Clinical trial NCT06037356: PUL vs TURP in BPH Patients With Urinary Retention
Official title: Prostatic Urethral Lift Versus Transurethral Resection of Prostate in Benign Prostatic Hyperplasia Patients With Urinary Retention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: BPH With Urinary Obstruction
Keywords: BPH
Urinary retention
prostatic urethral lift
PUL
TURP
Lead sponsor: Queen Mary Hospital, Hong Kong
Sponsor class: OTHER
First posted: 2023-09-14
Enrollment: 100
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will be a prospective, non-inferiority randomized controlled trial with the aim of detecting a non-inferiority margin of 5%. Subjects will be randomized in a 1:1 ratio.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Catheter-free rates after prostatic urethral lift versus TURP in BPH patients with urinary retention
timeFrame: 1 year after intervention
Secondary outcomes:
measure: Compare complication rate of prostatic urethral lift versus TURP in BPH patients with urinary retention
timeFrame: 5 years
measure: Cost effectiveness of prostatic urethral lift versus TURP in achieving catheter-free rates in BPH patients with urinary retention
timeFrame: 1 year
measure: Compare patient satisfaction by PGI-I questionnaire after prostatic urethral lift versus TURP
timeFrame: 1 year
measure: Compare patient reported symptom measures by IPSS questionnaire after prostatic urethral lift versus TURP
timeFrame: 1 year
measure: Compare patient reported symptom measures by ISI questionnaire after prostatic urethral lift versus TURP
timeFrame: 1 year
measure: Compare patient reported symptom measures by IIEF-5 questionnaire after prostatic urethral lift versus TURP
timeFrame: 1 year
measure: Compare patient reported symptom measures by MSHQ-EjD short form questionnaire after prostatic urethral lift versus TURP
timeFrame: 1 year
measure: Compare patient reported quality of life by SF-12 questionnaire after prostatic urethral lift versus TURP
timeFrame: 1 year
measure: Compare patient reported quality of life by derived SF-6D utility score after prostatic urethral lift versus TURP
timeFrame: 1 year
measure: Compare patient reported recovery by VAS after prostatic urethral lift versus TURP
timeFrame: 1 year
measure: Compare improvement bladder contractility index after prostatic urethral lift versus TURP
timeFrame: 5 year
measure: Compare improvement of Bladder outflow obstruction index after prostatic urethral lift versus TURP
timeFrame: 5 year
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Queen Mary Hospital
Study officials:
affiliation: Queen Mary Hospital, Hong Kong
name: Brian SH Ho, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Jacobsen SJ, Jacobson DJ, Girman CJ, Roberts RO, Rhodes T, Guess HA, Lieber MM. Treatment for benign prostatic hyperplasia among community dwelling men: the Olmsted County study of urinary symptoms and health status. J Urol. 1999 Oct;162(4):1301-6.
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citation: Mebust WK, Holtgrewe HL, Cockett AT, Peters PC. Transurethral prostatectomy: immediate and postoperative complications. a cooperative study of 13 participating institutions evaluating 3,885 patients. 1989. J Urol. 2002 Feb;167(2 Pt 2):999-1003; discussion 1004. No abstract available.
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citation: Eure G, Gange S, Walter P, Khan A, Chabert C, Mueller T, Cozzi P, Patel M, Freedman S, Chin P, Ochs S, Hirsh A, Trotter M, Grier D. Real-World Evidence of Prostatic Urethral Lift Confirms Pivotal Clinical Study Results: 2-Year Outcomes of a Retrospective Multicenter Study. J Endourol. 2019 Jul;33(7):576-584. doi: 10.1089/end.2019.0167. Epub 2019 Jun 25.
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