Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2025-12-30 @ 9:05 PM
Study NCT ID:
NCT06966804
Status:
RECRUITING
Last Update Posted:
2025-09-05
First Post:
2025-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Alpha Blockers (Terazosin and Tamsulosin) in Reducing Ureteral Stent Related Symptoms
Sponsor:
Penang Hospital, Malaysia
Organization:
Study Overview
Official Title:
Efficacy of Alpha Blockers (Terazosin vs Tamsulosin) in Reducing Ureteral Stent Related Symptoms - An Open-label, Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRAM
Brief 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.
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| RSCH ID-24-05599-H07 | OTHER | National Medical Research Registry | View |