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- W4250707339 abstract "Abstract Background Though transurethral resection of the prostate is still considered to be the ‘‘gold standard’’ procedure for benign prostatic obstruction (BPO), the reported post-operative complication rate is not uncommon. The emerging of minimally invasive focal ablative therapies provide an alternative option for patients who are dissatisfied with medical treatment yet do not willing to take the interventional procedures. Irreversible electroporation (IRE) is a novel focal therapy which can accurately ablate the target tissues with minimum damage to the surrounding structures. The application of IRE in selected patients with prostate cancer has yielded promising results, but no report on BPO has been published. Methods/design This is a single-centered, prospective, randomized controlled trial to evaluate the effectiveness and safety of IRE in treating BPO compare with tamsulosin. We aim to recruit BPO patients who are currently taking tamsulosin but without absolute indications for surgical intervention. Eligible subjects will undergo a 3-day treatment free washout period, followed by baseline assessment. After randomized into IRE group and tamsulosin (0.2mg orally once daily) group, subjects will be followed-up for up to 24 months. The primary clinical outcome is the change in maximum flow rate from baseline at 6 months. Other assessments, including symptom questionnaires, ultrasound, prostatic specific antigen, prostate magnetic resonance image and pressure-flow study, will be carried out at different time points during follow-up. Any perception or patient-reported adverse events in both treatment arms will be documented. Data will be analyzed by a specialist who is blinded to the medical status and treatment modality in order to minimize the potential bias. Discussion This is the first randomized controlled trial evaluating the feasibility of IRE for the treatment of BPO. The outcomes of this study will provide high level of evidence to determine its true clinical value." @default.
- W4250707339 created "2022-05-12" @default.
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- W4250707339 date "2019-09-19" @default.
- W4250707339 modified "2023-09-30" @default.
- W4250707339 title "The safety and efficacy of irreversible electroporation versus tamsulosin in the treatment of benign prostatic obstruction: study protocol and rationale for a randomized controlled trial" @default.
- W4250707339 doi "https://doi.org/10.21203/rs.2.14639/v1" @default.
- W4250707339 hasPublicationYear "2019" @default.
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