Actively Recruiting

Phase Not Applicable
Age: 18Years +
MALE
ID03297281

Multicenter Randomized Open-label Trial to Compare Risks of Maintaining Oral Anticoagulation During Laser Surgery for Benign Prostatic Hypertrophy

Led by Clinique Pasteur · Updated on 2026-03-06

389

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

Sponsors

C

Clinique Pasteur

Lead Sponsor

B

Boston Scientific Corporation

Collaborating Sponsor

AI-Summary

What this Trial Is About

Benign prostatic hyperplasia (BPH) is a common condition in aging men, with incidence increasing significantly with age. Medical treatment is the first approach, but surgery becomes necessary for patients who do not respond well or develop complications. This study evaluates whether maintaining oral anticoagulants (OAC), such as Anti Vitamin K or direct oral anticoagulants, during laser photovaporization (PVP) surgery for BPH increases the risk of bleeding compared to discontinuing these medications. It is a multicenter, randomized, open-label study aiming to provide clearer evidence on the safety of OAC use during PVP surgery in patients at surgical risk.

CONDITIONS

Brief Title

Stop or Ongoing Oral Anticoagulation in Patients Undergoing Pvp (SOAP)

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Prostate volume less than or equal to 30 grams
  • Micturition disorders resistant to medical treatment related to BPH and/or complications such as retention or lithiasis
  • Candidate for photovaporization of the prostate
  • Under Anti Vitamin K or direct oral anticoagulants treatment for more than 3 months with an INR between 2 and 3 for AVK
  • Adult male
  • Affiliated to a social security scheme or equivalent
  • Willing and able to comply with study requirements and sign informed consent
Not Eligible

You will not qualify if you...

  • History of prostate cancer
  • Previous pelvic radiotherapy
  • History of urethral stenosis
  • Presence of one or more bladder polyps
  • Use of antiplatelet agents other than aspirin
  • Allergy to heparin or history of heparin-induced thrombocytopenia
  • Use of injectable anticoagulant therapy at baseline
  • Mechanical prosthetic heart valve
  • Stroke, systemic embolism, or transient ischemic attack within past 12 weeks
  • Venous thromboembolism within past 12 weeks
  • Major bleeding within past 6 weeks
  • Severe renal insufficiency with creatinine clearance below 30 mL/min
  • Thrombocytopenia with platelet count below 100 x 10^9/L
  • Life expectancy less than 1 month
  • Conditions impairing compliance such as cognitive or psychiatric disorders or geographic inaccessibility
  • Contraindications to PVP surgery or general anesthesia
  • Persons under legal guardianship
  • Participation in another clinical study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Surgery and Immediate Post-operative Care

Duration - Day 0 (day of surgery) to patient discharge (approximately 3 days after surgery)

Participants undergo photovaporization of the prostate (PVP) surgery while either maintaining or discontinuing oral anticoagulation treatment according to their assigned group.

1 surgical visit and hospital stay of about 3 days

Post-operative Follow-up

Duration - Up to 6 months after surgery

Participants are monitored after surgery to assess complications, functional success, and quality of prostate resection under oral anticoagulant treatment.

Visits at 1 month, 3 months, and 6 months post-surgery

Trial Site Locations

Total: 1 location

1

Clinique Pasteur

Toulouse, France, 31 076

Actively Recruiting

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Research Team

V

Vincent Misraï, Dr

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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Published Research Related To This Trial

Combination therapy with doxazosin and finasteride for benign prostatic hyperplasia in patients with lower urinary tract symptoms and a baseline total prostate volume of 25 ml or greater.

Steven A Kaplan, John D McConnell, Claus G Roehrborn...

https://pubmed.ncbi.nlm.nih.gov/16406915

A Multicenter Randomized Noninferiority Trial Comparing GreenLight-XPS Laser Vaporization of the Prostate and Transurethral Resection of the Prostate for the Treatment of Benign Prostatic Obstruction: Two-yr Outcomes of the GOLIATH Study.

James A Thomas, Andrea Tubaro, Neil Barber...

https://pubmed.ncbi.nlm.nih.gov/26283011

Trends in the Use of the GreenLight Laser in the Surgical Management of Benign Prostatic Obstruction in France Over the Past 10 Years.

Benoit Peyronnet, Jean-Nicolas Cornu, Morgan Rouprêt...

https://pubmed.ncbi.nlm.nih.gov/25605646

Safety and effectiveness of photoselective vaporization of the prostate (PVP) in patients on ongoing oral anticoagulation.

Robin Ruszat, Stephen Wyler, Thomas Forster...

https://pubmed.ncbi.nlm.nih.gov/16945475

EAU Guidelines on the Assessment of Non-neurogenic Male Lower Urinary Tract Symptoms including Benign Prostatic Obstruction.

Christian Gratzke, Alexander Bachmann, Aurelien Descazeaud...

https://pubmed.ncbi.nlm.nih.gov/25613154