Status:
RECRUITING
PUL vs TURP in BPH Patients With Urinary Retention
Lead Sponsor:
Queen Mary Hospital, Hong Kong
Conditions:
BPH With Urinary Obstruction
Eligibility:
MALE
40+ years
Phase:
NA
Brief Summary
The study will be a prospective, randomized controlled trial comparing prostatic urethral lift (PUL) versus transurethral resection of prostate (TURP) in benign prostate hyperplasia (BPH) patients wit...
Detailed Description
The study will be a prospective, non-inferiority randomized controlled trial with the aim of detecting a non-inferiority margin of 5%. After the potential subject has been informed of the study and t...
Eligibility Criteria
Inclusion
- Male patients
- age \>40 years old
- urinary retention who failed trial without catheter
Exclusion
- Inability to provide consent OR no guardians or relatives to help provide consent on patient's behalf
- Active urinary tract infection
- Previous surgical treatment for benign prostatic hyperplasia (i.e., TURP, prostatic urethral lift, etc.)
- Bladder stones
- Urethral strictures or bladder neck contractures
- Prostate size \>100mL
- Solely obstructing median lobe
- Urinary retention not due to obstruction (i.e., Bladder outflow obstruction index \<20 on urodynamic studies)
- Poor detrusor contractility (maximum detrusor pressure \<20cmH2O during voiding phase)
- Anticoagulant or antiplatelet agents that cannot be stopped
Key Trial Info
Start Date :
January 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 30 2035
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06037356
Start Date
January 1 2025
End Date
May 30 2035
Last Update
July 24 2025
Active Locations (1)
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1
Queen Mary Hospital
Hong Kong, China