PUL vs TURP in BPH Patients With Urinary Retention
- Conditions
- BPH With Urinary Obstruction
- Interventions
- Procedure: TURPDevice: Prostatic Urethral Lift
- Registration Number
- NCT06037356
- Lead Sponsor
- Queen Mary Hospital, Hong Kong
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 100
- Male patients
- age >40 years old
- urinary retention who failed trial without catheter
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TURP TURP Transurethral resection of prostate (TURP) will be performed under spinal or general anesthesia as per usual care. Prostatic Urethral Lift Prostatic Urethral Lift 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.
- Primary Outcome Measures
Name Time Method Catheter-free rates after prostatic urethral lift versus TURP in BPH patients with urinary retention 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 Outcome Measures
Name Time Method Cost effectiveness of prostatic urethral lift versus TURP in achieving catheter-free rates in BPH patients with urinary retention 1 year To determine the cost required to achieve catheter free patients for each intervention (including hospitalization, anesthetic costs, equipment, consumables, etc)
Compare patient reported symptom measures by ISI questionnaire after prostatic urethral lift versus TURP 1 year Using the Incontinence severity index (ISI) questionnaire to determine patient reported symptom measure after each intervention
* minimum score: 1, maximum score: 12
* higher score means worse outcomeCompare patient reported symptom measures by MSHQ-EjD short form questionnaire after prostatic urethral lift versus TURP 1 year Using the Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD) short form questionnaire to determine patient reported symptom measure after each intervention.
Compare improvement bladder contractility index after prostatic urethral lift versus TURP 5 year Pre- and post-intervention urodynamic will be performed to assess bladder contractility index as well as subsequent improvement and durability of above stated urodynamic parameter after each intervention
Compare patient satisfaction by PGI-I questionnaire after prostatic urethral lift versus TURP 1 year 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 outcomeCompare patient reported quality of life by derived SF-6D utility score after prostatic urethral lift versus TURP 1 year Using the derived Short Form 6 Dimension (SF-6D) utility score questionnaire to determine patient reported quality of life measures after each intervention
* minimum score: 0, maximum score 1.0
* higher score means better outcomeCompare improvement of Bladder outflow obstruction index after prostatic urethral lift versus TURP 5 year Pre- and post-intervention urodynamic will be performed to assess bladder outflow obstruction index (BOOI) as well as subsequent improvement and durability of above stated urodynamic parameter after each intervention
Compare complication rate of prostatic urethral lift versus TURP in BPH patients with urinary retention 5 years To determine the percentage and severity of complications after each intervention (according to the Clavien-Dindo classification)
Compare patient reported symptom measures by IPSS questionnaire after prostatic urethral lift versus TURP 1 year 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 outcomeCompare patient reported symptom measures by IIEF-5 questionnaire after prostatic urethral lift versus TURP 1 year Using the International index of erectile function- 5 items (IIEF-5) questionnaire to determine patient reported symptom measure after each intervention
* minimum score: 1, maximum score: 25
* higher score means better outcomeCompare patient reported quality of life by SF-12 questionnaire after prostatic urethral lift versus TURP 1 year Using the Short Form 12 (SF-12) questionnaire to determine patient reported quality of life measures after each intervention
* minimum score: 0, maximum score: 100
* higher score means better outcomeCompare patient reported recovery by VAS after prostatic urethral lift versus TURP 1 year Using the Visual analogue scale of quality of recovery to determine patient reported recovery after each intervention
* minimum score: 0, maximum score 100
* higher score means better outcome
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Trial Locations
- Locations (1)
Queen Mary Hospital
🇨🇳Hong Kong, China