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

NCT02401581 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2021-09-17

No results posted yet for this study

Summary

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.

Conditions

  • Benign Prostatic Hypertrophy

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 ... ).

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Nice

    lead OTHER

Principal Investigators

  • DURAND Matthieu, Ph · Service d'Urologie, CHU de Nice

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-02
Primary Completion
2019-08-21
Completion
2021-06-08

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02401581 on ClinicalTrials.gov