RecruitingNot ApplicableNCT06037356

PUL vs TURP in BPH Patients With Urinary Retention

Prostatic Urethral Lift Versus Transurethral Resection of Prostate in Benign Prostatic Hyperplasia Patients With Urinary Retention


Sponsor

Queen Mary Hospital, Hong Kong

Enrollment

100 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: MALEMin Age: 40 Years

Inclusion Criteria3

  • Male patients
  • age \>40 years old
  • urinary retention who failed trial without catheter

Exclusion Criteria10

  • 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

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Interventions

DEVICEProstatic Urethral Lift

Prostatic urethral lift uses permanent implants to retract the prostate lobes away from the prostate urethra to allow unobstructed passage of urine. These implants are made of Nitinol, non-absorbable monofilament suture material (Poly Ethylene Terephthalate), Stainless Steel

PROCEDURETURP

Using monopolar or bipolar loop diathermy via cystoscopy, excess prostate tissue is resected piecemeal to remove obstruction to the prostatic urethra due to BPH


Locations(1)

Queen Mary Hospital

Hong Kong, China

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NCT06037356


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