PUL vs TURP in BPH Patients With Urinary Retention

Queen Mary Hospital, Hong Kong100 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

BPH With Urinary Obstruction

Interventions

Prostatic Urethral LiftDEVICE

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

TURPPROCEDURE

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

Eligibility

Sex: MALEMin age: 40 Years

Medical Language ↔ Plain English

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

Locations (1)

Queen Mary Hospital

Hong Kong, China

RECRUITING

Outcomes

Primary Outcomes

Catheter-free rates after prostatic urethral lift versus TURP in BPH patients with urinary retention

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

Time frame: 1 year after intervention

Secondary Outcomes

Compare complication rate of prostatic urethral lift versus TURP in BPH patients with urinary retention

To determine the percentage and severity of complications after each intervention (according to the Clavien-Dindo classification)

Time frame: 5 years

Cost effectiveness of prostatic urethral lift versus TURP in achieving catheter-free rates in BPH patients with urinary retention

To determine the cost required to achieve catheter free patients for each intervention (including hospitalization, anesthetic costs, equipment, consumables, etc)

Time frame: 1 year

Compare patient satisfaction by PGI-I questionnaire after prostatic urethral lift versus TURP

Using the Patient global impression of improvement (PGI-I) questionnaire to determine patient satisfaction after each intervention. * minimum score is 1, maximum score is 7 * higher score means worse outcome

Time frame: 1 year

Compare patient reported symptom measures by IPSS questionnaire after prostatic urethral lift versus TURP

Using International prostate symptom score (IPSS) questionnaire to determine patient reported symptom measure after each intervention * minimal score: 0, maximum score is 35 * higher score means worse outcome

Time frame: 1 year

Compare patient reported symptom measures by ISI questionnaire after prostatic urethral lift versus TURP

Central Contacts

Brian SH Ho, MBBS

CONTACT

(852)2255-3023 hobrian@hku.hk

Stacia Chun, BSc(Hons)

CONTACT

(852)2255-4852 stac@hku.hk

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.