjoyment, and activity limitations.
- Work Performance: Measures absenteeism, productivity loss, concentration issues, functional limitations and overall work quality.
- Sexual Matters: Assesses pain during intercourse, satisfaction, and complete sexual dysfunction.
- Additional Problems: Identifies post-insertion complications.
- Global Quality of life with stent in situ: Determines willingness for future stenting, reflecting overall tolerance.
Measured: From randomization to the end of the treatment at 14 days
To describe the difference in adverse events
Collect adverse events and serious adverse events
Measured: From randomization to the end of the treatment at 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start1 Jun 2025
- Primary completion31 May 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stent Related SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Penang Hospital, Malaysia
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ooi Yeon Wee, Penang Hospital, Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06966804
- Sponsor's protocol ID
- NMRR-24-03594-URB
- Other IDs
- RSCH ID-24-05599-H07
- Acronym
- TRAM
- Status last verified
- Aug 2025
- First submitted
- 4 May 2025
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Alpha Blockers (Terazosin vs Tamsulosin) in Reducing Ureteral Stent Related Symptoms - An Open-label, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06966804
- Acronym / sponsor ID
- TRAM / NMRR-24-03594-URB
- Conditions
- Stent Related Symptoms
- Keywords
- alpha blockers, ureteral stent-related symptoms, tamsulosin, terazosin, USSQ
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Penang Hospital, MalaysiaOther government
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 13 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Terazosin (alpha-blocker) for 14 days
- Tamsulosin (alpha-blocker) for 14 days
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Terazosin | Experimental | Drug: TerazosinTerazosin 2mg ON |
| Tamsulosin | Experimental | Drug: TamsulosinTamsulosin 0.4mg ON |
| Standard care | No intervention | –No medication |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- Known comorbidity that increase the risk of complication
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TerazosinSubject will complete 14-day course of Terazosin | Drug | Terazosin |
| TamsulosinSubject will complete 14-day course of Tamsulosin | Drug | Tamsulosin |
Primary outcome
To determine the efficacy of Terazosin, Tamsulosin and standard of care in reducing post-stenting urinary symptoms
Time frame: From randomization to the end of the treatment at 14 days
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).
2 secondary outcomes
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
Time frame: From randomization to the end of the treatment at 14 days
To describe the difference in adverse events
Time frame: From randomization to the end of the treatment at 14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Terazosin and Tamsulosin in people with Stent Related Symptoms, run by Penang Hospital, Malaysia at 2 sites in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yeon Wee Ooi (6042225333, raymondooi09@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the efficacy of Terazosin, Tamsulosin and standard of care in reducing post-stenting urinary symptoms (time frame: From randomization to the end of the treatment at 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.