Feasibility Study of Photovaporisation of Prostate With a Limitated Length of Catheterization of 3 Hours

Study Overview
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Brief Summary
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Benign hypertrophy of the prostate (BPH) is the most frequent pathology in the urinary tract of middle-aged men. In recent years, to enable BPH treatment with larger volumes and to reduce the risk of hemorrhage known to be associated to the transurethral resection of prostate treatment, transurethral photovaporisation of the prostate (PVP ) with the GreenLight (GL) XPS 180 W was developed. Therefore, the question arises to maximally reduce the length of catheterization to facilitate outpatient surgical management of prostate adenoma. In the investigators study, the investigators propose to evaluate the failure rate of an early removal of the catheter 3 hours post-operative after a PVP procedure with GL 180 W/XPS in selected patients on general anesthesia or spinal anesthesia. To this end, the investigators realize a national multicenter prospective study including 300 patients. The effectiveness of this model of management is defined by absence of a need for re-catheterization in the post -operative period of 24 hours.

Official Title
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Study ¨PRECOCE Feasibility Study of Photovaporisation of Prostate With a Limitated Length of Catheterization of 3 Hours

Conditions
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Benign Prostatic Hypertrophy

Intervention / Treatment
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* Other: Catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with lower urinary tract symptoms (LUTS ) IPSS≥ 15 despite medical treatment > 1 month if monotherapy or > 3 months if bitherapie OR acute urinary retention ( RAU ) non-medical after the 1st failure to remove the catheter OR acute prostatitis OR macroscopic haematuria of prostatic origin prostate volume > 30 cc by transrectal ultrasonography ; IPSS Qol ≥ 3 has at inclusion ; PSA ≤ 4 ng / ml ; if PSA between 4 and 10 then PSA L/T ≥25 % or negative PBP <6 months . Accommodation <50 km; company available for the return at home and monitoring first post- operative night . patient sign the informed consent patient covered by social security or other health insurance Exclusion criteria post- voiding residue > 250 cc by suprapubic ultrasound not older than < 45 days prostate volume > 100 cc by transrectal ultrasound not older than 45 days urological antecedents : o urethral stenosis or cervical disease UTI in progress SAD patient or self-catheterization obstructive hydronephrosis + / - renal failure vesical calculi cancer of the prostate treated or untreated bladder tumor associated Interstitial cystitis ( symptom or biopsy) antecedent of the prostate surgery neurologic bladder ( parkinsonian syndrome , multiple sclerosis , lupus, neuropathy, Diabetic, cauda equina syndrome ) criteria related concomitant medications that can not be stopped at least < 48 hours before PVP with GL XPS 180 W contra indication for outpatient care for medical reason contra indication of a product analgesic according to protocol patient inability to understand and sign the informed consent as well as completing the questionnaires ASA Score > 3 .

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 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: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rate of early removal of the catheter<br>In our study, we propose to evaluate the failure rate of an early removal of the catheter 3 hours post-operative after a PVP procedure with GL 180 W/XPS in selected patients on general anesthesia or spinal anesthesia for limiting autonomic effects on the bladder and ensure fastest possible recovery of voiding . | Other: Catheter<br>* The effectiveness of this model of management is defined by absence of a need for re-catheterization in the post -operative period of 24 hours, indications for resondage being cases of acute urinary retention (AUR ) or macroscopic hematuria necessitating a washes with drainage . Patients are followed for a period of 3 months with a post-operative visit at 30 days and a last follow-up visit at 90 days during which the effectiveness is evaluated by conventional means of clinical indicators ( flowmetry , postvoid residue, volumetry of the prostate , IPSS scores , QoL , EVA, IIEF ... ).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| failure rate of a limited catheterization duration of 3 hours post- operative | • The failure rate of a limited catheterization duration of 3 hours post- operative is defined by a need of recatheterizatrion within 24 hours post- GL with PVP XPS 180W . The catheterization remains indicated in case of macroscopic hematuria RAU or if no natural urination is possible | at three hours post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total dose of energy | The total dose of energy delivered to the tissue induring the intervention will be expressed and collected by means of the instrumentation of the GL-XPS console. | during 24 hours hospitalisation | 
| The duration of recatherization | The duration of recatherization is regarded as the total cumulative duration of catheterization regardless of the number of attempts for removale when it is a failure. The average duration of resondage counts only recatheterizations occurring in the first week which may be considered as due to PVP with GL XPS 180W followed by a shortened catheterization of 3 hours post- operatively . The duration of recatherization is defined from the time when it was done in thefirst week post- operative until urinary recovery | during 24 hours hospitalisation |