A Phase 4 interventional study of Tamsulosin 0.4 mg and Tamsulosin 0.8 mg in Acute Urinary Retention and Benign Prostatic Hyperplasia, sponsored by Beni-Suef University. Recruiting at 1 site in Egypt. Open to male participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-06-16.
Sponsored by Beni-Suef University · Phase 4, Interventional, and Treatment
Among 48 studies testing tamsulosin in Prostatic Hyperplasia — 8 open to participants now, 8 under way, 1 of them phase 3. Tamsulosin · Prostatic Hyperplasia.
Among the 48 studies testing tamsulosin in Prostatic Hyperplasia, this one is the 15th largest by planned enrollment, is one of 6 that started in 2026, is one of 17 in phase 4, and was the 43rd registered.
828 studies on the registry are indexed under Prostatic Hyperplasia; 179 are open to participants now.
Browse Prostatic Hyperplasia studies →8 of the 48 studies testing tamsulosin in Prostatic Hyperplasia are open now, in 3 countries. Recruiting first, the newest first:
Ain Shams University · Sites in Egypt
Ages 45+
Ankara Training and Research Hospital · Sites in Turkey
Ages 40–85 · Men only
Azienda Ospedaliero Universitaria Maggiore della Carita · Sites in Italy
Ages 40+ · Men only · Healthy volunteers
Il-Yang Pharm. Co., Ltd.
Ages 45+ · Men only
Mohsen Pourazizi
Ages 50+ · Men only
By country, each count listing its studies:
Tamsulosin: first FDA approval 1997 (FLOMAX). What it is approved for, and how studies give it, is on its page →
Of the 102 Prostatic Hyperplasia studies recruiting now, 70 (69%) set no upper age limit and 4 (4%) stop at 75 or younger; 7 take children under 18; 7 take healthy volunteers.
This study: 50 Years and older · male · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
48 studies; the count open now beside each. This study's row is marked.
First in 1998; this study’s year is marked. 6 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 378 is above the median of 92 across 627 interventional studies indexed under Prostatic Hyperplasia.
Median enrollment 118 across the 48 interventional studies. Of the 35 that completed or were terminated, 12 (34%) have results posted.
This tab as a report to print or save as PDF → With an account.
29 of 48 have an industry lead sponsor. The 10 most frequent:
Beni-Suef University is the lead sponsor of 349 studies on the registry; 123 are open to participants now.
11 studies in Prostatic Hyperplasia by Beni-Suef University: 5 open now, 5 under way, none of them phase 3. Of 6 finished, 0 (0%) have results posted.
Among the 11 studies in Prostatic Hyperplasia by Beni-Suef University, this one has the largest planned enrollment, is one of 4 that started in 2026, is one of 3 in phase 4, and was the 9th registered.
Beni-Suef University’s Prostatic Hyperplasia studies by the year they started, since 2015.
5 of the studies testing tamsulosin in Prostatic Hyperplasia that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07870759Phase 3Il-Yang Pharm. Co., Ltd.Efficacy and Safety of Combination Therapy Compared With Monotherapy in Patients With Benign Prostatic Hyperplasia | 2027-08-31 |
| NCT07722884Ain Shams UniversityTamsulosin Monotherapy Versus Combination Therapy With Tadalafil (2.5 mg vs 5 mg) in Managing Male LUTS Secondary to BPH | 2027-01-01 |
| NCT07743034Mohsen PouraziziIris Structural Changes With Tamsulosin vs. Silodosin in Benign Prostatic Hyperplasia Patients | 2027-04 |
| NCT07743060Mohsen PouraziziPupil Size and Choroidal Thickness Changes With Tamsulosin vs. Silodosin in Benign Prostatic Hyperplasia Patients | 2027-04 |
| NCT07650968Beni-Suef UniversityTamsulosin Dose Escalation or Silodosin Switch Before Trial Without Catheter in BPH-Related Acute Urinary Retention | 2027-05 |
Add all 5 to your calendar (.ics) → With an account.
Among the 48 studies testing tamsulosin in Prostatic Hyperplasia, from their registry updates:
Among Beni-Suef University’s 11 in Prostatic Hyperplasia:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will continue tamsulosin 0.4 mg once daily for 7 days during urethral catheterization before Trial Without Catheter at Day 7.
Drug: Tamsulosin 0.4 mg
Participants will receive tamsulosin 0.8 mg once daily for 7 days during urethral catheterization before Trial Without Catheter at Day 7.
Drug: Tamsulosin 0.8 mg
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.
Drug: Silodosin 8 mg
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.
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.
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.
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.
Time frame: Day 7, with assessment continuing for 24 hours after catheter removal
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.
Time frame: Day 14
Recurrent Acute Urinary Retention Within 30 Days
Proportion of participants who develop recurrent acute urinary retention requiring re-catheterization after initially successful Trial Without Catheter.
Time frame: 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.
Time frame: Up to 30 days
Plan to share: No — 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.
No publications or documents are linked to this record.
Started Jun 2026 (actual). Primary completion is estimated for May 2027, 11 months after the start.
Of 28 phase 4 interventional studies under Prostatic Hyperplasia, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 26. This study's planned 11 months is below that.
How these figures are worked out, and which studies are left out of them.
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Studies of the drugs tested here: Tamsulosin · Silodosin