Patient satisfaction study for the new Rigicon Infla10 inflatable penile prosthesis including single surgeon safety and outcomes data.

IF 3.3 3区医学 Q1 UROLOGY & NEPHROLOGY

Journal of Sexual Medicine Pub Date : 2025-01-09 DOI:10.1093/jsxmed/qdae168

Naci Burak Cinar, Ali Saribacak, Britney L Atwater, Martin S Gross, Steven K Wilson, Melih Culha

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引用次数: 0

Abstract

Background: Rigicon is a newer inflatable penile prostheses (IPP) manufacturer that has produced the Infla10 IPP for countries outside the United States (US) since 2019, with Food and Drug Administration studies for approval of Infla10 in the US presently underway.

Aim: This study aims to report the first patient satisfaction, efficacy, and safety from revision data for the newly available Rigicon Infla10 IPP.

Methods: A single surgeon's first 58 patients who underwent Rigicon Infla10 IPP implantation between 2019 and 2023 were included. Most patients (70%) received the Infla10 X (girth expansion) cylinder, and 30% received the Infla10 AX (length and girth expansion) model. Follow-up ranged from 4 to 42 months (median 19 months).

Outcomes: Outcomes measured were intraoperative and postoperative complications as well as patient-reported satisfaction.

Results: Reoperation was required in 5 patients (8.6%). Complication rates were 1.7% urethral erosion (n = 1), 1.7% infection requiring explant (n = 1), and 5% mechanical malfunction due to tubing breakage at pump junction (n = 3). The tubing issue was addressed by the manufacturer, resulting in no additional mechanical concerns. Kaplan-Meier analysis demonstrated rates of cumulative survival of the device at 12, 24, and 36 months were 96.6%, 93.8%, and 78.2%, respectively. Overall, 53 patients (91.4%) were satisfied at 6 months postoperatively and would recommend the procedure. Diminished satisfaction was due to perceived penile shortening in 3 patients (5.1%) and difficulty learning pump cycling in 2 patients (3.4%).

Clinical implications: This single surgeon series demonstrates high rates of patient satisfaction with appropriate early safety from revision.

Strengths and limitations: Limitations include the retrospective nature of this study and short-term follow-up. Additional prospective studies incorporating a larger number of patients are warranted.

Conclusion: While very new in the marketplace, the Infla10 IPP shows promising early satisfaction, efficacy, and safety from revision.

查看原文本刊更多论文

Rigicon新型充气阴茎假体的患者满意度研究，包括单个外科医生的安全性和结果数据。

背景：Rigicon是一家较新的充气阴茎假体（IPP）制造商，自2019年以来为美国以外的国家生产了Infla10 IPP，目前正在进行美国食品和药物管理局批准Infla10的研究。目的：本研究旨在报告新上市的Rigicon Infla10 IPP的首次患者满意度、疗效和安全性。方法：纳入一位外科医生在2019年至2023年期间接受Rigicon Infla10 IPP植入的前58例患者。大多数患者（70%）接受了Infla10 X（周长扩张）圆柱体，30%接受了Infla10 AX（长度和周长扩张）模型。随访时间为4 ~ 42个月（中位19个月）。结果：测量术中和术后并发症以及患者报告的满意度。结果：需再手术5例（8.6%）。并发症发生率为1.7%尿道糜烂（n = 1）， 1.7%感染需要外植体（n = 1）， 5%因泵连接处管道断裂而机械故障（n = 3）。油管问题已由制造商解决，没有产生额外的机械问题。Kaplan-Meier分析显示，该装置在12、24和36个月的累积生存率分别为96.6%、93.8%和78.2%。总体而言，53例患者（91.4%）在术后6个月满意并推荐该手术。满意度降低的原因是3例（5.1%）患者感觉阴茎缩短，2例（3.4%）患者学习泵循环困难。临床意义：这个单一的外科医生系列显示了高的患者满意度和适当的早期安全翻修。优势和局限性：局限性包括本研究的回顾性和短期随访。纳入更多患者的其他前瞻性研究是有必要的。结论：虽然在市场上很新，但Infla10 IPP显示出有希望的早期满意度、疗效和安全性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Sexual Medicine 医学-泌尿学与肾脏学

CiteScore

6.20

自引率

5.70%

发文量

826

审稿时长

2-4 weeks

期刊介绍： The Journal of Sexual Medicine publishes multidisciplinary basic science and clinical research to define and understand the scientific basis of male, female, and couples sexual function and dysfunction. As an official journal of the International Society for Sexual Medicine and the International Society for the Study of Women''s Sexual Health, it provides healthcare professionals in sexual medicine with essential educational content and promotes the exchange of scientific information generated from experimental and clinical research. The Journal of Sexual Medicine includes basic science and clinical research studies in the psychologic and biologic aspects of male, female, and couples sexual function and dysfunction, and highlights new observations and research, results with innovative treatments and all other topics relevant to clinical sexual medicine. The objective of The Journal of Sexual Medicine is to serve as an interdisciplinary forum to integrate the exchange among disciplines concerned with the whole field of human sexuality. The journal accomplishes this objective by publishing original articles, as well as other scientific and educational documents that support the mission of the International Society for Sexual Medicine.