Division of Sexual and Reproductive Medicine, Department of Urology, University of Michigan, Ann Arbor, MI, USA.
J Sex Med. 2012 Sep;9(9):2467-74. doi: 10.1111/j.1743-6109.2012.02819.x. Epub 2012 Jul 3.
A single-armed, prospective, multicenter international study evaluated the redesigned Coloplast Titan One Touch Release (OTR) pump inflatable penile prosthesis. The OTR pump has a unique release valve that permits deflation of the implant with one squeeze of opposing touch pads.
To assess the impact of a new penile prosthesis design, the Titan OTR, on patient ease of operation. Furthermore, to assess patient satisfaction, surgeon acceptance, and the ease with which patients were trained in device operation in the clinic setting.
A total of 113 eligible patients from eight centers were recruited from men presenting with erectile dysfunction without prior prosthetic implantation. The subjects had a mean age of 61 years, and had a number of comorbidities, including diabetes (31.9%), hypertension (34.5%), and Peyronie's disease (23.9%). All underwent implantation of the study device.
Questionnaires were used to capture patient satisfaction as well as physician feedback on ease of implantation and patient education. A paired analysis was completed for patient satisfaction at 6 (N = 96) and 12 (N = 90) months.
Overall satisfaction with the device was 90.6% and 90.0% at 6 and 12 months, respectively. The primary end point, ease of deflation, was seen in 70.8% and 73.3% at these two time points, with the 12-month value statistically better than historical controls. Physicians overwhelmingly reported straightforward/simple intraoperative product preparation (97.3%) and equivalent or easier training compared with their previous pump of choice (96.4%). Adverse events for all subjects (N = 113) included removal of the device in four cases (3.5%) for infection and one case for chronic pain (0.8%).
The Titan OTR represents an advance in penile prosthetic technology that is well accepted by patients and physicians. The study design allowed for realistic evaluation of the new technology aimed at enhancing clinical outcomes.
一项单臂、前瞻性、多中心国际研究评估了重新设计的科洛特 Titan One Touch Release（OTR）泵可膨胀阴茎假体。OTR 泵具有独特的释放阀，只需挤压一对触摸垫即可使植入物放气。
评估新型阴茎假体设计 Titan OTR 对患者操作便利性的影响。此外，评估患者满意度、外科医生接受程度以及患者在临床环境中接受设备操作培训的容易程度。
从 8 个中心招募了 113 名符合条件的男性患者，这些患者因勃起功能障碍就诊且无先前的假体植入。受试者的平均年龄为 61 岁，患有多种合并症，包括糖尿病（31.9%）、高血压（34.5%）和 Peyronie 病（23.9%）。所有患者均植入研究设备。
使用问卷捕获患者满意度以及医生对植入物容易程度和患者教育的反馈。对 6 个月（N = 96）和 12 个月（N = 90）时的患者满意度进行配对分析。
6 个月和 12 个月时，对设备的总体满意度分别为 90.6%和 90.0%。主要终点，即易于放气，在这两个时间点的分别为 70.8%和 73.3%，12 个月时的数值明显优于历史对照。医生几乎一致报告术中产品准备简单/简单（97.3%），与他们之前选择的泵相比，培训同样容易或更容易（96.4%）。所有受试者（N = 113）的不良事件包括 4 例（3.5%）因感染和 1 例（0.8%）因慢性疼痛而取出设备。
Titan OTR 代表了阴茎假体技术的一项进步，患者和医生都能很好地接受。该研究设计允许对旨在提高临床结果的新技术进行现实评估。
