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| ID | Type | Description | Link |
|---|---|---|---|
| RSCH ID-24-05599-H07 | Other Identifier | National Medical Research Registry |
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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:
After stent placement, subjects will be randomly assigned to one of three groups:
Follow-Up:
End of study: Final phone call to check for any additional side effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Terazosin | Experimental | Terazosin 2mg ON |
|
| Tamsulosin | Experimental | Tamsulosin 0.4mg ON |
|
| Standard care | No Intervention | No medication |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Terazosin | Drug | Subject will complete 14-day course of Terazosin |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | From randomization to the end of the treatment at 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the difference in analgesic requirement | Analgesic usage from patient's analgesic diary. Patients will be discharged with a standardized institutional analgesic regimen. Daily analgesic use will be recorded in a patient diary, and total consumption will be calculated at the end of the treatment period. The total analgesic dose will be compared across the three study arms. A higher total analgesic requirement will indicate more severe stent-related symptoms. |
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Inclusion Criteria:
Exclusion Criteria:
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
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yeon Wee Ooi | Contact | 6042225333 | raymondooi09@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sultanah Bahiyah Hospital, Alor Setar | Recruiting | Alor Star | Kedah | 05460 | Malaysia |
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| ID | Term |
|---|---|
| C041226 | Terazosin |
| D000077409 | Tamsulosin |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| Tamsulosin |
| Drug |
Subject will complete 14-day course of Tamsulosin |
|
| From randomization to the end of the treatment at 14 days |
| 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:
| 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 | From randomization to the end of the treatment at 14 days |
| Hospital Pulau Pinang | Recruiting | George Town | Pulau Pinang | 10450 | Malaysia |
|
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |