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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rate of early removal of the catheter | Experimental | 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 . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Catheter | Other | 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 ... ). |
| 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 |
| 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 |
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Inclusion Criteria:
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
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 .
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| Name | Affiliation | Role |
|---|---|---|
| DURAND Matthieu, Ph | Service d'Urologie, CHU de Nice | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH Grasse - urologie | Grasse | Alpes-maritimes | 06130 | France | ||
| CHU de Nice - Urologie |
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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 |
| Nice |
| Alpes-Maritimes |
| 06200 |
| France |
| CH privé St Brieuc | Saint-Brieuc | Cote D'armor | 22003 | France |
| APHM - Urologie - Hôpital Conception | Marseille | PACA | 13005 | France |
| CHRU Tours | Tours | Vendée | 37 044 | France |
| CHU Brest Urologie | Brest | 2609 | France |
| CHU Grenoble | Grenoble | 38043 | France |
| CHU Limoges -Urologie - Hôpital Dupuytren | Limoges | 87042 | France |
| Polyclinique les Bleuets | Reims | 51726 | France |
| CHU Rennes | Rennes | 51726 | France |
| AP-HP - Urologie Hôpital Tenon | Paris | Île-de-France Region | 75020 | France |
| Institut Mutualiste Monsouris urologie | Paris | Île-de-France Region | 75674 | France |
| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D057785 | Catheters |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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