TRP Versus Photo Selective Vaporization for Obstructive Benign Prostatic Hyperplasia Management

NCT01043588 | Completed

• 1 other identifier: K060401
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Benign Prostatic Hyperplasia

Keywords

Surgery; Prostate; Laser 532 nm; Photo selective Vaporization of the Prostate (PVP); TransUrethral Resection of the Prostate (TURP); Men health

Outcome Measures

Primary Outcomes (2)

• Hospital stay

  end of hospitalization

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

  at one year

Secondary Outcomes (6)

• Rate of complication needing re-hospitalisation or reintervention

  from the surgical procedure until one year follow-up

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

  at one year

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

  from the surgical procedure until one year follow-up

• Evaluation of side effects during follow-up.

  from the surgical procedure until one year follow-up

• Patient satisfaction

  during follow up

Study Arms (2)

1 : TURP

OTHER

Surgery: TransUrethral Resection of the Prostate

Procedure: TURP

2 : PVP

OTHER

Surgery: Photo selective Vaporization of the Prostate

Procedure: PVP

Interventions

TURP PROCEDURE

TransUrethral Resection of the Prostate

1 : TURP

PVP PROCEDURE

Photo selective Vaporization of the Prostate

2 : PVP

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Ministry of Health, France: collaborator
• American Medical Systems: collaborator

Study Sites (1)

Hôpital TENON - Service d'Urologie

Paris, 75020, France

Location

Related Publications (2)

• Bachmann A, Schurch L, Ruszat R, Wyler SF, Seifert HH, Muller A, Lehmann K, Sulser T. Photoselective vaporization (PVP) versus transurethral resection of the prostate (TURP): a prospective bi-centre study of perioperative morbidity and early functional outcome. Eur Urol. 2005 Dec;48(6):965-71; discussion 972. doi: 10.1016/j.eururo.2005.07.001. Epub 2005 Jul 18.

  PMID: 16126327 BACKGROUND

• Lukacs B, Loeffler J, Bruyere F, Blanchet P, Gelet A, Coloby P, De la Taille A, Lemaire P, Baron JC, Cornu JN, Aout M, Rousseau H, Vicaut E; REVAPRO Study Group. Photoselective vaporization of the prostate with GreenLight 120-W laser compared with monopolar transurethral resection of the prostate: a multicenter randomized controlled trial. Eur Urol. 2012 Jun;61(6):1165-73. doi: 10.1016/j.eururo.2012.01.052. Epub 2012 Feb 8.

  PMID: 22341632 DERIVED

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Transurethral Resection of Prostate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Prostatectomy; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Bertrand LUKACS, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2009
• First Posted: January 7, 2010
• Study Start: November 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: February 1, 2011
• Last Updated: May 1, 2013

Record last verified: 2012-12

Locations

FR (1)