A Phase 4 interventional study of Tamsulosin and Tadalafil in Acute Urinary Retention, Benign Prostatic Hyperplasia and Benign Prostatic Obstruction, 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 2026-06-17.
Sponsored by Beni-Suef University · Phase 4, Interventional, and Treatment
Among 26 studies testing tadalafil in Prostatic Hyperplasia — 2 open to participants now, 2 under way, none of them phase 3. Tadalafil · Prostatic Hyperplasia.
Among the 26 studies testing tadalafil in Prostatic Hyperplasia, this one is the 11th largest by planned enrollment, is one of 2 that started in 2026, is one of 6 in phase 4, and was the 25th registered.
828 studies on the registry are indexed under Prostatic Hyperplasia; 179 are open to participants now.
Browse Prostatic Hyperplasia studies →2 of the 26 studies testing tadalafil in Prostatic Hyperplasia are open now, in 1 country. Recruiting first, the newest first:
Assiut University
Men only
By country, each count listing its studies:
Tadalafil: first FDA approval 2003 (CIALIS), first EMA approval 2002. 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.
26 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 5 · Phase 3 11 · Phase 4 6
First in 2004; this study’s year is marked. 2 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 320 is above the median of 92 across 627 interventional studies indexed under Prostatic Hyperplasia.
Median enrollment 258 across the 26 interventional studies. Of the 23 that completed or were terminated, 15 (65%) have results posted.
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20 of 26 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 is the 2nd largest by planned enrollment, is one of 4 that started in 2026, is one of 3 in phase 4, and was the 10th registered.
Beni-Suef University’s Prostatic Hyperplasia studies by the year they started, since 2015.
1 of the studies testing tadalafil in Prostatic Hyperplasia that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07654413Beni-Suef UniversityTamsulosin With or Without Tadalafil for Trial Without Catheter After Acute Urinary Retention Due to Benign Prostatic Hyperplasia | 2027-11 |
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Among the 26 studies testing tadalafil in Prostatic Hyperplasia, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Beni-Suef University’s 11 in Prostatic Hyperplasia:
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Acute urinary retention is a common emergency in men with benign prostatic hyperplasia. After bladder drainage with a urethral catheter, patients usually undergo a trial without catheter to determine whether they can pass urine again without recatheterization.
This study will evaluate whether adding tadalafil 5 mg once daily to tamsulosin 0.4 mg once daily improves the chance of successful trial without catheter in men with first-episode acute urinary retention due to presumed benign prostatic hyperplasia.
Participants will be randomly assigned to receive either tamsulosin plus tadalafil or tamsulosin plus a matching placebo. Study medication will start within 24 hours after catheterization. The catheter will be removed on Day 7. If the first trial without catheter fails, the catheter will be reinserted and a second rescue trial without catheter will be performed on Day 14.
The main outcome is overall catheter-free success by Day 14. Participants will also be followed for recurrent urinary retention, post-void residual urine, urinary flow, catheter-related complications, drug-related adverse events, and the need for benign prostatic hyperplasia-related surgery within 3 months.
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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive tamsulosin 0.4 mg once daily plus a matching placebo once daily. Treatment will start within 24 hours after urethral catheterization and continue until the Day-7 trial without catheter. Participants who fail the Day-7 trial without catheter will continue the assigned treatment until the rescue trial without catheter on Day 14.
Drug: Tamsulosin · Drug: Tadalafil Placebo
Participants will receive tamsulosin 0.4 mg once daily plus tadalafil 5 mg once daily. Treatment will start within 24 hours after urethral catheterization and continue until the Day-7 trial without catheter. Participants who fail the Day-7 trial without catheter will continue the assigned treatment until the rescue trial without catheter on Day 14.
Drug: Tamsulosin · Drug: Tadalafil
Tamsulosin 0.4 mg will be administered orally once daily as open-label background therapy in both study arms. Treatment will start within 24 hours after urethral catheterization and continue until the scheduled Day-7 trial without catheter. Participants who fail the Day-7 trial without catheter will continue treatment until the rescue trial without catheter on Day 14.
Tadalafil 5 mg will be administered orally once daily in the experimental arm in addition to open-label tamsulosin 0.4 mg once daily. Treatment will start within 24 hours after urethral catheterization and continue until the scheduled Day-7 trial without catheter. Participants who fail the Day-7 trial without catheter will continue treatment until the rescue trial without catheter on Day 14.
A matching placebo tablet will be administered orally once daily in the placebo comparator arm in addition to open-label tamsulosin 0.4 mg once daily. The placebo will be identical to tadalafil in appearance, packaging, and labeling to maintain blinding.
Overall Catheter-Free Success by Day 14
Proportion of participants who achieve successful spontaneous voiding after either the scheduled Day-7 trial without catheter or the rescue Day-14 trial without catheter. Success is defined as spontaneous voiding after catheter removal, voided volume of at least 100 mL, post-void residual urine less than 150 mL measured within 10-15 minutes after voiding, no recatheterization within 24 hours after the relevant trial without catheter attempt, and remaining catheter-free until Day 14 for participants who initially pass the Day-7 trial without catheter.
Time frame: Day 14
Successful Day-7 Trial Without Catheter
Proportion of participants who achieve successful spontaneous voiding after catheter removal on Day 7. Success is defined as spontaneous voiding, voided volume of at least 100 mL, post-void residual urine less than 150 mL measured within 10-15 minutes after voiding, and no recatheterization within 24 hours.
Time frame: Day 7
Successful Rescue Day-14 Trial Without Catheter Among Day-7 Failures
Proportion of participants who fail the Day-7 trial without catheter and subsequently achieve successful rescue trial without catheter on Day 14 using the same predefined success criteria: spontaneous voiding, voided volume of at least 100 mL, post-void residual urine less than 150 mL measured within 10-15 minutes after voiding, and no recatheterization within 24 hours.
Time frame: Day 14
Recurrent Acute Urinary Retention Within 30 Days
Proportion of participants who develop recurrent painful acute urinary retention requiring recatheterization within 30 days after randomization.
Time frame: 30 days
Need for Benign Prostatic Hyperplasia-Related Surgery Within 3 Months
Proportion of participants who require surgical intervention for benign prostatic hyperplasia or benign prostatic obstruction within 3 months after randomization.
Time frame: 3 months
Plan to share: No — Individual participant data will not be shared publicly because the study includes individual-level urological and treatment-related clinical data, and participant-level data sharing is not currently included in the ethics approval or informed consent. 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, and an appropriate data-sharing agreement.
No publications or documents are linked to this record.
Started Jun 2026 (actual). Primary completion is estimated for Nov 2027, 17 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 17 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 drug tested here: Tadalafil