PUL vs TURP in BPH Patients With Urinary Retention

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prostatic Urethral Lift Versus Transurethral Resection of Prostate in Benign Prostatic Hyperplasia Patients With Urinary Retention

Conditions
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BPH With Urinary Obstruction

Intervention / Treatment
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* Device: Prostatic Urethral Lift
* Procedure: TURP


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prostatic Urethral Lift<br>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. | Device: Prostatic Urethral Lift<br>* 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<br>* Other names: Urolift;|
| Active Comparator: TURP<br>Transurethral resection of prostate (TURP) will be performed under spinal or general anesthesia as per usual care. | Procedure: TURP<br>* Using monopolar or bipolar loop diathermy via cystoscopy, excess prostate tissue is resected piecemeal to remove obstruction to the prostatic urethra due to BPH<br>* Other names: Transurethral resection of prostate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1 year after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | 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 | 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 | 1 year | 
| Compare patient reported symptom measures by ISI questionnaire after prostatic urethral lift versus TURP | 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 outcome | 1 year | 
| Compare patient reported symptom measures by IIEF-5 questionnaire after prostatic urethral lift versus TURP | 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 outcome | 1 year | 
| Compare patient reported symptom measures by MSHQ-EjD short form questionnaire after prostatic urethral lift versus TURP | Using the Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD) short form questionnaire to determine patient reported symptom measure after each intervention. | 1 year | 
| Compare patient reported quality of life by SF-12 questionnaire after prostatic urethral lift versus TURP | 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 outcome | 1 year | 
| Compare patient reported quality of life by derived SF-6D utility score after prostatic urethral lift versus TURP | 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 outcome | 1 year | 
| Compare patient reported recovery by VAS after prostatic urethral lift versus TURP | 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 | 1 year | 
| Compare improvement bladder contractility index after prostatic urethral lift versus TURP | 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 | 5 year | 
| Compare improvement of Bladder outflow obstruction index after prostatic urethral lift versus TURP | 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 | 5 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BPH, Urinary retention, prostatic urethral lift, PUL, TURP