[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658161":3},{"organization":4,"outcomesModule":7,"designInfo":45,"detailedDescription":56,"studyPopulation":44,"armGroups":57,"interventions":70,"overallOfficials":80,"centralContacts":85,"locations":44,"responsibleParty":94,"collaborators":44,"id":96,"slug":97,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":98,"sex":104,"minAge":105,"maxAge":44,"enrollmentInfo":106,"targetDuration":44,"studyType":109,"phases":110,"briefSummary":112,"conditions":113,"keywords":115,"overallStatus":123,"whyStopped":44,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":44},{"fullName":5,"class":6},"Shanghai East Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":44},[9,13],{"measure":10,"description":11,"timeFrame":12},"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\u002Fdistress; (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 \\\u003C +5.0%, in both the ITT and per-protocol populations.","Day 0 (catheter removal) through Day 30",{"measure":14,"description":15,"timeFrame":16},"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\u002Fsyncope 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).","Day 0 through Day 30",[18,22,26,29,32,36,40],{"measure":19,"description":20,"timeFrame":21},"Change in International Prostate Symptom Score (IPSS)","Absolute change and total score, compared between arms","Baseline (preoperative) to Day 30",{"measure":23,"description":24,"timeFrame":25},"Change in maximal urinary flow rate (Qmax)","Uroflowmetry, compared between arms.","Baseline to Day 30",{"measure":27,"description":28,"timeFrame":25},"Rate of unscheduled healthcare utilisation","Emergency department or unscheduled clinic visits for any urological cause",{"measure":30,"description":31,"timeFrame":16},"Incidence of severe macroscopic haematuria \u002F clot retention","Haemorrhagic events requiring bladder washout, manual clot evacuation, re-initiation of continuous bladder irrigation, or blood transfusion.",{"measure":33,"description":34,"timeFrame":35},"Medication adherence","Proportion of participants consuming \\>=80% and \\\u003C=120% of dispensed capsules (mandatory pill count)","Day 30",{"measure":37,"description":38,"timeFrame":39},"Health-related quality of life (EQ-5D-5L)","Utility scores mapped to the Chinese value set","Baseline and Day 30",{"measure":41,"description":42,"timeFrame":43},"Incremental cost-effectiveness ratio (ICER)","Cost per QALY gained for deprescribing vs routine continuation, from healthcare-system and societal perspectives.","Day 0 through Day 30 (extrapolated to 1 year by decision-analytic modelling)",null,{"allocation":46,"interventionModel":47,"interventionModelDescription":44,"primaryPurpose":48,"observationalModel":44,"timePerspective":44,"maskingInfo":49},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":50,"maskingDescription":44,"whoMasked":51},"QUADRUPLE",[52,53,54,55],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","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.\n\nAt 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.\n\nThe 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).\n\nSecondary endpoints include functional recovery (IPSS, Qmax), unscheduled healthcare utilisation, severe haematuria\u002Fclot retention, medication adherence, and a prospective health-economic evaluation (EQ-5D-5L, ICER).\n\nA 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.",[58,64],{"label":59,"type":60,"description":61,"interventionNames":62},"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).",[63],"Drug: Placebo",{"label":65,"type":66,"description":67,"interventionNames":68},"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.",[69],"Drug: Tamsulosin hydrochloride 0.2 mg",[71,76],{"type":72,"name":73,"description":74,"armGroupLabels":75,"otherNames":44},"DRUG","Tamsulosin hydrochloride 0.2 mg","As per Arm B",[65],{"type":72,"name":77,"description":78,"armGroupLabels":79,"otherNames":44},"Placebo","Matching placebo capsule, visually and organoleptically indistinguishable from the active capsules; identical packaging and labelling with a unique medication ID number.",[59],[81],{"name":82,"affiliation":83,"role":84},"haifeng wang","Changhai Hospital","STUDY_CHAIR",[86,91],{"name":87,"role":88,"phone":89,"phoneExt":44,"email":90},"biming He","CONTACT","15502139410","190589109@qq.com",{"name":82,"role":88,"phone":92,"phoneExt":44,"email":93},"86-13681750891","kuohaiandrew2000@vip.sina.com",{"type":95,"investigatorFullName":44,"investigatorTitle":44,"investigatorAffiliation":44,"oldNameTitle":44,"oldOrganization":44},"SPONSOR","100658161","phase-4-ceasing-alpha-blockers-early-after-resection-of-the-prostate-the-clear-trial-100658161",false,"NCT07846579","Ceasing Alpha-blockers Early After Resection of the Prostate (The CLEAR Trial)","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","CLEAR","Inclusion Criteria:\n\n1. Adult males aged \\>=50 years;\n2. Documented diagnosis of benign prostatic hyperplasia\u002Fbenign prostatic obstruction (BPH\u002FBPO) refractory to medical therapy, or with surgical indications (e.g., recurrent urinary retention, repeated gross haematuria, bladder calculi);\n3. Successful completion of an anatomical de-obstruction surgery (e.g., monopolar\u002Fbipolar TURP, HoLEP, ThuLEP) ;\n4. Continuous daily use of an oral alpha-1-adrenoceptor antagonist for at least 4 weeks immediately prior to surgery;\n5. Successful initial trial without catheter (TWOC) on postoperative day 2;\n6. Written informed consent and ability to comply with ePRO monitoring.\n\nExclusion Criteria:\n\n1. Resection\u002Fenucleation 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);\n2. Diagnosed neurogenic bladder (Parkinson's disease, multiple sclerosis, severe spinal cord injury, advanced diabetic cystopathy);\n3. Urodynamically proven detrusor underactivity\u002Fhypocontractile bladder prior to surgery;\n4. Clinically significant urethral stricture or bladder neck contracture requiring separate reconstruction;\n5. Documented history of recurrent unexplained syncope or severe symptomatic orthostatic hypotension prior to surgery;\n6. Inability to ambulate independently or perform the Active Stand Test;\n7. Requirement for continuous postoperative use of anticholinergics or beta-3 agonists;\n8. Continuation of 5-alpha-reductase inhibitors postoperatively against protocol.","MALE","50 Years",{"count":107,"type":108},400,"ESTIMATED","INTERVENTIONAL",[111],"PHASE4","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.\n\nIn 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).",[114],"Benign Prostatic Hyperplasia",[116,117,118,119,120,121,122],"deprescribing","tamsulosin","alpha-1 adrenoceptor antagonist","benign prostatic hyperplasia","postoperative urinary retention","orthostatic hypotension","falls","NOT_YET_RECRUITING","2026-09-23",{"date":126,"type":127},"2026-09-29","ACTUAL",{"date":129,"type":108},"2026-12-01",{"date":131,"type":108},"2029-02-01",{"name":5,"class":6}]