A Phase 4 interventional study of Tamsulosin hydrochloride 0.2 mg and Placebo in Benign Prostatic Hyperplasia, sponsored by Shanghai East Hospital. Not yet recruiting. Open to male participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Shanghai East Hospital · Phase 4, Interventional, and Treatment
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).
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.
Exclusion Criteria:
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).
Drug: Placebo
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.
Drug: Tamsulosin hydrochloride 0.2 mg
As per Arm B
Matching placebo capsule, visually and organoleptically indistinguishable from the active capsules; identical packaging and labelling with a unique medication ID number.
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.
Time frame: 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).
Time frame: Day 0 through Day 30
Change in International Prostate Symptom Score (IPSS)
Absolute change and total score, compared between arms
Time frame: Baseline (preoperative) to Day 30
Change in maximal urinary flow rate (Qmax)
Uroflowmetry, compared between arms.
Time frame: Baseline to Day 30
Rate of unscheduled healthcare utilisation
Emergency department or unscheduled clinic visits for any urological cause
Time frame: 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.
Time frame: Day 0 through Day 30
Medication adherence
Proportion of participants consuming \>=80% and \<=120% of dispensed capsules (mandatory pill count)
Time frame: Day 30
Health-related quality of life (EQ-5D-5L)
Utility scores mapped to the Chinese value set
Time frame: Baseline and Day 30
Incremental cost-effectiveness ratio (ICER)
Cost per QALY gained for deprescribing vs routine continuation, from healthcare-system and societal perspectives.
Time frame: Day 0 through Day 30 (extrapolated to 1 year by decision-analytic modelling)
No study locations are listed for this record.
Plan to share: 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.
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Shanghai East Hospital