Actively Recruiting

Phase Not Applicable
Age: 40Years +
MALE
ID06037356

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

Led by Queen Mary Hospital, Hong Kong · Updated on 2025-07-24

100

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are conducting a prospective, randomized controlled trial to compare two treatments for benign prostatic hyperplasia (BPH) in male patients with urinary retention. The study aims to evaluate the catheter-free rates after treatment with prostatic urethral lift (PUL) versus transurethral resection of the prostate (TURP). Secondary goals include comparing complications, cost effectiveness, patient satisfaction, symptom scores, quality of life, and bladder function over time. Participants will be randomly assigned to one of two groups: the prostatic urethral lift group, where permanent implants made of special materials will be placed under local anesthesia or monitored anesthetic care; or the TURP group, where tissue is removed using surgical resection under spinal or general anesthesia. The number of implants during PUL varies based on findings during the procedure. Follow-up visits are scheduled at multiple time points up to 5 years after surgery. During the study, participants will undergo assessments including questionnaires, uroflowmetry tests, and occasional urodynamic studies. These evaluations will occur before treatment and at 1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years post-treatment. Researchers will monitor catheter-free rates, complications, patient-reported symptoms and satisfaction, quality of life, and bladder function to understand the long-term effects of both treatments.

CONDITIONS

Brief Title

PUL vs TURP in BPH Patients With Urinary Retention

Who Can Participate

Age: 40Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male patients
  • Age over 40 years old
  • Urinary retention who failed trial without catheter
Not Eligible

You will not qualify if you...

  • Inability to provide consent or no guardians or relatives to help provide consent
  • Active urinary tract infection
  • Previous surgical treatment for benign prostatic hyperplasia such as TURP or prostatic urethral lift
  • Presence of bladder stones
  • Urethral strictures or bladder neck contractures
  • Prostate size greater than 100 mL
  • Solely obstructing median lobe
  • Urinary retention not caused by obstruction (bladder outflow obstruction index less than 20)
  • Poor detrusor contractility (maximum detrusor pressure less than 20 cmH2O during voiding)
  • Use of anticoagulant or antiplatelet agents that cannot be stopped

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - Up to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit

Implementation

Duration - Day of procedure

Participants undergo either the prostatic urethral lift procedure under local anesthesia or monitored anesthetic care, or the TURP procedure under spinal or general anesthesia.

1 procedure visit

Post-operative Follow-up

Duration - Up to 5 years post-procedure

Participants have regular follow-up visits where assessments including questionnaires, uroflowmetry, and occasional urodynamic studies are conducted.

Follow-up visits at 1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years post-operatively

Trial Site Locations

Total: 1 location

1

Queen Mary Hospital

Hong Kong, China

Actively Recruiting

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Research Team

B

Brian SH Ho, MBBS

S

Stacia Chun, BSc(Hons)

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Treatment for benign prostatic hyperplasia among community dwelling men: the Olmsted County study of urinary symptoms and health status.

S J Jacobsen, D J Jacobson, C J Girman...

https://pubmed.ncbi.nlm.nih.gov/10492184

Transurethral prostatectomy: immediate and postoperative complications. a cooperative study of 13 participating institutions evaluating 3,885 patients. 1989.

W K Mebust, H L Holtgrewe, A T K Cockett...

https://pubmed.ncbi.nlm.nih.gov/11908420

Safety and feasibility of the prostatic urethral lift: a novel, minimally invasive treatment for lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH).

Henry H Woo, Peter T Chin, Thomas A McNicholas...

https://pubmed.ncbi.nlm.nih.gov/21554526

Real-World Evidence of Prostatic Urethral Lift Confirms Pivotal Clinical Study Results: 2-Year Outcomes of a Retrospective Multicenter Study.

Gregg Eure, Steven Gange, Peter Walter...

https://pubmed.ncbi.nlm.nih.gov/31115257

Treatment of LUTS secondary to BPH while preserving sexual function: randomized controlled study of prostatic urethral lift.

Kevin T McVary, Steven N Gange, Neal D Shore...

https://pubmed.ncbi.nlm.nih.gov/24119101