PUL vs TURP in BPH Patients With Urinary Retention (PULTUR)

Queen Mary Hospital

Status: Enrolling

Conditions: BPH With Urinary Obstruction

Treatments: Device: Prostatic Urethral Lift; Procedure: TURP

Study type: Interventional

Funder types: Other

Identifiers

NCT06037356

QMH PULTUR Study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Male

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Prostatic Urethral Lift

Experimental group

Description:

Prostatic urethral lift implants will be placed in patients under local anesthesia or monitored anesthetic care. The number of implants used will depend on intra-operative findings, ranging from 2 to 8 implants per patient.

Treatment:

Device: Prostatic Urethral Lift

TURP

Active Comparator group

Description:

Transurethral resection of prostate (TURP) will be performed under spinal or general anesthesia as per usual care.

Treatment:

Procedure: TURP