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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.

ABSTRACT: BACKGROUND:Lower urinary tract symptoms related to benign prostatic obstruction (BPO) are frequent in men aged >?50?years. Based on the use of innovative medical devices, a number of transurethral ablative techniques have recently been developed for the surgical treatment of BPO. In recent years, GreenLight photoselective vaporization of the prostate (PVP) has been considered as a non-inferior alternative to transurethral resection of the prostate. The GreenLight PVP is usually considered as an interesting surgical option for patients treated via oral anticoagulants (OACs) with regard to its haemostatic properties. The aim of this study was to assess the impact of maintaining OAC treatment in patients undergoing PVP. METHODS:This study is a multicentre, open-label, randomized controlled trial (RCT) designed to show the non-inferiority of PVP surgery in patients with BPO treated with OACs. This study is designed to enrol 386 OAC-treated patients (treated with vitamin K antagonists and direct oral anticoagulants) who are undergoing PVP for BPO. Patients will be randomized (1:1) to either maintain or stop OAC treatment during the perioperative course. The intervention group will maintain OAC treatment until the day before surgery and resume OAC treatment the day after surgery, whereas the control group will stop OAC treatment (with or without low-molecular-weight heparin bridging therapy) according to the anaesthesia guidelines. The primary outcome of interest to be assessed is the 30-day complications rate according to the Clavien-Dindo classification. The secondary endpoint will examine the 30-day rate of haemorrhagic and thrombotic events. This study will provide 80% power to show non-inferiority, defined as not worse than a 10% (non-inferiority margin) inferior change in the proportion of patients with good outcomes (Clavien-Dindo score?

SUBMITTER: Charbonneau H

PROVIDER: S-EPMC6307178 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature

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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.

Charbonneau Hélène H Pasquié Marie M Peyronnet Benoit B Descazeaud Aurélien A Barry-Delongchamps Nicolas N Della Negra Emmanuel E Mathieu Romain R Karsenty Gilles G Karsenty Gilles G Long Jean-Alexandre JA Ballereau Charles C Azzouzi Abdel-Rahmène AR Pradère Benjamin B Bruyère Franck F Fournier Georges G Lebdai Souhil S Calves Jehanne J Corbel Luc L Vincendeau Sébastien S Fiard Gaelle G Thuillier Caroline C Descotes Jean-Luc JL Colin Pierre P Culty Thibaut T Hesbois Audrey A Fuzier Valerie V Savy Nicolas N Pathak Atul A Albaladejo Pierre P Samama Charles Marc CM Guerrero Felipe F Misraï Vincent V

Trials 20181227 1

<h4>Background</h4>Lower urinary tract symptoms related to benign prostatic obstruction (BPO) are frequent in men aged > 50 years. Based on the use of innovative medical devices, a number of transurethral ablative techniques have recently been developed for the surgical treatment of BPO. In recent years, GreenLight photoselective vaporization of the prostate (PVP) has been considered as a non-inferior alternative to transurethral resection of the prostate. The GreenLight PVP is usually considere ...[more]

PMID: 30587221

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Project description:BackgroundAs an alternative to transurethral resection of the prostate (TURP), photoselective vaporization of the prostate (PVP) provides a bloodless, relatively painless relief of lower urinary tract symptoms for men with benign prostatic hyperplasia. Following a review of the evidence in 2006, the Ontario Health Technology Advisory Committee recommended that a study be conducted to evaluate PVP in Ontario.ObjectivesTo compare the clinical effectiveness, safety, cost-effectiveness, and budget impact of PVP compared to conventional TURP for the treatment of benign prostatic hyperplasia in Ontario.MethodsA prospective, nonrandomized trial was conducted in 3 Ontario centres. Consenting subjects were assessed at baseline and 1, 3, and 6 months following surgery. Outcome measures included International Prostate Symptom Score (IPSS), peak urinary flow rate (Qmax), post-void residual (PVR) volume, prostate-specific antigen (PSA), health-related quality of life (HRQOL) using the EuroQol 5 Domain questionnaire, and the Sexual Health Inventory for Men (SHIM) score. Adverse events, resource utilization, and productivity losses were also assessed. Cost-effectiveness and budget impact analyses were completed using data from the study.ResultsBetween February 2008 and August 2010, 164 subjects were enrolled in the study (n = 140 for PVP and n = 24 for TURP). Treatment outcomes were similar between the 2 groups at 6 months, with the IPSS decreasing similarly over time (P = 0.718). For other treatment outcomes (Qmax, PSA, HRQOL, SHIM) both treatments provided similar benefit over time; only changes in PVR volume favoured PVP (P = 0.018). The majority of PVP patients were managed on an outpatient basis, with only 7.1% requiring admission (all TURP subjects were inpatients). At 6 months, PVP was less costly than TURP ($3,891 versus $4,863; P = 0.001), with similar quality-adjusted life-years (0.448 versus 0.441; P = 0.658). PVP remained the most cost-effective treatment across all decision-making thresholds, with the technology costing less and providing similar clinical outcomes. Extrapolating the results to a provincial level indicated (based on an estimated case volume of 12,335 TURPs) that there is an opportunity to reallocate just over $14 million (Cdn), primarily related to the reduced need for hospital admission.LimitationsThis study was nonrandomized, and the results should be interpreted with some caution, despite generally similar baseline characteristics between the 2 groups. Recruiting individuals to the TURP arm was a challenge, resulting in a size imbalance between treatment arms.ConclusionsBased on this analysis, PVP appears to be a cost-effective alternative to TURP, providing similar clinical benefit at a lower cost to the health system.

Project description:BackgroundTo investigate the efficacy and safety of a second-generation bipolar transurethral electro vaporization of the prostate (B-TUVP) with the new oval-shaped electrode for large benign prostatic enlargement (BPE) with prostate volume (PV) ≥100ml.Materials and methods100 patients who underwent second-generation B-TUVP with the oval-shaped electrode for male lower urinary tract symptom (LUTS) or urinary retention between July 2018 and July 2020 were enrolled in this study. The patients' characteristics and treatment outcome were retrospectively compared between patients with PV <100ml and ≥100ml.Results17/41 (41.5%) cases of PV ≥100ml and 24/59 cases (40.7%) of PV <100ml were catheterised due to urinary retention. The duration of post-operative catheter placement and hospital-stay of PV ≥100ml (3.1±1.3 and 5.6±2.3 days) were not different from PV <100ml (2.7±1.2 and 5.0±2.4 days). In uncatheterised patients (N = 59), post-void residual urine volume (PVR) significantly decreased after surgery in both groups, however, maximum uroflow rate (Qmax) significantly increased after surgery only in PV <100ml but not in PV ≥100ml. Voiding symptoms and patients' QoL derived from International Prostate Symptom Score (IPSS), IPSS-QoL (IPSS Quality of Life Index) and BPH Impact Index (BII) scores, significantly improved after B-TUVP in both groups. Catheter free status after final B-TUVP among patients with preoperative urinary retention was achieved in 18/24 (75.0%) and 14/17 (82.1%) cases in patient with <100ml and ≥100ml, respectively. There was no significant difference in post-operative Hb after B-TUVP, which was 97.0±5.4% of baseline for PV <100ml and 96.9±6.1% for PV ≥100ml and no TUR syndrome was observed.ConclusionsThis is the first study investigating short-term efficacy and safety of second-generation B-TUVP with the oval-shaped electrode on large BPE. B-TUVP appears to be effective and safe for treating moderate-to-severe lower urinary tract symptoms and urinary retention in patients with large BPE.

Dataset Information

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.

Publications

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.

Similar Datasets

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