An interventional study of Maintenance of OAC in surgery of BPH by PVP. and Discontinuation of OAC in surgery of BPH by PVP. in Benign Prostatic Hyperplasia and Anticoagulant Adverse Reaction, sponsored by Clinique Pasteur. Recruiting at 1 site in France. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-06.
Sponsored by Clinique Pasteur · Not applicable, Interventional, and Other
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 risk that new "minimally invasive" surgical techniques have emerged. Thus, lasers have been developed and are currently used as an alternative to the TURP. Used in clinical practice since 2000, prostatic photosensitive vaporization (PVP) relies on the absorption of a 532nm (green) wavelength laser beam by the oxyhemoglobin contained in richly vascularized prostate tissue.
Given the aging of the population, more and more patients are being treated with oral anticoagulants (Anti Vitamin K (AVK) or direct oral anticoagulants (DOACs)). Today there are about 1.4 million people on oral anticoagulants, 40% of whom are over 80 years of age. The peri-operative management of the AVK is currently based on the recommendations published by the FHA (French Health Authority) in 2008. Concerning the perioperative management of DOACs, the perioperative haemostasis interest group (GIHP) made proposals updated in September 2015.
Numerous studies published in the literature have concluded the feasibility of prostate removal surgery by PVP with greenlight laser without relay (or interruption) of AVK or DOACs because of the properties of hemostasis. But the levels of evidence for these studies remain low.
No study has focused on rigorously assessing the perioperative hemorrhagic risk associated with OAC therapy in patients eligible for PVP, and this is the originality of this study.
This study is a multicenter prospective randomized study whose objective is to show that the PVP performed in patients with OAC is not associated with an increase in perioperative hemorrhagic risk.
SOAP is a non-inferiority, multicentric, open-labelled, two parallel arms study.
The expected benefits are to foster and make the perioperative management of OAC safer in patients undergoing BPH surgery with PVP.
Exclusion Criteria:
Maintenance of OAC in surgery of BPH by PVP.
Other: Maintenance of OAC in surgery of BPH by PVP.
Discontinuation of OAC in surgery of BPH by PVP.
Other: Discontinuation of OAC in surgery of BPH by PVP.
The maintenance of AVK or DOACs treatment in the perioperative setting (without interruption of oral treatment).
The discontinuation of AVK or DOACs treatment with perioperative heparin relay during postoperative course.
Number of patients with at least one complication classified higher or equal to grade 2 according to the Clavien classification related to maintenance of oral-anticoagulant (OAC) during the surgical resection of BPH by laser at 1 month
Time frame: Between day 0 (day of the surgery) and day 30 (1 month after surgery)
Number of patients with at least one hemorrhagic complication related to maintenance of oral-anticoagulant (OAC) during the surgical resection of BPH by laser at 1 month, 3 months and 6 months
Haemorrhagic complications are defined by hematuria, bladder clotting removed from patient bed or operating room.
Time frame: At 1 month, 3 months and 6 months
Number of patients with at least one thrombotic complication related to maintenance of oral-anticoagulant (OAC) during the surgical resection of BPH by laser at 1 month, 3 months and 6 months
Thrombotic complications are defined by stroke, transient ischemic attacks and systemic embolisms.
Time frame: At 1 month, 3 months and 6 months
Duration of hospitalization related to perioperative management of anticoagulants will be measured at the patient's discharge
Time frame: At the patient's discharge, on average 3 days after surgery
Prostatic residual volume will be measured to evaluate the quality of resection under oral-anticoagulant at 1 month, 3 months, and 6 months
Time frame: At 1 month, 3 months and 6 months
PSA level will be measured to evaluate the quality of resection under oral-anticoagulant at 1 month, 3 months, and 6 months
Time frame: At 1 month, 3 months and 6 months
Questionnaires International Prostate Symptom Score (IPSS) will be complemented by patients to evaluate the functional success of surgery under oral-anticoagulant at 1 month, 3 months and 6 months
Time frame: At 1 month, 3 months and 6 months
International Continence Society (ICS) will be complemented by patients to evaluate the functional success of surgery under oral-anticoagulant at 1 month, 3 months and 6 months
Time frame: At 1 month, 3 months and 6 months
Volume of post-voiding residue will be measured to evaluate the functional success of surgery under oral-anticoagulant at 1 month, 3 months and 6 months
Time frame: At 1 month, 3 months and 6 months
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Clinique Pasteur