Prostatic Urethral Lift Versus Transurethral Resection of Prostate in Benign Prostatic Hyperplasia Patients With Urinary Retention
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Catheter-free rates after prostatic urethral lift versus TURP in BPH patients with urinary retention
Study Overview
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 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.
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male patients
- •age >40 years old
- •urinary retention who failed trial without catheter
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Catheter-free rates after prostatic urethral lift versus TURP in BPH patients with urinary retention
Time Frame: 1 year after intervention
To determine how many patients will be catheter-free (defined as by the ability to void with a post-void residual urine \<300mL) after intervention and remain catheter-free at 1 month, 3 months, and 1 year after intervention
Secondary Outcomes
- Cost effectiveness of prostatic urethral lift versus TURP in achieving catheter-free rates in BPH patients with urinary retention(1 year)
- Compare patient reported symptom measures by ISI questionnaire after prostatic urethral lift versus TURP(1 year)
- Compare patient reported symptom measures by MSHQ-EjD short form questionnaire after prostatic urethral lift versus TURP(1 year)
- Compare improvement bladder contractility index after prostatic urethral lift versus TURP(5 year)
- Compare patient satisfaction by PGI-I questionnaire after prostatic urethral lift versus TURP(1 year)
- Compare patient reported quality of life by derived SF-6D utility score after prostatic urethral lift versus TURP(1 year)
- Compare improvement of Bladder outflow obstruction index after prostatic urethral lift versus TURP(5 year)
- Compare complication rate of prostatic urethral lift versus TURP in BPH patients with urinary retention(5 years)
- Compare patient reported symptom measures by IPSS questionnaire after prostatic urethral lift versus TURP(1 year)
- Compare patient reported symptom measures by IIEF-5 questionnaire after prostatic urethral lift versus TURP(1 year)
- Compare patient reported quality of life by SF-12 questionnaire after prostatic urethral lift versus TURP(1 year)
- Compare patient reported recovery by VAS after prostatic urethral lift versus TURP(1 year)
Investigators
Brian Ho
Associate Consultant
Queen Mary Hospital, Hong Kong