Acute Urinary RetentionPhase 4NCT07650968
Tamsulosin Dose Escalation or Silodosin Switch Before Trial Without Catheter in BPH-Related Acute Urinary Retention
A Phase 4 study testing Tamsulosin 0.4 mg, Tamsulosin 0.8 mg and Silodosin 8 mg in people with Acute Urinary Retention and Benign Prostatic Hyperplasia, run by Beni-Suef University at 1 site in Egypt.
Trial summary
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. 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
- What is being tested?
- Tamsulosin 0.4 mg, Tamsulosin 0.8 mg and Silodosin 8 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 378 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Jun 2026to Jun 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 patients aged 50 years or older.
- Acute urinary retention requiring urethral catheterization.
- Presumed acute urinary retention secondary to benign prostatic enlargement or benign prostatic obstruction.
- Already receiving tamsulosin 0.4 mg once daily for at least 4 weeks before the acute urinary retention episode.
- Successful urethral catheterization at presentation.
- Initial catheterized urine volume ≤1000 mL, with a clinical presentation consistent with painful acute urinary retention.
- Prostate enlargement on ultrasound or clinical assessment consistent with benign prostatic hyperplasia or benign prostatic obstruction.
- Ability to provide written informed consent.
Who cannot join
- Known or suspected prostate cancer.
- Previous prostate surgery.
- Previous urethral stricture disease or urethral surgery.
- Neurogenic bladder or known neurological disease affecting voiding.
- Chronic urinary retention rather than acute painful retention.
- Acute urinary retention due to non-BPH causes, including clot retention, bladder stone obstruction, acute prostatitis, urethral trauma, or drug-induced retention.
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- Severe urinary tract infection, sepsis, or fever at presentation.
- Gross hematuria requiring irrigation.
- Failed urethral catheterization or need for suprapubic catheterization.
- Current use of silodosin, alfuzosin, doxazosin, terazosin, tadalafil, anticholinergics, beta-3 agonists, or other drugs that may significantly affect voiding.
- Severe renal impairment requiring urgent intervention.
- Symptomatic postural hypotension or recurrent syncope.
- Known hypersensitivity to silodosin.
- Severe hepatic impairment.
- Inability to comply with follow-up.
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
Hany F Badawy, MD
About this study
Official title: Tamsulosin 0.4 mg Continuation Versus Dose Escalation to 0.8 mg Versus Switch to Silodosin 8 mg for Trial Without Catheter After Acute Urinary Retention Due to Benign Prostatic Hyperplasia: A Randomized Controlled Trial
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.
Read the detailed description
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.
- Being tested
- Tamsulosin 0.4 mg, Tamsulosin 0.8 mg, Silodosin 8 mg
- Keywords
- Trial Without Catheter, Tamsulosin, Silodosin, Catheter-free status
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tamsulosin 0.4 mgDrug
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.
Tamsulosin 0.8 mgDrug
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 mgDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Tamsulosin 0.4 mg |
| 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. Receives: Drug: Tamsulosin 0.8 mg |
| 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. Receives: Drug: Silodosin 8 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 7, with assessment continuing for 24 hours after catheter removal
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start8 Jun 2026
- Primary completionMay 2027 (estimated)
- Study completionJun 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.
- 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 1:1:1 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 378 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
- NCT07650968
- Sponsor's protocol ID
- TAMS-TWOC-2026
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tamsulosin 0.4 mg Continuation Versus Dose Escalation to 0.8 mg Versus Switch to Silodosin 8 mg for Trial Without Catheter After Acute Urinary Retention Due to Benign Prostatic Hyperplasia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07650968
- Acronym / sponsor ID
- TAMS-TWOC-2026
- Keywords
- Trial Without Catheter, Tamsulosin, Silodosin, Catheter-free status
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 378 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 8 Jun 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 16 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Tamsulosin 0.4 mg Continuation | Active comparator | Drug: Tamsulosin 0.4 mgParticipants 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 | Drug: Tamsulosin 0.8 mgParticipants 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 | Drug: Silodosin 8 mgParticipants 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male patients aged 50 years or older.
- Acute urinary retention requiring urethral catheterization.
- Presumed acute urinary retention secondary to benign prostatic enlargement or benign prostatic obstruction.
- Already receiving tamsulosin 0.4 mg once daily for at least 4 weeks before the acute urinary retention episode.
- Successful urethral catheterization at presentation.
Key exclusion criteria (15 listed)
- Known or suspected prostate cancer.
- Previous prostate surgery.
- Previous urethral stricture disease or urethral surgery.
- Neurogenic bladder or known neurological disease affecting voiding.
- Chronic urinary retention rather than acute painful retention.
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 |
|---|---|---|
| Tamsulosin 0.4 mgParticipants 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. | Drug | Tamsulosin 0.4 mg Continuation |
| Tamsulosin 0.8 mgParticipants 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. | Drug | Tamsulosin 0.8 mg Dose Escalation |
| Silodosin 8 mgParticipants 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. | Drug | Switch to Silodosin 8 mg |
Primary outcome
Successful Trial Without Catheter at Day 7
Time frame: Day 7, with assessment continuing for 24 hours after catheter removal
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.
3 secondary outcomes
Catheter-Free Status at Day 14
Time frame: Day 14
Recurrent Acute Urinary Retention Within 30 Days
Time frame: Up to 30 days
Adverse Drug Events
Time frame: Up to 30 days
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 16 Jun 2026.
- Individual participant dataSharing planned: 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.
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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 0.4 mg, Tamsulosin 0.8 mg and Silodosin 8 mg 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 8 inclusion and 15 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 16 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. 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?
Successful Trial Without Catheter at Day 7 (time frame: Day 7, with assessment continuing for 24 hours after catheter removal). 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 16 Jun 2026.