Acute Urinary RetentionPhase 4TAMS-TAD-TWOCNCT07654413
Tamsulosin With or Without Tadalafil for Trial Without Catheter After Acute Urinary Retention Due to Benign Prostatic Hyperplasia
A Phase 4 study testing Tamsulosin and Tadalafil in people with Acute Urinary Retention and Benign Prostatic Hyperplasia, run by Beni-Suef University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Acute Urinary Retention, Benign Prostatic Hyperplasia, Benign Prostatic Obstruction
- What is being tested?
- Tamsulosin and Tadalafil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 320 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Jun 2026to Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male patient aged 50 years or older.
- First episode of spontaneous painful acute urinary retention.
- Successful urethral catheterization at presentation.
- Drained urine volume at presentation of at least 300 mL.
- Clinical impression of benign prostatic obstruction or benign prostatic hyperplasia based on history, digital rectal examination, and/or ultrasound evidence of enlarged prostate.
- Ability to provide written informed consent.
Who cannot join
- Previous episode of acute urinary retention.
- Chronic painless urinary retention phenotype.
- Active urinary tract infection or sepsis.
- Gross hematuria with clot retention.
- Suspected or known urethral stricture.
- Neurogenic bladder or major neurologic disease affecting voiding.
Show all 14Show fewer
- History of prostate cancer or bladder cancer.
- Previous prostate surgery.
- Current use of nitrates or guanylate cyclase stimulators.
- Contraindication to tadalafil or tamsulosin.
- Severe hypotension or unstable cardiovascular disease.
- Severe renal impairment.
- Severe hepatic impairment.
- Current or recent use of phosphodiesterase type 5 inhibitors before enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Department of Urology- Beni-Suef University Hospitals
Banī Suwayf, Beni Suweif Governorate, 02456
Hany F Badawy, MD, +201149525028, HANYFATHY86@GMAIL.COM
HANYFATHY86@GMAIL.COM
About this study
Official title: Tamsulosin With Versus Without Tadalafil for Trial Without Catheter After Acute Urinary Retention Due to Benign Prostatic Hyperplasia: A Prospective Double-Blind Randomized Trial
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.
Read more
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.
- Being tested
- Tamsulosin, Tadalafil, Tadalafil Placebo
- Keywords
- Trial Without Catheter, TWOC, Tamsulosin, Tadalafil, Benign Prostatic Hyperplasia
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TamsulosinDrug
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.
TadalafilDrug
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.
Tadalafil PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Tamsulosin Plus Placebo | Placebo comparator | 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. Receives: Drug: Tamsulosin; Drug: Tadalafil Placebo |
| Tamsulosin Plus Tadalafil | Experimental | 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. Receives: Drug: Tamsulosin; Drug: Tadalafil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 14
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start8 Jun 2026
- Primary completionNov 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Urinary RetentionStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1 ratio to one of two parallel treatment groups: tamsulosin 0.4 mg once daily plus tadalafil 5 mg once daily, or tamsulosin 0.4 mg once daily plus matching placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hany Fathy Badawy, MD, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07654413
- Sponsor's protocol ID
- BSU FMBSUREC07062026CBADAWY
- Acronym
- TAMS-TAD-TWOC
- Status last verified
- Jun 2026
- First submitted
- 12 Jun 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tamsulosin With Versus Without Tadalafil for Trial Without Catheter After Acute Urinary Retention Due to Benign Prostatic Hyperplasia: A Prospective Double-Blind Randomized Trial
- ClinicalTrials.gov ID
- NCT07654413
- Acronym / sponsor ID
- TAMS-TAD-TWOC / BSU FMBSUREC07062026CBADAWY
- Keywords
- Trial Without Catheter, TWOC, Tamsulosin, Tadalafil, Benign Prostatic Hyperplasia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 8 Jun 2026 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 17 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio to one of two parallel treatment groups: tamsulosin 0.4 mg once daily plus tadalafil 5 mg once daily, or tamsulosin 0.4 mg once daily plus matching placebo.
| Arm | Type | Receives |
|---|---|---|
| Tamsulosin Plus Placebo | Placebo comparator | Drug: Tamsulosin, Drug: Tadalafil PlaceboParticipants 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. |
| Tamsulosin Plus Tadalafil | Experimental | Drug: Tamsulosin, Drug: TadalafilParticipants 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male patient aged 50 years or older.
- First episode of spontaneous painful acute urinary retention.
- Successful urethral catheterization at presentation.
- Drained urine volume at presentation of at least 300 mL.
- Clinical impression of benign prostatic obstruction or benign prostatic hyperplasia based on history, digital rectal examination, and/or ultrasound evidence of enlarged prostate.
Key exclusion criteria (14 listed)
- Previous episode of acute urinary retention.
- Chronic painless urinary retention phenotype.
- Active urinary tract infection or sepsis.
- Gross hematuria with clot retention.
- Suspected or known urethral stricture.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TamsulosinTamsulosin 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. | Drug | Tamsulosin Plus Placebo, Tamsulosin Plus Tadalafil |
| TadalafilTadalafil 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. | Drug | Tamsulosin Plus Tadalafil |
| Tadalafil PlaceboA 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. | Drug | Tamsulosin Plus Placebo |
Primary outcome
Overall Catheter-Free Success by Day 14
Time frame: 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.
4 secondary outcomes
Successful Day-7 Trial Without Catheter
Time frame: Day 7
Successful Rescue Day-14 Trial Without Catheter Among Day-7 Failures
Time frame: Day 14
Recurrent Acute Urinary Retention Within 30 Days
Time frame: 30 days
Need for Benign Prostatic Hyperplasia-Related Surgery Within 3 Months
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: 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.
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Urinary Retention
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tamsulosin and Tadalafil in people with Acute Urinary Retention and Benign Prostatic Hyperplasia, run by Beni-Suef University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hany F Badawy, MD (+201149525028, HANYFATHY86@GMAIL.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Catheter-Free Success by Day 14 (time frame: Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.