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Benign Prostatic HyperplasiaSOAPNCT03297281

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

A study testing Maintenance of OAC in surgery of BPH by PVP. and Discontinuation of OAC in surgery of BPH by PVP. in people with Benign Prostatic Hyperplasia and Anticoagulant Adverse Reaction, run by Clinique Pasteur at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Maintenance of OAC in surgery of BPH by PVP. and Discontinuation of OAC in surgery of BPH by PVP.
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
389 participants
Where
1 siteFrance
Study dates
30 Oct 2017to 31 May 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 18Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Vincent Misraï, Dr contact

05 62 21 33 26

vmisrai@clinique-pasteur.com

France1 site, 1 recruiting

  • Clinique Pasteur

    Toulouse, 31 076

    Vincent Misraï, Dr, 05 62 21 33 26, vmisrai@clinique-pasteur.com

    Nicolas Barry Delongchamps, Dr

    Recruiting

Other trials in France

About this study

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

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.

Read more

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.

Read the 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.

Being tested
Maintenance of OAC in surgery of BPH by PVP., Discontinuation of OAC in surgery of BPH by PVP.
Keywords
Photovaporization, Laser, Benign prostatic hyperplasia, Oral anticoagulation, Complication
Medical subject headings
Prostatic Hyperplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Maintenance of OAC in surgery of BPH by PVP.Other

    The maintenance of AVK or DOACs treatment in the perioperative setting (without interruption of oral treatment).

  • Discontinuation of OAC in surgery of BPH by PVP.Other

    The discontinuation of AVK or DOACs treatment with perioperative heparin relay during postoperative course.

Study groups in NCT03297281
Study groupRoleWhat they receive
S1: maintenanceExperimentalMaintenance of OAC in surgery of BPH by PVP.
Receives: Other: Maintenance of OAC in surgery of BPH by PVP.
S2 : discontinuationActive comparatorDiscontinuation of OAC in surgery of BPH by PVP.
Receives: Other: Discontinuation of OAC in surgery of BPH by PVP.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Between day 0 (day of the surgery) and day 30 (1 month after surgery)

Secondary outcomes (8)

  1. 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.

    Measured: At 1 month, 3 months and 6 months

  2. 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.

    Measured: At 1 month, 3 months and 6 months

  3. Duration of hospitalization related to perioperative management of anticoagulants will be measured at the patient's discharge

    Measured: At the patient's discharge, on average 3 days after surgery

  4. Prostatic residual volume will be measured to evaluate the quality of resection under oral-anticoagulant at 1 month, 3 months, and 6 months

    Measured: At 1 month, 3 months and 6 months

  5. PSA level will be measured to evaluate the quality of resection under oral-anticoagulant at 1 month, 3 months, and 6 months

    Measured: At 1 month, 3 months and 6 months

  6. 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

    Measured: At 1 month, 3 months and 6 months

  7. 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

    Measured: At 1 month, 3 months and 6 months

  8. 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

    Measured: At 1 month, 3 months and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2017
  2. Study start30 Oct 2017
  3. Primary completion30 Nov 2027 (estimated)
  4. Study completion31 May 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
389 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03297281
Sponsor's protocol ID
2017-A01236-47
Acronym
SOAP
Status last verified
Mar 2026
First submitted
12 Sep 2017
Last updated
6 Mar 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 16406915

  • 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.

    PubMed 14644114

  • 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.

    PubMed 26283011

  • 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.

    PubMed 23352299

  • 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.

    PubMed 25605646

  • 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.

    PubMed 16945475

  • 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.

    PubMed 15592063

  • 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.

    PubMed 26970929

  • 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.

    PubMed 26095867

  • 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.

    PubMed 25613154

  • Malek RS, Kuntzman RS, Barrett DM. High power potassium-titanyl-phosphate laser vaporization prostatectomy. J Urol. 2000 Jun;163(6):1730-3.

    PubMed 10799170

  • 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.

    PubMed 19638912

  • 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.

    PubMed 24331152

  • 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.

    PubMed 25168547

  • 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.

    PubMed 30587221

Questions about this trial

What is this clinical trial studying?

A study testing Maintenance of OAC in surgery of BPH by PVP. and Discontinuation of OAC in surgery of BPH by PVP. in people with Benign Prostatic Hyperplasia and Anticoagulant Adverse Reaction, run by Clinique Pasteur at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Vincent Misraï, Dr (05 62 21 33 26, vmisrai@clinique-pasteur.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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 (time frame: Between day 0 (day of the surgery) and day 30 (1 month after surgery)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03297281, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.

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