Skip to main content
OpenTrials
Completed

NCT Number: NCT01043588

TRP Versus Photo Selective Vaporization for Obstructive Benign Prostatic Hyperplasia Management

The aim of this study is to compare medical efficacy and cost effectiveness of two surgical options for obstructive BPH management : transurethral resection of the prostate with photo selective vaporization of the prostate using the high powered 532nm laser.

Completed

Looking for future studies?

Notify Me

Key information

Age range

50 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital TENON - Service d'Urologie

Paris, 75020, France

About this study

The aim of this study is to compare medical efficacy and cost effectiveness of two surgical options for obstructive BPH management : transurethral resection of the prostate with photo selective vaporization of the prostate using the high powered 532nm laser. Patients were randomized in two groups after inclusion. Perioperative data were collected, and follow-up was conducted for one month.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male, 50 years of age or older.
  • American Society of Anesthesiology (ASA) classification of physical status, class 1-3
  • Signed an informed consent at the beginning of the study.
  • Patients presenting with LUTS associated to benign prostatic enlargement for more than 3 months, needing a surgical management, with at least one of the following situations: disability score ≥3, I-PSS ≥12, or full urinary retention
  • Qmax ≤12ml /s for no drained patients with voided volume> 125 ml.
  • Estimated prostate weight between 25g and 80g
  • Patient free of catheter with PVR ≤ 300cc
  • Patient without renal disorders.
  • No prostate cancer suspicion at clinical examination, including DRE.
  • PSA ≤ 10 ng/ml, with negative prostate biopsies of PSA is between 4 and 10 ng/mL if patient is 75 years or younger or has a life expectancy of more than 10 years.
  • In case of anticoagulation or anti-aggregation therapy, necessary preoperative visit by anaesthesiologist to determine the supply therapy around surgery.
  • In case of current BPH medical management, alpha blockers and herbal medicines should be stopped one week before surgery and 5-alpha-reductase-inhibitors should be stopped one month before surgery.
  • Patient must be affiliated to the French social healthcare or equivalent

Exclusion criteria

  • Uncontrolled cardiopulmonary disorder, previously or recently diagnosed by standard methods
  • Assessed sphincter detrusor dyssynergia, or myasthenia, multiple sclerosis, or Parkinson disease.
  • History of pelvic lesions with abdominal sphincter injury.
  • Urinary tract infection without antibiotics.
  • Patient with urinary catheter or suprapubic catheter because of an acute urinary retention linked to an alternative diagnosis or impaired bladder sensation.
  • Subject with neurogenic bladder and/or sphincter abnormalities
  • Subject with confirmed or suspected malignancy of the prostate or the bladder.
  • Previous prostatic surgery.
  • History of bladder stone, major hematuria, urethral stricture, bladder neck stenosis.
  • Patient having a prosthesis in the procedure area
  • Patient with an active anorectal disease
  • Treatment emergency
  • Individual unable to respect timing and visits determined by the protocol.
  • Constitutional hemostasis and coagulation abnormalities not linked to oral medications
  • Any disease or patient condition which can be a contra indication to his enrolment in the study, according to the investigator.

Treatment and study plan

TURP

Procedure

TransUrethral Resection of the Prostate

PVP

Procedure

Photo selective Vaporization of the Prostate

Primary outcomes

  1. Hospital stay

    Time frame: end of hospitalization

  2. Clinical symptoms at 1-yr follow-up evaluated with usual objective and subjective parameters

    Time frame: at one year

Secondary outcomes

  1. Rate of complication needing re-hospitalisation or reintervention

    Time frame: from the surgical procedure until one year follow-up

  2. Risk of ignoring a localized prostate cancer needing a curative management.

    Time frame: at one year

  3. Total and post-operative costs during follow-up.

    Time frame: from the surgical procedure until one year follow-up

  4. Evaluation of side effects during follow-up.

    Time frame: from the surgical procedure until one year follow-up

  5. Patient satisfaction

    Time frame: during follow up

  6. Evaluation of quality of life

    Time frame: during follow up

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • American Medical Systems
  • Ministry of Health, France

Registry information

Official study title

Transurethral Resection of the Prostate With Photo Selective Vaporization of the Prostate Using the High Powered 532nm Laser Obstructive Benign Prostatic Hyperplasia Management: Focus on Efficiency and Cost-effectiveness

Acronym: REVAPRO

Important dates

Study start
2007
Primary completion
2009
Study completion
2011
First posted
Jan 7, 2010
Registry last updated
May 1, 2013

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.

Published trials that share one or more normalized conditions with this study.