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

Primary Purpose

Benign Prostatic Hypertrophy

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Catheter
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Benign Prostatic Hypertrophy

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. patients with lower urinary tract symptoms (LUTS )
  2. 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
  3. prostate volume > 30 cc by transrectal ultrasonography ;
  4. IPSS Qol ≥ 3 has at inclusion ;
  5. PSA ≤ 4 ng / ml ;
  6. if PSA between 4 and 10 then PSA L/T ≥25 % or negative PBP <6 months .
  7. Accommodation <50 km;
  8. company available for the return at home and monitoring first post- operative night .
  9. patient sign the informed consent
  10. patient covered by social security or other health insurance

Exclusion criteria

  1. post- voiding residue > 250 cc by suprapubic ultrasound not older than < 45 days
  2. prostate volume > 100 cc by transrectal ultrasound not older than 45 days

  3. 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)
  4. antecedent of the prostate surgery
  5. neurologic bladder ( parkinsonian syndrome , multiple sclerosis , lupus, neuropathy, Diabetic, cauda equina syndrome )
  6. criteria related concomitant medications that can not be stopped at least < 48 hours before PVP with GL XPS 180 W
  7. contra indication for outpatient care for medical reason
  8. contra indication of a product analgesic according to protocol
  9. patient inability to understand and sign the informed consent as well as completing the questionnaires
  10. ASA Score > 3 .

Sites / Locations

  • CH Grasse - urologie
  • CHU de Nice - Urologie
  • CH privé St Brieuc
  • AP-HP - Urologie Hôpital Tenon
  • Institut Mutualiste Monsouris urologie
  • APHM - Urologie - Hôpital Conception
  • CHRU Tours
  • CHU Brest Urologie
  • CHU Grenoble
  • CHU Limoges -Urologie - Hôpital Dupuytren
  • Polyclinique les Bleuets
  • CHU Rennes

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

rate of early removal of the catheter

Arm Description

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 .

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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

Full Information

First Posted
December 1, 2014
Last Updated
September 13, 2021
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT02401581
Brief Title
Feasibility Study of Photovaporisation of Prostate With a Limitated Length of Catheterization of 3 Hours
Acronym
PRECOCE
Official Title
Study ¨PRECOCE Feasibility Study of Photovaporisation of Prostate With a Limitated Length of Catheterization of 3 Hours
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
February 2, 2015 (Actual)
Primary Completion Date
August 21, 2019 (Actual)
Study Completion Date
June 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hypertrophy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rate of early removal of the catheter
Arm Type
Experimental
Arm Description
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 .
Intervention Type
Other
Intervention Name(s)
Catheter
Intervention Description
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 ... ).
Primary Outcome Measure Information:
Title
failure rate of a limited catheterization duration of 3 hours post- operative
Description
• 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
Time Frame
at three hours post surgery
Secondary Outcome Measure Information:
Title
Total dose of energy
Description
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.
Time Frame
during 24 hours hospitalisation
Title
The duration of recatherization
Description
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
Time Frame
during 24 hours hospitalisation

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 .
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
DURAND Matthieu, Ph
Organizational Affiliation
Service d'Urologie, CHU de Nice
Official's Role
Principal Investigator
Facility Information:
Facility Name
CH Grasse - urologie
City
Grasse
State/Province
Alpes-maritimes
ZIP/Postal Code
06130
Country
France
Facility Name
CHU de Nice - Urologie
City
Nice
State/Province
Alpes-Maritimes
ZIP/Postal Code
06200
Country
France
Facility Name
CH privé St Brieuc
City
Saint-Brieuc
State/Province
Cote D'armor
ZIP/Postal Code
22003
Country
France
Facility Name
AP-HP - Urologie Hôpital Tenon
City
Paris
State/Province
Ile De France
ZIP/Postal Code
75020
Country
France
Facility Name
Institut Mutualiste Monsouris urologie
City
Paris
State/Province
Ile De France
ZIP/Postal Code
75674
Country
France
Facility Name
APHM - Urologie - Hôpital Conception
City
Marseille
State/Province
Paca
ZIP/Postal Code
13005
Country
France
Facility Name
CHRU Tours
City
Tours
State/Province
Vendée
ZIP/Postal Code
37 044
Country
France
Facility Name
CHU Brest Urologie
City
Brest
ZIP/Postal Code
2609
Country
France
Facility Name
CHU Grenoble
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
CHU Limoges -Urologie - Hôpital Dupuytren
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Polyclinique les Bleuets
City
Reims
ZIP/Postal Code
51726
Country
France
Facility Name
CHU Rennes
City
Rennes
ZIP/Postal Code
51726
Country
France

12. IPD Sharing Statement

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

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