Trial Synopsis

Feasibility Study of Photovaporisation of Prostate With a Limitated
Length of Catheterization of 3 Hours
Status: Recruiting
Study Phase: N/A
Start Date: February 2015 | Completion Date: September 2016
Condition(s): Benign Prostatic Hypertrophy
Full Title of Study
Study ¨PRECOCE Feasibility Study of Photovaporisation of Prostate With a Limitated
Length of Catheterization of 3 Hours
Overview
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.
Study Details
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment, Masking: Open Label,
Primary Purpose: Prevention
Investigator Details
Lead Sponsor: Centre Hospitalier Universitaire de Nice
Principal Investigator: DURAND Matthieu, Ph Service d'Urologie, CHU de Nice
Trial Location Details
Facility: CH Grasse - urologie Grasse, France
Sub-Investigator: Colomb Fréderic, Ph
Facility: CHU de Nice - Urologie Nice, France
Principal Investigator: Durand Matthieu, Ph
Sub-Investigator: Marseau Alexandre
Facility: AP-HP - Urologie Hôpital Tenon Paris, France
Sub-Investigator: Cornu Jean-Nicolas, Ph
Facility: Institut Mutualiste Monsouris urologie Paris, France
Sub-Investigator: Barret Eric, Ph
Facility: APHM - Urologie - Hôpital Conception Marseille, France
Sub-Investigator: Karsenty Gilles, PhD
Facility: CHRU Tours Tours, France
Sub-Investigator: Bruyere Franck, PhD
Facility: CHU Brest Urologie Brest, France
Sub-Investigator: Fournier Georges, PhD
Facility: CHU Grenoble Grenoble, France
Sub-Investigator: Thuillier Caroline
Facility: CHU Limoges -Urologie - Hôpital Dupuytren Limoges, France
Sub-Investigator: Descazeaud Auréline, PhD
Facility: Polyclinique les Bleuets Reims, France
Sub-Investigator: Staerman Frederic, Ph
Facility: CHU Rennes Rennes, France
Sub-Investigator: Vincendeau Sébastien, PHD
Facility: CH privé St Brieuc St Brieux, France
Sub-Investigator: Della-Negra Emmanuel, PhD
Interventions
Other: Catheter
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 ... ).
Information Source
ID Number: 14-PP-07
NCT Identifier: NCT02401581
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Full Source of Clinical Trial Data: https://clinicaltrials.gov/show/NCT02401581
ClinicalTrials.gov processed this data on September 28, 2016
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