Ceasing Alpha-blockers Early After Resection of the Prostate (The CLEAR Trial)

NCT07846579 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: 2026303
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief 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 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).

Conditions

Benign Prostatic Hyperplasia

Keywords

deprescribing; tamsulosin; alpha-1 adrenoceptor antagonist; benign prostatic hyperplasia; postoperative urinary retention; orthostatic hypotension; falls

Outcome Measures

Primary Outcomes (2)

• 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.

  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).

  Day 0 through Day 30

Secondary Outcomes (7)

• Change in International Prostate Symptom Score (IPSS)

  Baseline (preoperative) to Day 30

• Change in maximal urinary flow rate (Qmax)

  Baseline to Day 30

• Rate of unscheduled healthcare utilisation

  Baseline to Day 30

• Incidence of severe macroscopic haematuria / clot retention

  Day 0 through Day 30

• Medication adherence

  Day 30

Study Arms (2)

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).

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.

Drug: Tamsulosin hydrochloride 0.2 mg

Interventions

Tamsulosin hydrochloride 0.2 mg DRUG

As per Arm B

Standard of Care (Tamsulosin)

Placebo DRUG

Matching placebo capsule, visually and organoleptically indistinguishable from the active capsules; identical packaging and labelling with a unique medication ID number.

Deprescribing (Placebo)

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai East Hospital: lead

MeSH Terms

Conditions

Prostatic Hyperplasia; Hypotension, Orthostatic

Interventions

Tamsulosin

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Hypotension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Officials

• haifeng wang

  Changhai Hospital

  STUDY CHAIR

Central Study Contacts

biming He

CONTACT

15502139410; 190589109@qq.com

haifeng wang

CONTACT

86-13681750891; kuohaiandrew2000@vip.sina.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2026
• First Posted: September 29, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): February 1, 2029
• Last Updated: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning after publication of the primary trial results.
• Access Criteria: Proposals will be reviewed by the Trial Steering Committee; access requires approval and a data-access agreement.