Health TrialsbyHealthPanel

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

ConditionBenign Prostatic Hyperplasia
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexMale
Age50+
SponsorShanghai East Hospital

About this 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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tamsulosin hydrochloride 0.2 mg

    Drug

    As per Arm B

  • Placebo

    Drug

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

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Deprescribing (Placebo)Experimental treatment 1 intervention
Group B: Standard of Care (Tamsulosin)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

1

Change in International Prostate Symptom Score (IPSS)

Absolute change and total score, compared between arms

Time frame
Baseline (preoperative) to Day 30
2

Change in maximal urinary flow rate (Qmax)

Uroflowmetry, compared between arms.

Time frame
Baseline to Day 30
3

Rate of unscheduled healthcare utilisation

Emergency department or unscheduled clinic visits for any urological cause

Time frame
Baseline to Day 30
4

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai East Hospital

Lead sponsor

Source ClinicalTrials.gov

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