Comparison of Alpha Blockers (Terazosin and Tamsulosin) in Reducing Ureteral Stent Related Symptoms
Recruiting
Phase 3Interventional Study
Stent Related Symptoms
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
150 (estimated)
Sponsor
Penang Hospital, Malaysia · Government
Who this trial is looking for
This trial is looking for adults in Malaysia who are 18 years or older and have recently had a procedure to remove kidney stones, resulting in a stent being placed. However, it’s not for people with certain health issues like prostate problems, urinary infections, or those who are pregnant. They also can’t be taking specific medications that might cause complications.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 d…
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.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
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 calc…
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
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.