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NCT Number: NCT02401581

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

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.

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Key information

Conditions

Benign Prostatic Hypertrophy Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

45 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nice - Urologie, Nice, Alpes-Maritimes, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 .

Treatment and study plan

Catheter

Other

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 outcomes

  1. failure rate of a limited catheterization duration of 3 hours post- operative

    Time frame: at three hours post surgery

    • 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 outcomes

  1. Total dose of energy

    Time frame: during 24 hours hospitalisation

    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.

  2. The duration of recatherization

    Time frame: during 24 hours hospitalisation

    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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

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

Acronym: PRECOCE

Important dates

Study start
2015
Primary completion
2019
Study completion
2021
First posted
Mar 30, 2015
Registry last updated
Sep 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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