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

NCT ID: NCT02401581

Last Updated: 2021-09-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-02
• Study Completion Date: 2021-06-08

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

rate of early removal of the catheter

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 .

Group Type: EXPERIMENTAL

Catheter

Intervention Type: 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 ... ).

Interventions

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 ... ).

Intervention Type: OTHER

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 .

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

DURAND Matthieu, Ph

Role: PRINCIPAL_INVESTIGATOR

Service d'Urologie, CHU de Nice

Locations

CH Grasse - urologie

Grasse, Alpes-maritimes, France

CHU de Nice - Urologie

Nice, Alpes-Maritimes, France

CH privé St Brieuc

Saint-Brieuc, Cote D'armor, France

APHM - Urologie - Hôpital Conception

Marseille, PACA, France

CHRU Tours

Tours, Vendée, France

CHU Brest Urologie

Brest, , France

CHU Grenoble

Grenoble, , France

CHU Limoges -Urologie - Hôpital Dupuytren

Limoges, , France

Polyclinique les Bleuets

Reims, , France

CHU Rennes

Rennes, , France

AP-HP - Urologie Hôpital Tenon

Paris, Île-de-France Region, France

Institut Mutualiste Monsouris urologie

Paris, Île-de-France Region, France

Countries

France

Other Identifiers

14-PP-07

Identifier Type: -

Identifier Source: org_study_id