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

RecruitingNAAges 18 Years - anyMaleClinique Pasteur
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In plain words

What the trial is, and whether it could suit you

Benign prostatic hyperplasia (BPH) is a very common pathology of the aging man with an incidence that rises from 40% in men aged 50 to 60 years to 90% in men over 80 years. Studies such as the MTOPS (the Medical Therapy of Prostatic Symptoms) study show that more than half of the patients recruited had an aggravation of their disease over time either by an increase in symptoms or by the appearance of complications such as acute retention of urine. For benign symptomatic prostate hypertrophy, apart from any complication, first-line treatment is now a medical treatment. For patients who respond poorly to medical treatment or who have complications related to benign prostatic hypertrophy, the treatment becomes surgical. The reference treatment is endoscopic prostate resection (TURP). It is mainly to improve the safety of hemostasis in patients older and older and at significant surgical ri

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Prostate volume \< or = 30 gr * Micturition disorders resistant to medical treatment related to HBP and/or complications related to BPH (retention, lithiasis...) * Patient candidate for photovaporization of the prostate * Patient under treatment AVK (Anti Vitamin K) for more than 3 months with an objective of INR (International Normalized Ratio) between 2 and 3 or patient under DOACs (Direct Oral Anti-coagulants) for more than 3 months * Unprotected major * Patient affiliated to a social security scheme or equivalent * Patient is willing and able to comply with all study requirements and to sign a study-specific informed consent form. Exclusion Criteria: * History of prostate cancer * Previous pelvic radiotherapy * History of stenosis of the urethra * Patient with one or more bladder polyps * Patient under antiplatelet agent other than aspirin * Allergy to heparin or history of heparin-induced thrombocytopenia * Patients under anticoagulant injectable therapy at baseline (heparin, LMWH (Low Molecular Weight Heparin), fondaparinux) * Any mechanical prosthetic heart valve * Stroke (ischemic or hemorrhagic), systemic embolism or transient ischemic attack within past 12 weeks * Venous thromboembolism (deep vein thrombosis and/or pulmonary embolism) within past 12 weeks * Major bleeding within past 6 weeks * Severe renal insufficiency (calculated creatinine clearance \< 30 mL / min) * Thrombocytopenia (platelet count \< 100 x 10\^9 / L) * Life expectancy \< 1 month * Condition that impairs compliance with trial protocol (e.g. cognitive impairment, uncontrolled psychiatric condition, geographic inaccessibility) * Contra-indication to PVP surgery or contra-indication to general anesthesia * Protected patients : majors under some form of guardianship * Patient participating in another clinical study
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What it tests

  • Maintenance of OAC in surgery of BPH by PVP.
  • Discontinuation of OAC in surgery of BPH by PVP.
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Where

1 site
Clinique Pasteur
Toulouse, France
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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