<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03297281</url>
  </required_header>
  <id_info>
    <org_study_id>2017-A01236-47</org_study_id>
    <nct_id>NCT03297281</nct_id>
  </id_info>
  <brief_title>Stop or Ongoing Oral Anticoagulation in Patients Undergoing Pvp (SOAP)</brief_title>
  <acronym>SOAP</acronym>
  <official_title>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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dr Vincent Misrai</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Boston Scientific Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Iqvia Pty Ltd</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Clinique Pasteur</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Benign prostatic hyperplasia (BPH) is a very common pathology of the aging man with an&#xD;
      incidence that rises from 40% in men aged 50 to 60 years to 90% in men over 80 years. Studies&#xD;
      such as the MTOPS (the Medical Therapy of Prostatic Symptoms) study show that more than half&#xD;
      of the patients recruited had an aggravation of their disease over time either by an increase&#xD;
      in symptoms or by the appearance of complications such as acute retention of urine.&#xD;
&#xD;
      For benign symptomatic prostate hypertrophy, apart from any complication, first-line&#xD;
      treatment is now a medical treatment. For patients who respond poorly to medical treatment or&#xD;
      who have complications related to benign prostatic hypertrophy, the treatment becomes&#xD;
      surgical. The reference treatment is endoscopic prostate resection (TURP). It is mainly to&#xD;
      improve the safety of hemostasis in patients older and older and at significant surgical risk&#xD;
      that new &quot;minimally invasive&quot; surgical techniques have emerged. Thus, lasers have been&#xD;
      developed and are currently used as an alternative to the TURP. Used in clinical practice&#xD;
      since 2000, prostatic photosensitive vaporization (PVP) relies on the absorption of a 532nm&#xD;
      (green) wavelength laser beam by the oxyhemoglobin contained in richly vascularized prostate&#xD;
      tissue.&#xD;
&#xD;
      Given the aging of the population, more and more patients are being treated with oral&#xD;
      anticoagulants (Anti Vitamin K (AVK) or direct oral anticoagulants (DOACs)). Today there are&#xD;
      about 1.4 million people on oral anticoagulants, 40% of whom are over 80 years of age. The&#xD;
      peri-operative management of the AVK is currently based on the recommendations published by&#xD;
      the FHA (French Health Authority) in 2008. Concerning the perioperative management of DOACs,&#xD;
      the perioperative haemostasis interest group (GIHP) made proposals updated in September 2015.&#xD;
&#xD;
      Numerous studies published in the literature have concluded the feasibility of prostate&#xD;
      removal surgery by PVP with greenlight laser without relay (or interruption) of AVK or DOACs&#xD;
      because of the properties of hemostasis. But the levels of evidence for these studies remain&#xD;
      low.&#xD;
&#xD;
      No study has focused on rigorously assessing the perioperative hemorrhagic risk associated&#xD;
      with OAC therapy in patients eligible for PVP, and this is the originality of this study.&#xD;
&#xD;
      This study is a multicenter prospective randomized study whose objective is to show that the&#xD;
      PVP performed in patients with OAC is not associated with an increase in perioperative&#xD;
      hemorrhagic risk.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      SOAP is a non-inferiority, multicentric, open-labelled, two parallel arms study.&#xD;
&#xD;
      The expected benefits are to foster and make the perioperative management of OAC safer in&#xD;
      patients undergoing BPH surgery with PVP.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 30, 2017</start_date>
  <completion_date type="Anticipated">May 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>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</measure>
    <time_frame>Between day 0 (day of the surgery) and day 30 (1 month after surgery)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>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</measure>
    <time_frame>At 1 month, 3 months and 6 months</time_frame>
    <description>Haemorrhagic complications are defined by hematuria, bladder clotting removed from patient bed or operating room.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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</measure>
    <time_frame>At 1 month, 3 months and 6 months</time_frame>
    <description>Thrombotic complications are defined by stroke, transient ischemic attacks and systemic embolisms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of hospitalization related to perioperative management of anticoagulants will be measured at the patient's discharge</measure>
    <time_frame>At the patient's discharge, on average 3 days after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prostatic residual volume will be measured to evaluate the quality of resection under oral-anticoagulant at 1 month, 3 months, and 6 months</measure>
    <time_frame>At 1 month, 3 months and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PSA level will be measured to evaluate the quality of resection under oral-anticoagulant at 1 month, 3 months, and 6 months</measure>
    <time_frame>At 1 month, 3 months and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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</measure>
    <time_frame>At 1 month, 3 months and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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</measure>
    <time_frame>At 1 month, 3 months and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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</measure>
    <time_frame>At 1 month, 3 months and 6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">389</enrollment>
  <condition>Benign Prostatic Hyperplasia</condition>
  <condition>Anticoagulant Adverse Reaction</condition>
  <arm_group>
    <arm_group_label>S1: maintenance</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Maintenance of OAC in surgery of BPH by PVP.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>S2 : discontinuation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Discontinuation of OAC in surgery of BPH by PVP.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Maintenance of OAC in surgery of BPH by PVP.</intervention_name>
    <description>The maintenance of AVK or DOACs treatment in the perioperative setting (without interruption of oral treatment).</description>
    <arm_group_label>S1: maintenance</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Discontinuation of OAC in surgery of BPH by PVP.</intervention_name>
    <description>The discontinuation of AVK or DOACs treatment with perioperative heparin relay during postoperative course.</description>
    <arm_group_label>S2 : discontinuation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Prostate volume &lt; or = 30 gr&#xD;
&#xD;
          -  Micturition disorders resistant to medical treatment related to HBP and/or&#xD;
             complications related to BPH (retention, lithiasis...)&#xD;
&#xD;
          -  Patient candidate for photovaporization of the prostate&#xD;
&#xD;
          -  Patient under treatment AVK (Anti Vitamin K) for more than 3 months with an objective&#xD;
             of INR (International Normalized Ratio) between 2 and 3 or patient under DOACs (Direct&#xD;
             Oral Anti-coagulants) for more than 3 months&#xD;
&#xD;
          -  Unprotected major&#xD;
&#xD;
          -  Patient affiliated to a social security scheme or equivalent&#xD;
&#xD;
          -  Patient is willing and able to comply with all study requirements and to sign a&#xD;
             study-specific informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of prostate cancer&#xD;
&#xD;
          -  Previous pelvic radiotherapy&#xD;
&#xD;
          -  History of stenosis of the urethra&#xD;
&#xD;
          -  Patient with one or more bladder polyps&#xD;
&#xD;
          -  Patient under antiplatelet agent other than aspirin&#xD;
&#xD;
          -  Allergy to heparin or history of heparin-induced thrombocytopenia&#xD;
&#xD;
          -  Patients under anticoagulant injectable therapy at baseline (heparin, LMWH (Low&#xD;
             Molecular Weight Heparin), fondaparinux)&#xD;
&#xD;
          -  Any mechanical prosthetic heart valve&#xD;
&#xD;
          -  Stroke (ischemic or hemorrhagic), systemic embolism or transient ischemic attack&#xD;
             within past 12 weeks&#xD;
&#xD;
          -  Venous thromboembolism (deep vein thrombosis and/or pulmonary embolism) within past 12&#xD;
             weeks&#xD;
&#xD;
          -  Major bleeding within past 6 weeks&#xD;
&#xD;
          -  Severe renal insufficiency (calculated creatinine clearance &lt; 30 mL / min)&#xD;
&#xD;
          -  Thrombocytopenia (platelet count &lt; 100 x 10^9 / L)&#xD;
&#xD;
          -  Life expectancy &lt; 1 month&#xD;
&#xD;
          -  Condition that impairs compliance with trial protocol (e.g. cognitive impairment,&#xD;
             uncontrolled psychiatric condition, geographic inaccessibility)&#xD;
&#xD;
          -  Contra-indication to PVP surgery or contra-indication to general anesthesia&#xD;
&#xD;
          -  Protected patients : majors under some form of guardianship&#xD;
&#xD;
          -  Patient participating in another clinical study&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vincent Misrai, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinique Pasteur</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Vincent Misraï, Dr</last_name>
    <phone>05 62 21 33 26</phone>
    <email>vmisrai@clinique-pasteur.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Clinique Pasteur</name>
      <address>
        <city>Toulouse</city>
        <zip>31 076</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vincent Misraï, Dr</last_name>
      <phone>05 62 21 33 26</phone>
      <email>vmisrai@clinique-pasteur.com</email>
    </contact>
    <investigator>
      <last_name>Nicolas Barry Delongchamps, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Emmanuel Della Negra, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Romain Mathieu, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Gilles Karsenty, Pr</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jean Alexandre Long, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Charles Ballereau, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Franck Bruyère, Pr</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Luc Corbel, Dr</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sébastien Vincendeau, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Gaëlle Fiard, Dr</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Caroline Thuillier, Dr</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jean-Luc Descotes, Pr</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Pierre Colin, Dr</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Souhil Lebdai, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Camille Overs, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Pierre Bigot, Pr</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Idir Ouzaid, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Evanguelos Xylinas, Dr</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Matthieu Durand, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Brannwel Tibi, Dr</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Youness Ahallal, Dr</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Simon Bernardeau, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Maxime Vallée, Dr</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Romain Huet, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Romain Haider, Dr</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Héloïse Ducousso, Dr</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Benjamin Pradère, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Thibaut Culty, Dr</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <link>
    <url>http://sfar.org/wp-content/uploads/2015/09/Reactualisation-GIHP_AOD_actes-programmes_Septembre-20151.pdf</url>
    <description>Access the 06/03/2017.</description>
  </link>
  <link>
    <url>http://www.jle.com/fr/revues/stv/e-docs/les_essais_de_non_inferiorite_292550/article.phtml</url>
    <description>Caroline Elie, Emmanuel Touze, Non-inferiority tests, Blood thrombosis vessels 24(2), pp.93-9, 2012.</description>
  </link>
  <link>
    <url>http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003658.pdf</url>
    <description>Access the 06/03/2017.</description>
  </link>
  <link>
    <url>https://www.has-sante.fr/portail/upload/docs/application/pdf/2008-09/surdosage_en_avk_situations_a_risque_et_accidents_hemorragiques_-_synthese_des_recommandations_v2.pdf</url>
    <description>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.</description>
  </link>
  <reference>
    <citation>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.</citation>
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    <citation>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.</citation>
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    <citation>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.</citation>
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    <citation>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.</citation>
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    <citation>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.</citation>
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    <citation>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.</citation>
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    <citation>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.</citation>
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    <citation>Malek RS, Kuntzman RS, Barrett DM. High power potassium-titanyl-phosphate laser vaporization prostatectomy. J Urol. 2000 Jun;163(6):1730-3.</citation>
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    <citation>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.</citation>
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    <citation>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.</citation>
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    <citation>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.</citation>
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  </reference>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>September 12, 2017</study_first_submitted>
  <study_first_submitted_qc>September 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 29, 2017</study_first_posted>
  <last_update_submitted>October 19, 2022</last_update_submitted>
  <last_update_submitted_qc>October 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Clinique Pasteur</investigator_affiliation>
    <investigator_full_name>Dr Vincent Misrai</investigator_full_name>
    <investigator_title>Investigator coordinator</investigator_title>
  </responsible_party>
  <keyword>Photovaporization</keyword>
  <keyword>Laser</keyword>
  <keyword>Benign prostatic hyperplasia</keyword>
  <keyword>Oral anticoagulation</keyword>
  <keyword>Complication</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Hyperplasia</mesh_term>
    <mesh_term>Hyperplasia</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03297281
org study id: 2017-A01236-47
nct id: NCT03297281
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: 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)
measure: 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
time frame: At 1 month, 3 months and 6 months
description: Haemorrhagic complications are defined by hematuria, bladder clotting removed from patient bed or operating room.
measure: 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
time frame: At 1 month, 3 months and 6 months
description: Thrombotic complications are defined by stroke, transient ischemic attacks and systemic embolisms.
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
arm group label: S1: maintenance
arm group type: Experimental
description: Maintenance of OAC in surgery of BPH by PVP.
arm group label: S2 : discontinuation
arm group type: Active Comparator
description: Discontinuation of OAC in surgery of BPH by PVP.
intervention type: Other
intervention name: Maintenance of OAC in surgery of BPH by PVP.
description: The maintenance of AVK or DOACs treatment in the perioperative setting (without interruption of oral treatment).
arm group label: S1: maintenance
intervention type: Other
intervention name: Discontinuation of OAC in surgery of BPH by PVP.
description: The discontinuation of AVK or DOACs treatment with perioperative heparin relay during postoperative course.
arm group label: S2 : discontinuation
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Vincent Misrai, Dr
role: Principal Investigator
affiliation: Clinique Pasteur
last name: Vincent Misraï, Dr
phone: 05 62 21 33 26
email: vmisrai@clinique-pasteur.com
facility: 
status: Recruiting
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country: France
url: http://sfar.org/wp-content/uploads/2015/09/Reactualisation-GIHP_AOD_actes-programmes_Septembre-20151.pdf
description: Access the 06/03/2017.
url: http://www.jle.com/fr/revues/stv/e-docs/les_essais_de_non_inferiorite_292550/article.phtml
description: Caroline Elie, Emmanuel Touze, Non-inferiority tests, Blood thrombosis vessels 24(2), pp.93-9, 2012.
url: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003658.pdf
description: Access the 06/03/2017.
url: https://www.has-sante.fr/portail/upload/docs/application/pdf/2008-09/surdosage_en_avk_situations_a_risque_et_accidents_hemorragiques_-_synthese_des_recommandations_v2.pdf
description: 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.
citation: 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.
PMID: 16406915
citation: 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.
PMID: 14644114
citation: 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.
PMID: 26283011
citation: 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.
PMID: 23352299
citation: 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.
PMID: 25605646
citation: 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.
PMID: 16945475
citation: 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.
PMID: 15592063
citation: 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.
PMID: 26970929
citation: 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.
PMID: 26095867
citation: 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.
PMID: 25613154
citation: Malek RS, Kuntzman RS, Barrett DM. High power potassium-titanyl-phosphate laser vaporization prostatectomy. J Urol. 2000 Jun;163(6):1730-3.
PMID: 10799170
citation: 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.
PMID: 19638912
citation: 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.
PMID: 24331152
citation: 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.
PMID: 25168547
responsible party type: Sponsor-Investigator
investigator affiliation: Clinique Pasteur
investigator full name: Dr Vincent Misrai
investigator title: Investigator coordinator
mesh term: Prostatic Hyperplasia
mesh term: Hyperplasia