PUL vs TURP in BPH Patients With Urinary Retention

Last updated: July 21, 2025
Sponsor: Queen Mary Hospital, Hong Kong
Overall Status: Active - Recruiting

Phase

N/A

Condition

Enuresis

Urinary Incontinence

Genitourinary Prolapse

Treatment

TURP

Prostatic Urethral Lift

Clinical Study ID

NCT06037356
QMH PULTUR Study
  • Ages > 40
  • Male

Study 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 with urinary retention. The primary objective of this study is to compare the catheter-free rates of PUL vs TURP. Secondary objectives include comparison of complications rates, cost effectiveness, patient satisfactory, symptom scores, quality of life measures and urodynamic parameters.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male patients

  • age >40 years old

  • urinary retention who failed trial without catheter

Exclusion

Exclusion Criteria:

  • Inability to provide consent OR no guardians or relatives to help provide consent onpatient's behalf

  • Active urinary tract infection

  • Previous surgical treatment for benign prostatic hyperplasia (i.e., TURP, prostaticurethral 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 voidingphase)

  • Anticoagulant or antiplatelet agents that cannot be stopped

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: TURP
Phase:
Study Start date:
January 01, 2025
Estimated Completion Date:
May 30, 2035

Study 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 the potential risks, he will be screened for eligibility within a 4 week period. Assessment of eligibility will include questionnaires, blood tests, urine tests, uroflowmetry, flexible cystoscopy, transrectal ultrasound, and urodynamic study. Suitable subjects will then be randomized in a 1:1 ratio to the prostatic urethral lift (intervention group) and TURP (control group). Patients in the prostatic urethral lift will have the procedure performed under local anesthesia or monitored anesthetic care while TURP patients will be performed under spinal or general anesthesia. The subjects will have regular follow up 1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years post-operatively. Follow up assessments will include questionnaires, uroflowmetry, and occasional urodynamic study.

Connect with a study center

  • Queen Mary Hospital

    Hong Kong,
    China

    Active - Recruiting

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