TRP Versus Photo Selective Vaporization for Obstructive Benign Prostatic Hyperplasia Management

Not Applicable

Completed

• Conditions: Benign Prostatic Hyperplasia
• Interventions: Procedure: TURP; Procedure: PVP

• Registration Number: NCT01043588
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Detailed 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.

Study Timeline

• Study Start: 2007-11
• Primary Completion: 2009-12
• Study First Submitted: 2009-12-21
• Study First Submitted QC: 2010-01-06
• Study First Posted: 2010-01-07
• Study Completion: 2011-02
• Status Verified: 2012-12
• Last Update Submitted: 2013-04-30
• Last Update Posted: 2013-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 142

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 : TURP	TURP	Surgery: TransUrethral Resection of the Prostate
2 : PVP	PVP	Surgery: Photo selective Vaporization of the Prostate

Primary Outcome Measures

Name	Time	Method
Hospital stay	end of hospitalization
Clinical symptoms at 1-yr follow-up evaluated with usual objective and subjective parameters	at one year

Secondary Outcome Measures

Name	Time	Method
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
Evaluation of quality of life	during follow up

Trial Locations

Locations (1)

Hôpital TENON - Service d'Urologie; 🇫🇷 Paris, France