Service d'urologie, CHU de Clermont-Ferrand, 63000 Clermont-Ferrand, France.
Service d'urologie, Hôpital Lyon Sud, Hospices civils de Lyon, 69310 Pierre-Bénite, France.
Prog Urol. 2022 Sep;32(10):717-725. doi: 10.1016/j.purol.2022.04.012. Epub 2022 Jun 4.
Urological emergencies represent 7% of admissions, 29% of which are acute urine retention. We report the first results of a protocol evaluating a new device in case of failure of self-catheterization, replacing a permanent catheter: the urethral device EXIME®.
Intention-to-treat study on the feasibility of inserting the EXIME® prosthesis in a day hospital after simple urethral gel instillation in men with urine retention. EXIME® was proposed to all patients after failure of Foley catheter removal and refusal or inability to learn self-catheterization. The protocol was referenced (NCT04218942) after obtaining the agreement of the committee for the protection of individuals.
Among 278 patients admitted for a trial of Foley catheter removal, 15 patients with failed voiding resumption and refusal or failure of self-catheterization were offered the prosthesis. The median age was 73 years with a median retention volume of 700mL. The median prostatic volume was 60g. Fourteen patients had their prosthesis inserted in good conditions of comfort for the practitioner and the patient. One failed placement was noted. The difficulty of insertion was estimated by the practitioner at 0 on median (VAS from 0 to 10), and for its removal at 0. The pain during the insertion of the device was evaluated by the patients at 2.00 and for the removal at 0 (VAS from 0 to 10). 6 patients had satisfactory voiding recovery at D0.
We proposed the placement of EXIME to patients who had failed the trial of Foley removal and were unable and/or unwilling to self-catheterize. These were patients with poor bladder contractility and a high risk of retention recurrence. Despite this mixed result, the simplicity of the device and the comfortable expectation of an endoscopic procedure seem promising.
Insertion and retrieval of EXIME®prostatic prosthesis were easy and well tolerated in our population. Insertion failed in one patient. A comparative prospective study with self catheterization is necessary to determine its effectiveness.
泌尿科急症占住院患者的 7%,其中 29%为急性尿潴留。我们报告了一种新设备的协议评估结果,该设备在 Foley 导管拔除失败后,可替代永久性导管,用于治疗尿潴留患者:EXIME®尿道装置。
这是一项在男性尿潴留患者行简单尿道凝胶滴注后,于日间病房内尝试插入 EXIME®假体的意向治疗研究。在 Foley 导管拔除失败且拒绝或无法进行自我导尿的患者中,均提出使用 EXIME®。在获得保护个人委员会的同意后,该方案被注册(NCT04218942)。
在 278 例因 Foley 导管拔除试验而入院的患者中,有 15 例因排尿恢复失败且拒绝或无法进行自我导尿而接受了该假体。中位年龄为 73 岁,中位潴留量为 700ml。前列腺体积的中位数为 60g。14 例患者在操作医生和患者都感到舒适的情况下成功插入假体。有 1 例插入失败。操作医生估计插入的难度为 0 (VAS 为 0 到 10),取出的难度为 0。患者评估插入装置时的疼痛为 2.00,取出时的疼痛为 0 (VAS 为 0 到 10)。在 D0 时有 6 例患者排尿恢复令人满意。
我们将 EXIME 假体置入那些 Foley 导管拔除试验失败且无法和/或不愿自我导尿的患者。这些患者的膀胱收缩力较差,且有很高的再潴留风险。尽管结果喜忧参半,但该设备的简单性和预期的内镜操作舒适性似乎很有前景。
EXIME®前列腺假体在我们的人群中易于插入和取出,且耐受性良好。在一名患者中插入失败。为了确定其有效性,需要进行一项与自我导尿的前瞻性比较研究。