Benign Prostatic HyperplasiaPhase 4CLEARNCT07846579
Ceasing Alpha-blockers Early After Resection of the Prostate (The CLEAR Trial)
A Phase 4 study testing Tamsulosin hydrochloride 0.2 mg in people with Benign Prostatic Hyperplasia, run by Shanghai East Hospital.
Trial summary
After surgery for benign prostatic hyperplasia (BPH) that physically removes the prostatic transition zone (such as TURP or laser enucleation), many men are routinely sent home with a 2- to 4-week prescription of an alpha-blocker (tamsulosin) to prevent urinary retention, even though the tissue targeted by the drug… Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Tamsulosin hydrochloride 0.2 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 1 Feb 2029
- 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
- Adult males aged >=50 years;
- Documented diagnosis of benign prostatic hyperplasia/benign prostatic obstruction (BPH/BPO) refractory to medical therapy, or with surgical indications (e.g., recurrent urinary retention, repeated gross haematuria, bladder calculi);
- Successful completion of an anatomical de-obstruction surgery (e.g., monopolar/bipolar TURP, HoLEP, ThuLEP) ;
- Continuous daily use of an oral alpha-1-adrenoceptor antagonist for at least 4 weeks immediately prior to surgery;
- Successful initial trial without catheter (TWOC) on postoperative day 2;
- Written informed consent and ability to comply with ePRO monitoring.
Who cannot join
- Resection/enucleation deemed "incomplete" or "suboptimal" by the primary surgeon, or severe intraoperative complications (e.g., capsular perforation requiring prolonged traction, significant rectal injury, massive haemorrhage necessitating continuous irrigation beyond 48 hours);
- Diagnosed neurogenic bladder (Parkinson's disease, multiple sclerosis, severe spinal cord injury, advanced diabetic cystopathy);
- Urodynamically proven detrusor underactivity/hypocontractile bladder prior to surgery;
- Clinically significant urethral stricture or bladder neck contracture requiring separate reconstruction;
- Documented history of recurrent unexplained syncope or severe symptomatic orthostatic hypotension prior to surgery;
- Inability to ambulate independently or perform the Active Stand Test;
- Requirement for continuous postoperative use of anticholinergics or beta-3 agonists;
- Continuation of 5-alpha-reductase inhibitors postoperatively against protocol.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Ceasing aLpha-blockers Early After Resection of the Prostate (The CLEAR Trial): A Multicenter, Double-blind, Placebo-controlled, Non-inferiority and Nested Superiority Randomized Clinical Trial
After surgery for benign prostatic hyperplasia (BPH) that physically removes the prostatic transition zone (such as TURP or laser enucleation), many men are routinely sent home with a 2- to 4-week prescription of an alpha-blocker (tamsulosin) to prevent urinary retention, even though the tissue targeted by the drug has been removed. Alpha-blockers can cause blood-pressure drops upon standing, fainting, and falls in older men.
In this study, men who have successfully undergone BPH surgery and passed an initial voiding trial are randomly assigned to take either tamsulosin or an identical-looking placebo capsule once daily for 30 days. The study tests whether stopping the drug immediately does not increase the risk of needing a catheter again (non-inferiority), and whether stopping it reduces dizziness, fainting, and falls (superiority).
Read the detailed description
The CLEAR trial is an investigator-initiated, multicentre, double-blind, placebo-controlled, randomised clinical trial with a hierarchical co-primary endpoint design and a Bayesian adaptive group-sequential plan. Eligible participants are men aged 50 years or older with BPH refractory to medical therapy who have used an oral alpha-1-blocker daily for at least 4 weeks before surgery, have successfully completed anatomical de-obstruction surgery (resection or enucleation), and have passed an initial trial without catheter on postoperative day 2.
At the time of successful catheter removal (Day 0), participants are randomised 1:1 via a central interactive web-response system, using covariate-adaptive minimisation stratified by clinical centre, surgical modality (resection vs enucleation), and concurrent antihypertensive use, to receive tamsulosin hydrochloride 0.2 mg or an organoleptically identical placebo once daily for 30 days.
The trial first tests the non-inferiority of placebo for the rate of unplanned re-catheterisation due to acute postoperative urinary retention within 30 days (objective criteria: inability to void, post-void residual >=300 mL on bladder scan, refractory to 2-hour conservative measures; non-inferiority margin 5.0%). Conditional on non-inferiority being established, it then tests the superiority of placebo for the composite incidence of symptomatic orthostatic hypotension, presyncope, syncope, and falls within 30 days, captured by a standardised Active Stand Test and twice-weekly electronic patient-reported outcomes, and adjudicated by an independent, blinded Clinical Event Committee. Unblinded interim analyses are performed by the independent Data and Safety Monitoring Board when 200 and 300 participants have completed the Day 30 assessment, with early stopping guided by the Bayesian predictive probability of success (thresholds 0.95 for early success and 0.10 for futility).
Secondary endpoints include functional recovery (IPSS, Qmax), unscheduled healthcare utilisation, severe haematuria/clot retention, medication adherence, and a prospective health-economic evaluation (EQ-5D-5L, ICER).
A prespecified blinded sample-size re-estimation, based on the pooled (arm-agnostic) event rate at the first interim analysis, allows maximum enrolment to be increased from 400 up to 600 participants to preserve conditional power, without unblinding.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Tamsulosin hydrochloride 0.2 mg, Placebo
- Keywords
- deprescribing, tamsulosin, alpha-1 adrenoceptor antagonist, benign prostatic hyperplasia, postoperative urinary retention, orthostatic hypotension, falls
- Medical subject headings
- Prostatic Hyperplasia, Hypotension, Orthostatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tamsulosin hydrochloride 0.2 mgDrug
As per Arm B
PlaceboDrug
Matching placebo capsule, visually and organoleptically indistinguishable from the active capsules; identical packaging and labelling with a unique medication ID number.
| Study group | Role | What they receive |
|---|---|---|
| Deprescribing (Placebo) | Experimental | Organoleptically identical placebo capsule, one capsule orally once daily (after dinner or at bedtime) for 30 days, starting on the day of successful catheter removal (Day 0). Receives: Drug: Placebo |
| Standard of Care (Tamsulosin) | Active comparator | Tamsulosin hydrochloride 0.2 mg sustained-release capsule, one capsule orally once daily for 30 days, starting on the day of successful catheter removal (Day 0). 0.2 mg once daily is the approved standard dosage in China and several Asian populations. Receives: Drug: Tamsulosin hydrochloride 0.2 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of unplanned re-catheterisation due to acute postoperative urinary retention (POUR)
Proportion of participants requiring unplanned re-catheterisation meeting ALL objective criteria: (i) complete inability to void spontaneously with suprapubic pain/distress; (ii) post-void residual >=300 mL on bladder ultrasound; (iii) failure of conservative measures over a 2-hour observation period. Re-catheterisation for clot retention is not counted. Analysed as the absolute risk difference (placebo minus tamsulosin); non-inferiority declared if the upper bound of the two-sided 95% CI is < +5.0%, in both the ITT and per-protocol populations.
Measured: Day 0 (catheter removal) through Day 30
Composite incidence of symptomatic orthostatic hypotension, presyncope, syncope, and falls
Composite of: (i) orthostatic hypotension on the standardised Active Stand Test (systolic drop >=20 mmHg or diastolic drop >=10 mmHg within 3 minutes of standing, or reproduction of cerebral hypoperfusion symptoms); (ii) self-reported presyncope/syncope captured by twice-weekly ePRO; (iii) falls (WHO definition). All clinical events adjudicated by an independent, blinded Clinical Event Committee. Tested for superiority only if non-inferiority of the efficacy endpoint is established (hierarchical gatekeeping).
Measured: Day 0 through Day 30
Secondary outcomes (7)
Change in International Prostate Symptom Score (IPSS)
Absolute change and total score, compared between arms
Measured: Baseline (preoperative) to Day 30
Change in maximal urinary flow rate (Qmax)
Uroflowmetry, compared between arms.
Measured: Baseline to Day 30
Rate of unscheduled healthcare utilisation
Emergency department or unscheduled clinic visits for any urological cause
Measured: Baseline to Day 30
Incidence of severe macroscopic haematuria / clot retention
Haemorrhagic events requiring bladder washout, manual clot evacuation, re-initiation of continuous bladder irrigation, or blood transfusion.
Measured: Day 0 through Day 30
Medication adherence
Proportion of participants consuming >=80% and <=120% of dispensed capsules (mandatory pill count)
Measured: Day 30
Health-related quality of life (EQ-5D-5L)
Utility scores mapped to the Chinese value set
Measured: Baseline and Day 30
Incremental cost-effectiveness ratio (ICER)
Cost per QALY gained for deprescribing vs routine continuation, from healthcare-system and societal perspectives.
Measured: Day 0 through Day 30 (extrapolated to 1 year by decision-analytic modelling)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai East Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- haifeng wang, Study chair, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07846579
- Sponsor's protocol ID
- 2026303
- Acronym
- CLEAR
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data and the signed statistical analysis plan will be available upon reasonable request to qualified academic researchers whose proposed analyses have been approved by an independent review committee.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ceasing aLpha-blockers Early After Resection of the Prostate (The CLEAR Trial): A Multicenter, Double-blind, Placebo-controlled, Non-inferiority and Nested Superiority Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07846579
- Acronym / sponsor ID
- CLEAR / 2026303
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- deprescribing, tamsulosin, alpha-1 adrenoceptor antagonist, benign prostatic hyperplasia, postoperative urinary retention, orthostatic hypotension, falls
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Shanghai East HospitalUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Feb 2029 (estimated)
- First posted
- 29 Sep 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.
After surgery for benign prostatic hyperplasia (BPH) that physically removes the prostatic transition zone (such as TURP or laser enucleation), many men are routinely sent home with a 2- to 4-week prescription of an alpha-blocker (tamsulosin) to prevent urinary retention, even though the tissue targeted by the drug has been removed. Alpha-blockers can cause blood-pressure drops upon standing, fainting, and falls in older men.
In this study, men who have successfully undergone BPH surgery and passed an initial voiding trial are randomly assigned to take either tamsulosin or an identical-looking placebo capsule once daily for 30 days. The study tests whether stopping the drug immediately does not increase the risk of needing a catheter again (non-inferiority), and whether stopping it reduces dizziness, fainting, and falls (superiority).
Detailed description
The CLEAR trial is an investigator-initiated, multicentre, double-blind, placebo-controlled, randomised clinical trial with a hierarchical co-primary endpoint design and a Bayesian adaptive group-sequential plan. Eligible participants are men aged 50 years or older with BPH refractory to medical therapy who have used an oral alpha-1-blocker daily for at least 4 weeks before surgery, have successfully completed anatomical de-obstruction surgery (resection or enucleation), and have passed an initial trial without catheter on postoperative day 2.
At the time of successful catheter removal (Day 0), participants are randomised 1:1 via a central interactive web-response system, using covariate-adaptive minimisation stratified by clinical centre, surgical modality (resection vs enucleation), and concurrent antihypertensive use, to receive tamsulosin hydrochloride 0.2 mg or an organoleptically identical placebo once daily for 30 days.
The trial first tests the non-inferiority of placebo for the rate of unplanned re-catheterisation due to acute postoperative urinary retention within 30 days (objective criteria: inability to void, post-void residual >=300 mL on bladder scan, refractory to 2-hour conservative measures; non-inferiority margin 5.0%). Conditional on non-inferiority being established, it then tests the superiority of placebo for the composite incidence of symptomatic orthostatic hypotension, presyncope, syncope, and falls within 30 days, captured by a standardised Active Stand Test and twice-weekly electronic patient-reported outcomes, and adjudicated by an independent, blinded Clinical Event Committee. Unblinded interim analyses are performed by the independent Data and Safety Monitoring Board when 200 and 300 participants have completed the Day 30 assessment, with early stopping guided by the Bayesian predictive probability of success (thresholds 0.95 for early success and 0.10 for futility).
Secondary endpoints include functional recovery (IPSS, Qmax), unscheduled healthcare utilisation, severe haematuria/clot retention, medication adherence, and a prospective health-economic evaluation (EQ-5D-5L, ICER).
A prespecified blinded sample-size re-estimation, based on the pooled (arm-agnostic) event rate at the first interim analysis, allows maximum enrolment to be increased from 400 up to 600 participants to preserve conditional power, without unblinding.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deprescribing (Placebo) | Experimental | Drug: PlaceboOrganoleptically identical placebo capsule, one capsule orally once daily (after dinner or at bedtime) for 30 days, starting on the day of successful catheter removal (Day 0). |
| Standard of Care (Tamsulosin) | Active comparator | Drug: Tamsulosin hydrochloride 0.2 mgTamsulosin hydrochloride 0.2 mg sustained-release capsule, one capsule orally once daily for 30 days, starting on the day of successful catheter removal (Day 0). 0.2 mg once daily is the approved standard dosage in China and several Asian populations. |
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)
- Adult males aged >=50 years;
- Documented diagnosis of benign prostatic hyperplasia/benign prostatic obstruction (BPH/BPO) refractory to medical therapy, or with surgical indications (e.g., recurrent urinary retention, repeated gross haematuria, bladder calculi);
- Successful completion of an anatomical de-obstruction surgery (e.g., monopolar/bipolar TURP, HoLEP, ThuLEP) ;
- Continuous daily use of an oral alpha-1-adrenoceptor antagonist for at least 4 weeks immediately prior to surgery;
- Successful initial trial without catheter (TWOC) on postoperative day 2;
Key exclusion criteria (8 listed)
- Resection/enucleation deemed "incomplete" or "suboptimal" by the primary surgeon, or severe intraoperative complications (e.g., capsular perforation requiring prolonged traction, significant rectal injury, massive haemorrhage necessitating continuous irrigation beyond 48 hours);
- Diagnosed neurogenic bladder (Parkinson's disease, multiple sclerosis, severe spinal cord injury, advanced diabetic cystopathy);
- Urodynamically proven detrusor underactivity/hypocontractile bladder prior to surgery;
- Clinically significant urethral stricture or bladder neck contracture requiring separate reconstruction;
- Documented history of recurrent unexplained syncope or severe symptomatic orthostatic hypotension prior to surgery;
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 hydrochloride 0.2 mgAs per Arm B | Drug | Standard of Care (Tamsulosin) |
| PlaceboMatching placebo capsule, visually and organoleptically indistinguishable from the active capsules; identical packaging and labelling with a unique medication ID number. | Drug | Deprescribing (Placebo) |
Primary outcome
Rate of unplanned re-catheterisation due to acute postoperative urinary retention (POUR)
Time frame: Day 0 (catheter removal) through Day 30
Proportion of participants requiring unplanned re-catheterisation meeting ALL objective criteria: (i) complete inability to void spontaneously with suprapubic pain/distress; (ii) post-void residual >=300 mL on bladder ultrasound; (iii) failure of conservative measures over a 2-hour observation period. Re-catheterisation for clot retention is not counted. Analysed as the absolute risk difference (placebo minus tamsulosin); non-inferiority declared if the upper bound of the two-sided 95% CI is < +5.0%, in both the ITT and per-protocol populations.
Composite incidence of symptomatic orthostatic hypotension, presyncope, syncope, and falls
Time frame: Day 0 through Day 30
Composite of: (i) orthostatic hypotension on the standardised Active Stand Test (systolic drop >=20 mmHg or diastolic drop >=10 mmHg within 3 minutes of standing, or reproduction of cerebral hypoperfusion symptoms); (ii) self-reported presyncope/syncope captured by twice-weekly ePRO; (iii) falls (WHO definition). All clinical events adjudicated by an independent, blinded Clinical Event Committee. Tested for superiority only if non-inferiority of the efficacy endpoint is established (hierarchical gatekeeping).
7 secondary outcomes
Change in International Prostate Symptom Score (IPSS)
Time frame: Baseline (preoperative) to Day 30
Change in maximal urinary flow rate (Qmax)
Time frame: Baseline to Day 30
Rate of unscheduled healthcare utilisation
Time frame: Baseline to Day 30
Incidence of severe macroscopic haematuria / clot retention
Time frame: Day 0 through Day 30
Medication adherence
Time frame: Day 30
Health-related quality of life (EQ-5D-5L)
Time frame: Baseline and Day 30
Incremental cost-effectiveness ratio (ICER)
Time frame: Day 0 through Day 30 (extrapolated to 1 year by decision-analytic modelling)
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 29 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data and the signed statistical analysis plan will be available upon reasonable request to qualified academic researchers whose proposed analyses have been approved by an independent review committee.
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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.
haifeng wang study chair
Changhai Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tamsulosin hydrochloride 0.2 mg in people with Benign Prostatic Hyperplasia, run by Shanghai East Hospital.
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 8 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: opening soon, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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 biming He (15502139410, 190589109@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of unplanned re-catheterisation due to acute postoperative urinary retention (POUR) (time frame: Day 0 (catheter removal) through Day 30). The study lists 2 primary outcomes in all. 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 29 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.