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

Benign Prostatic Hypertrophy Clinical Trial

— PRECOCE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02401581
• Other study ID #: 14-PP-07
• Status: Completed
• Phase: N/A
• Start date: February 2, 2015
• Est. completion date: June 8, 2021

Study information

• Verified date: September 2021
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 8, 2021
• Est. primary completion date: August 21, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years to 80 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Benign Prostatic Hypertrophy
• Hypertrophy
• Prostatic Hyperplasia

Intervention

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 ... ).

Locations

Country	Name	City	State
France	CHU Brest Urologie	Brest
France	CH Grasse - urologie	Grasse	Alpes-maritimes
France	CHU Grenoble	Grenoble
France	CHU Limoges -Urologie - Hôpital Dupuytren	Limoges
France	APHM - Urologie - Hôpital Conception	Marseille	Paca
France	CHU de Nice - Urologie	Nice	Alpes-Maritimes
France	AP-HP - Urologie Hôpital Tenon	Paris	Ile De France
France	Institut Mutualiste Monsouris urologie	Paris	Ile De France
France	Polyclinique les Bleuets	Reims
France	CHU Rennes	Rennes
France	CH privé St Brieuc	Saint-Brieuc	Cote D'armor
France	CHRU Tours	Tours	Vendée

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	at three hours post surgery
Secondary	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.	during 24 hours hospitalisation
Secondary	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	during 24 hours hospitalisation