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

NCT02401581 | Completed

• 1 other identifier: 14-PP-07
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 12

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.

Conditions

Benign Prostatic Hypertrophy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Total dose of energy

  during 24 hours hospitalisation

• The duration of recatherization

  during 24 hours hospitalisation

Study Arms (1)

rate of early removal of the catheter

EXPERIMENTAL

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 .

Other: Catheter

Interventions

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 ... ).

rate of early removal of the catheter

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ;
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (12)

CH Grasse - urologie

Grasse, Alpes-maritimes, 06130, France

Location

CHU de Nice - Urologie

Nice, Alpes-Maritimes, 06200, France

Location

CH privé St Brieuc

Saint-Brieuc, Cote D'armor, 22003, France

Location

APHM - Urologie - Hôpital Conception

Marseille, PACA, 13005, France

Location

CHRU Tours

Tours, Vendée, 37 044, France

Location

CHU Brest Urologie

Brest, 2609, France

Location

CHU Grenoble

Grenoble, 38043, France

Location

CHU Limoges -Urologie - Hôpital Dupuytren

Limoges, 87042, France

Location

Polyclinique les Bleuets

Reims, 51726, France

Location

CHU Rennes

Rennes, 51726, France

Location

AP-HP - Urologie Hôpital Tenon

Paris, Île-de-France Region, 75020, France

Location

Institut Mutualiste Monsouris urologie

Paris, Île-de-France Region, 75674, France

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Catheters

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• DURAND Matthieu, Ph

  Service d'Urologie, CHU de Nice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2014
• First Posted: March 30, 2015
• Study Start: February 2, 2015
• Primary Completion: August 21, 2019
• Study Completion: June 8, 2021
• Last Updated: September 17, 2021

Record last verified: 2021-09

Locations

FR (12)