Clinical trial NCT02401581: Feasibility Study of Photovaporisation of Prostate With a Limitated Length of Catheterization of 3 Hours
Official title: Study ¨PRECOCE Feasibility Study of Photovaporisation of Prostate With a Limitated Length of Catheterization of 3 Hours
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benign Prostatic Hypertrophy
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2015-03-30
Enrollment: 200
Sex: MALE
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: 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 .

Primary outcomes:
measure: failure rate of a limited catheterization duration of 3 hours post- operative
timeFrame: at three hours post surgery
Secondary outcomes:
measure: Total dose of energy
timeFrame: during 24 hours hospitalisation
measure: The duration of recatherization
timeFrame: during 24 hours hospitalisation
Other outcomes:
Locations:
city: Grasse
country: France
facility: CH Grasse - urologie
state: Alpes-maritimes
city: Nice
country: France
facility: CHU de Nice - Urologie
state: Alpes-Maritimes
city: Saint-Brieuc
country: France
facility: CH privé St Brieuc
state: Cote D'armor
city: Paris
country: France
facility: AP-HP - Urologie Hôpital Tenon
state: Ile De France
city: Paris
country: France
facility: Institut Mutualiste Monsouris urologie
state: Ile De France
city: Marseille
country: France
facility: APHM - Urologie - Hôpital Conception
state: Paca
city: Tours
country: France
facility: CHRU Tours
state: Vendée
city: Brest
country: France
facility: CHU Brest Urologie
city: Grenoble
country: France
facility: CHU Grenoble
city: Limoges
country: France
facility: CHU Limoges -Urologie - Hôpital Dupuytren
city: Reims
country: France
facility: Polyclinique les Bleuets
city: Rennes
country: France
facility: CHU Rennes
Study officials:
affiliation: Service d'Urologie, CHU de Nice
name: DURAND Matthieu, Ph
role: PRINCIPAL_INVESTIGATOR
References: