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

Multicenter Randomized Open-labelled Trial Which Aims to Show Non-inferiority of Adverse Events Risk During the Maintenance of Oral-anticoagulation in the Surgery of Benign Prostatic Hypertrophy by Laser Photovaporization

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.

Study Overview

• Status: Recruiting
• Conditions: Benign Prostatic Hyperplasia; Anticoagulant Adverse Reaction
• Intervention / Treatment: Other: Maintenance of OAC in surgery of BPH by PVP.; Other: Discontinuation of OAC in surgery of BPH by PVP.

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 389
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vincent Misraï, Dr; Phone Number: 05 62 21 33 26; Email: vmisrai@clinique-pasteur.com

Study Locations

• France
  • Toulouse, France, 31 076
    • Recruiting
    • Clinique Pasteur
    • Contact: Vincent Misraï, Dr; Phone Number: 05 62 21 33 26; Email: vmisrai@clinique-pasteur.com
    • Principal Investigator: Nicolas Barry Delongchamps, Dr
    • Principal Investigator: Emmanuel Della Negra, Dr
    • Principal Investigator: Romain Mathieu, Dr
    • Principal Investigator: Gilles Karsenty, Pr
    • Principal Investigator: Charles Ballereau, Dr
    • Principal Investigator: Franck Bruyère, Pr
    • Sub-Investigator: Luc Corbel, Dr
    • Principal Investigator: Sébastien Vincendeau, Dr
    • Sub-Investigator: Gaëlle Fiard, Dr
    • Sub-Investigator: Caroline Thuillier, Dr
    • Sub-Investigator: Pierre Colin, Dr
    • Principal Investigator: Souhil Lebdai, Dr
    • Principal Investigator: Camille Overs, Dr
    • Sub-Investigator: Pierre Bigot, Pr
    • Principal Investigator: Idir Ouzaid, Dr
    • Sub-Investigator: Evanguelos Xylinas, Dr
    • Principal Investigator: Matthieu Durand, Dr
    • Sub-Investigator: Brannwel Tibi, Dr
    • Sub-Investigator: Youness Ahallal, Dr
    • Principal Investigator: Simon Bernardeau, Dr
    • Sub-Investigator: Maxime Vallée, Dr
    • Principal Investigator: Romain Huet, Dr
    • Sub-Investigator: Romain Haider, Dr
    • Sub-Investigator: Héloïse Ducousso, Dr
    • Principal Investigator: Benjamin Pradère, Dr
    • Sub-Investigator: Thibaut Culty, Dr
    • Principal Investigator: Jean-Luc Descotes, Pr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: S1: maintenance; Maintenance of OAC in surgery of BPH by PVP.	Other: Maintenance of OAC in surgery of BPH by PVP.; The maintenance of AVK or DOACs treatment in the perioperative setting (without interruption of oral treatment).
Active Comparator: S2 : discontinuation; Discontinuation of OAC in surgery of BPH by PVP.	Other: Discontinuation of OAC in surgery of BPH by PVP.; The discontinuation of AVK or DOACs treatment with perioperative heparin relay during postoperative course.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	Between day 0 (day of the surgery) and day 30 (1 month after surgery)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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		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		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		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		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		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		At 1 month, 3 months and 6 months

Collaborators and Investigators

• Sponsor: Dr Vincent Misrai
• Collaborators: Boston Scientific Corporation; Iqvia Pty Ltd
• Investigators: Principal Investigator: Vincent Misrai, Dr, Clinique Pasteur

Publications and helpful links

General Publications

• Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.
• Gratzke C, Bachmann A, Descazeaud A, Drake MJ, Madersbacher S, Mamoulakis C, Oelke M, Tikkinen KAO, Gravas S. EAU Guidelines on the Assessment of Non-neurogenic Male Lower Urinary Tract Symptoms including Benign Prostatic Obstruction. Eur Urol. 2015 Jun;67(6):1099-1109. doi: 10.1016/j.eururo.2014.12.038. Epub 2015 Jan 19.
• Rosen R, Altwein J, Boyle P, Kirby RS, Lukacs B, Meuleman E, O'Leary MP, Puppo P, Robertson C, Giuliano F. Lower urinary tract symptoms and male sexual dysfunction: the multinational survey of the aging male (MSAM-7). Eur Urol. 2003 Dec;44(6):637-49. doi: 10.1016/j.eururo.2003.08.015.
• Thomas JA, Tubaro A, Barber N, d'Ancona F, Muir G, Witzsch U, Grimm MO, Benejam J, Stolzenburg JU, Riddick A, Pahernik S, Roelink H, Ameye F, Saussine C, Bruyere F, Loidl W, Larner T, Gogoi NK, Hindley R, Muschter R, Thorpe A, Shrotri N, Graham S, Hamann M, Miller K, Schostak M, Capitan C, Knispel H, Bachmann A. 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. Eur Urol. 2016 Jan;69(1):94-102. doi: 10.1016/j.eururo.2015.07.054. Epub 2015 Aug 15.
• Bachmann A, Tubaro A, Barber N, d'Ancona F, Muir G, Witzsch U, Grimm MO, Benejam J, Stolzenburg JU, Riddick A, Pahernik S, Roelink H, Ameye F, Saussine C, Bruyere F, Loidl W, Larner T, Gogoi NK, Hindley R, Muschter R, Thorpe A, Shrotri N, Graham S, Hamann M, Miller K, Schostak M, Capitan C, Knispel H, Thomas JA. 180-W XPS GreenLight laser vaporisation versus transurethral resection of the prostate for the treatment of benign prostatic obstruction: 6-month safety and efficacy results of a European Multicentre Randomised Trial--the GOLIATH study. Eur Urol. 2014 May;65(5):931-42. doi: 10.1016/j.eururo.2013.10.040. Epub 2013 Nov 11.
• Kaplan SA, McConnell JD, Roehrborn CG, Meehan AG, Lee MW, Noble WR, Kusek JW, Nyberg LM Jr; Medical Therapy of Prostatic Symptoms (MTOPS) Research Group. 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. J Urol. 2006 Jan;175(1):217-20; discussion 220-1. doi: 10.1016/S0022-5347(05)00041-8.
• Misrai V, Roupret M, Guillotreau J, Bordier B, Bruyere F. [Greenlight((R)) photoselective vaporisation for benign prostatic hyperplasia: a systematic review]. Prog Urol. 2013 Feb;23(2):77-87. doi: 10.1016/j.purol.2012.10.013. Epub 2012 Nov 26. French.
• Peyronnet B, Cornu JN, Roupret M, Bruyere F, Misrai V. Trends in the Use of the GreenLight Laser in the Surgical Management of Benign Prostatic Obstruction in France Over the Past 10 Years. Eur Urol. 2015 Jun;67(6):1193-1195. doi: 10.1016/j.eururo.2015.01.003. Epub 2015 Jan 17. No abstract available.
• Ruszat R, Wyler S, Forster T, Reich O, Stief CG, Gasser TC, Sulser T, Bachmann A. Safety and effectiveness of photoselective vaporization of the prostate (PVP) in patients on ongoing oral anticoagulation. Eur Urol. 2007 Apr;51(4):1031-8; discussion 1038-41. doi: 10.1016/j.eururo.2006.08.006. Epub 2006 Aug 18.
• Reich O, Bachmann A, Siebels M, Hofstetter A, Stief CG, Sulser T. High power (80 W) potassium-titanyl-phosphate laser vaporization of the prostate in 66 high risk patients. J Urol. 2005 Jan;173(1):158-60. doi: 10.1097/01.ju.0000146631.14200.d4.
• Charbonneau H, Pathak A, Albenque JP, Misrai V. Greenlight photovaporization of the prostate in patients under rivaroxaban: Lesson learned after the first cases. Prog Urol. 2016 Apr;26(5):273-5. doi: 10.1016/j.purol.2016.02.002. Epub 2016 Mar 9. No abstract available.
• Douketis JD, Spyropoulos AC, Kaatz S, Becker RC, Caprini JA, Dunn AS, Garcia DA, Jacobson A, Jaffer AK, Kong DF, Schulman S, Turpie AG, Hasselblad V, Ortel TL; BRIDGE Investigators. Perioperative Bridging Anticoagulation in Patients with Atrial Fibrillation. N Engl J Med. 2015 Aug 27;373(9):823-33. doi: 10.1056/NEJMoa1501035. Epub 2015 Jun 22.
• Malek RS, Kuntzman RS, Barrett DM. High power potassium-titanyl-phosphate laser vaporization prostatectomy. J Urol. 2000 Jun;163(6):1730-3.
• Peyronnet B, Pradere B, Brichart N, Bodin T, Bertrand P; Members of French Group of GreenLight Users; Bruyere F. Complications associated with photoselective vaporization of the prostate: categorization by a panel of GreenLight users according to Clavien score and report of a single-center experience. Urology. 2014 Sep;84(3):657-64. doi: 10.1016/j.urology.2014.05.028.
• Charbonneau H, Pasquie M, Peyronnet B, Descazeaud A, Barry-Delongchamps N, Della Negra E, Mathieu R, Karsenty G, Long JA, Ballereau C, Azzouzi AR, Pradere B, Bruyere F, Fournier G, Lebdai S, Calves J, Corbel L, Vincendeau S, Fiard G, Thuillier C, Descotes JL, Colin P, Culty T, Hesbois A, Fuzier V, Savy N, Pathak A, Albaladejo P, Samama CM, Guerrero F, Misrai V. Stopping or maintaining oral anticoagulation in patients undergoing photoselective vaporization of the prostate (SOAP) surgery for benign prostate obstruction: study protocol for a multicentre randomized controlled trial. Trials. 2018 Dec 27;19(1):705. doi: 10.1186/s13063-018-3066-9.

Helpful Links

• Access the 06/03/2017.
• Caroline Elie, Emmanuel Touze, Non-inferiority tests, Blood thrombosis vessels 24(2), pp.93-9, 2012.
• Management of overdosage in anti vitamins K, situations with hemorrhagic risk and hemorrhagic accidents in patients treated with anti vitamins K in the city and in hospitals, recommendations High Authority of Health 2008.

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2017
• Primary Completion (Estimated): November 30, 2025
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: September 12, 2017
• First Submitted That Met QC Criteria: September 28, 2017
• First Posted (Actual): September 29, 2017

Study Record Updates

• Last Update Posted (Actual): January 24, 2024
• Last Update Submitted That Met QC Criteria: January 23, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Complication; Oral anticoagulation; Laser; Benign prostatic hyperplasia; Photovaporization
• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: 2017-A01236-47

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No