TRP Versus Photo Selective Vaporization for Obstructive Benign Prostatic Hyperplasia Management

Benign Prostatic Hyperplasia Clinical Trial

— REVAPRO  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01043588
• Other study ID #: K060401
• Status: Completed
• Phase: N/A
• First received: December 21, 2009
• Last updated: April 30, 2013
• Start date: November 2007
• Est. completion date: February 2011

Study information

• Verified date: December 2012
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: February 2011
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

1. Male, 50 years of age or older.

2. American Society of Anesthesiology (ASA) classification of physical status, class 1-3

3. Signed an informed consent at the beginning of the study.

4. 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

5. Qmax =12ml /s for no drained patients with voided volume> 125 ml.

6. Estimated prostate weight between 25g and 80g

7. Patient free of catheter with PVR = 300cc

8. Patient without renal disorders.

9. No prostate cancer suspicion at clinical examination, including DRE.

10. 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.

11. In case of anticoagulation or anti-aggregation therapy, necessary preoperative visit by anaesthesiologist to determine the supply therapy around surgery.

12. 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.

13. Patient must be affiliated to the French social healthcare or equivalent

Exclusion Criteria:

1. Uncontrolled cardiopulmonary disorder, previously or recently diagnosed by standard methods

2. Assessed sphincter detrusor dyssynergia, or myasthenia, multiple sclerosis, or Parkinson disease.

3. History of pelvic lesions with abdominal sphincter injury.

4. Urinary tract infection without antibiotics.

5. Patient with urinary catheter or suprapubic catheter because of an acute urinary retention linked to an alternative diagnosis or impaired bladder sensation.

6. Subject with neurogenic bladder and/or sphincter abnormalities

7. Subject with confirmed or suspected malignancy of the prostate or the bladder.

8. Previous prostatic surgery.

9. History of bladder stone, major hematuria, urethral stricture, bladder neck stenosis.

10. Patient having a prosthesis in the procedure area

11. Patient with an active anorectal disease

12. Treatment emergency

13. Individual unable to respect timing and visits determined by the protocol.

14. Constitutional hemostasis and coagulation abnormalities not linked to oral medications

15. Any disease or patient condition which can be a contra indication to his enrolment in the study, according to the investigator.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Procedure:
• TURP
TransUrethral Resection of the Prostate
• PVP
Photo selective Vaporization of the Prostate

Locations

Country	Name	City	State
France	Hôpital TENON - Service d'Urologie	Paris

Sponsors (3)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	American Medical Systems, Ministry of Health, France

Country where clinical trial is conducted

France, 

References & Publications (1)

Bachmann A, Schürch L, Ruszat R, Wyler SF, Seifert HH, Müller 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. Epub 2005 Jul 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital stay		end of hospitalization	No
Primary	Clinical symptoms at 1-yr follow-up evaluated with usual objective and subjective parameters		at one year	No
Secondary	Rate of complication needing re-hospitalisation or reintervention		from the surgical procedure until one year follow-up	Yes
Secondary	Risk of ignoring a localized prostate cancer needing a curative management.		at one year	Yes
Secondary	Total and post-operative costs during follow-up.		from the surgical procedure until one year follow-up	No
Secondary	Evaluation of side effects during follow-up.		from the surgical procedure until one year follow-up	Yes
Secondary	Patient satisfaction		during follow up	No
Secondary	Evaluation of quality of life		during follow up	No