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This randomized controlled trial will compare three medication strategies before trial without catheter in men with acute urinary retention due to benign prostatic hyperplasia who were already taking tamsulosin 0.4 mg once daily before the retention episode. After urethral catheterization, eligible participants will be randomly assigned to one of three groups for 7 days: continuation of tamsulosin 0.4 mg once daily, escalation to tamsulosin 0.8 mg once daily, or switching to silodosin 8 mg once daily. The urethral catheter will be removed on Day 7, and the ability to void successfully without re-catheterization will be assessed. Follow-up will continue to Day 30, with additional recording of catheter-free status, recurrent urinary retention, urinary flow, post-void residual urine, symptom scores, adverse drug events, catheter-related complications, and the need for later benign prostatic hyperplasia-related surgery.
Acute urinary retention is a common emergency complication of benign prostatic hyperplasia. Standard management includes immediate bladder decompression by urethral catheterization followed by alpha-blocker therapy before attempting catheter removal. However, the optimal management strategy is unclear in men who develop acute urinary retention despite already receiving standard-dose tamsulosin 0.4 mg once daily.
This trial is designed to evaluate whether continuing tamsulosin 0.4 mg, increasing the dose to tamsulosin 0.8 mg, or switching to silodosin 8 mg provides better clinical outcomes before trial without catheter. Eligible men aged 50 years or older with painful acute urinary retention presumed to be secondary to benign prostatic enlargement or obstruction, and who were already taking tamsulosin 0.4 mg once daily for at least 4 weeks before the retention episode, will be enrolled after successful urethral catheterization and written informed consent.
Participants will be randomized in a 1:1:1 ratio to one of three parallel treatment arms. The assigned medication will be given for 7 days while the urethral catheter remains in place. On Day 7, the catheter will be removed in the outpatient urology clinic. Trial without catheter success will be assessed using a predefined clinical definition based on spontaneous voiding, voided volume, post-void residual urine measured by ultrasound, absence of clinically significant voiding difficulty, and no need for re-catheterization within 24 hours.
Participants will be followed until Day 30 for urinary outcomes and safety assessment. The study will also record adverse drug events and catheter-related complications. Participants who fail the Day-7 trial without catheter will be managed according to standard clinical care, including re-catheterization and possible rescue trial without catheter or further benign prostatic hyperplasia management according to clinical judgment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tamsulosin 0.4 mg Continuation | Active Comparator | Participants will continue tamsulosin 0.4 mg once daily for 7 days during urethral catheterization before Trial Without Catheter at Day 7. |
|
| Tamsulosin 0.8 mg Dose Escalation | Experimental | Participants will receive tamsulosin 0.8 mg once daily for 7 days during urethral catheterization before Trial Without Catheter at Day 7. |
|
| Switch to Silodosin 8 mg | Experimental | Participants will stop tamsulosin 0.4 mg and switch to silodosin 8 mg once daily for 7 days during urethral catheterization before Trial Without Catheter at Day 7. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tamsulosin 0.4 mg | Drug | Participants assigned to this intervention will continue tamsulosin 0.4 mg once daily for 7 days during urethral catheterization before Trial Without Catheter at Day 7. |
| Measure | Description | Time Frame |
|---|---|---|
| Successful Trial Without Catheter at Day 7 | Proportion of participants with successful Trial Without Catheter at Day 7. Success is defined as spontaneous voiding within 6 hours after urethral catheter removal, voided volume ≥100 mL, post-void residual urine <150 mL measured by ultrasound within 10-15 minutes after voiding, no painful bladder distension or clinically significant voiding difficulty requiring immediate re-catheterization, and no need for re-catheterization within 24 hours after catheter removal. | Day 7, with assessment continuing for 24 hours after catheter removal |
| Measure | Description | Time Frame |
|---|---|---|
| Catheter-Free Status at Day 14 | Proportion of participants who are free from an indwelling urinary catheter at Day 14 after randomization, including participants who undergo rescue Trial Without Catheter after initial Day-7 failure. | Day 14 |
| Recurrent Acute Urinary Retention Within 30 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hany F Badawy, MD | Contact | +201149525028 | HANYFATHY86@GMAIL.COM | |
| Mohamed M Dogha, MD | Contact | +20 10 10044612 | mma16@fayoum.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Urology- Beni-Suef University Hospitals | Recruiting | Banī Suwayf | Beni Suweif Governorate | 02456 | Egypt |
Individual participant data will not be shared because the study includes individual-level clinical data related to acute urinary retention, medication exposure, catheterization, follow-up outcomes, and adverse events. Only aggregated, de-identified results will be reported in publications or presentations. Any future sharing of de-identified participant-level data would require additional approval from the Research Ethics Committee, Faculty of Medicine, Beni-Suef University.
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Participants will be randomized in a 1:1:1 ratio to one of three parallel treatment arms for 7 days during urethral catheterization before Trial Without Catheter at Day 7: continuation of tamsulosin 0.4 mg once daily, escalation to tamsulosin 0.8 mg once daily, or switching to silodosin 8 mg once daily.
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The outcomes assessor evaluating Trial Without Catheter outcome, post-void residual urine by ultrasound, and uroflowmetry will be blinded to treatment allocation.
| Tamsulosin 0.8 mg | Drug | Participants assigned to this intervention will receive tamsulosin 0.8 mg once daily for 7 days during urethral catheterization before Trial Without Catheter at Day 7. |
|
| Silodosin 8 mg | Drug | Participants assigned to this intervention will stop tamsulosin 0.4 mg and switch to silodosin 8 mg once daily for 7 days during urethral catheterization before Trial Without Catheter at Day 7. |
|
Proportion of participants who develop recurrent acute urinary retention requiring re-catheterization after initially successful Trial Without Catheter. |
| Up to 30 days |
| Adverse Drug Events | Proportion of participants with adverse drug events, including dizziness, postural hypotension, syncope, headache, nasal congestion, abnormal ejaculation, diarrhea, allergic reaction, or other clinically significant drug-related adverse events. | Up to 30 days |
| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D000077409 | Tamsulosin |
| C095285 | silodosin |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
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