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

Centre Hospitalier Universitaire de Nice

Status: Completed

Conditions: Benign Prostatic Hypertrophy

Treatments: Other: Catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT02401581

14-PP-07

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: Male

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 .

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

rate of early removal of the catheter

Experimental group

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 .

Treatment:

Other: Catheter