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美国医疗系统新型触觉泵的早期使用经验:一项多中心研究的结果

Early experience with the American Medical Systems new tactile pump: results of a multicenter study.

作者信息

Delk John, Knoll L Dean, McMurray James, Shore Neal, Wilson Steven

机构信息

Institute for Urologic Excellence, Department of Urology, University of Arkansas for Medical Science, Little Rock, Arkansas, USA.

出版信息

J Sex Med. 2005 Mar;2(2):266-71. doi: 10.1111/j.1743-6109.2005.20238.x.

DOI:10.1111/j.1743-6109.2005.20238.x
PMID:16422896
Abstract

INTRODUCTION

A new Tactile Pump for the American Medical Systems (AMS) 700 Inflatable Penile Prosthesis (IPP) had been developed in an effort to improve usability for the patient. Aim. To assess the ease of use of the new Tactile Pump.

METHODS

A prospective, multicenter study was conducted at four investigative sites. Preoperatively, patients completed an evaluation of the new Tactile Pump vs. the current design 700 pump placed in scrotal models. Patients compared the ease of inflation and deflation of each model. All patients were implanted with the AMS 700 IPP including the new Tactile Pump. Patients returned at 6 weeks for activation of the device and for follow-up evaluation at 3 and 6 months.

MAIN OUTCOME MEASURES

Preoperatively patients compared ease of use of the Tactile Pump vs. the current design. Postoperatively both physicians and patients assessed device functionality for inflation and deflation, ease of use of the pump, and time required to learn device operation.

RESULTS

Thirty patients were implanted with the AMS 700 IPP and Tactile Pump. Thirty patients completed an activation visit, 20 patients completed the 3-month evaluation, and 9 patients completed the 6-month evaluation. The average age was 62.1 years. Primary erectile dysfunction etiologies included organic, nonspecific 10 (33.3%), vasculogenic 6 (20.0%), prostatectomy 6 (20.0%), diabetes mellitus 4 (13.3%), Peyronie's disease 3 (10.0%), and spinal cord injury 1 (3.3%). Preoperatively 93.3% (P < 0.001) of patients favored the Tactile Pump over the current pump on locating and working the inflation mechanism in the scrotal model. Patients also found the Tactile Pump deflation mechanism easier to find 100% (P < 0.001) and deflate 96.7% (P < 0.001). Most patients (86.7%) were trained to use their devices within 3 minutes.

CONCLUSIONS

The AMS Tactile Pump provides benefit to patients and physicians by improving ease of use and training over the current IPP 700 pump.

摘要

引言

为了提高患者的使用便利性,已开发出一种用于美国美敦力公司(AMS)700型可膨胀阴茎假体(IPP)的新型触觉泵。目的:评估新型触觉泵的易用性。

方法

在四个研究地点进行了一项前瞻性多中心研究。术前,患者对新型触觉泵与置于阴囊模型中的当前设计700泵进行了评估。患者比较了每个模型的充气和放气的难易程度。所有患者均植入了包括新型触觉泵在内的AMS 700 IPP。患者在6周后返回进行设备激活,并在3个月和6个月时进行随访评估。

主要观察指标

术前患者比较了触觉泵与当前设计的易用性。术后,医生和患者都评估了设备充气和放气的功能、泵的易用性以及学习设备操作所需的时间。

结果

30名患者植入了AMS 700 IPP和触觉泵。30名患者完成了激活访视,20名患者完成了3个月评估,9名患者完成了6个月评估。平均年龄为62.1岁。原发性勃起功能障碍的病因包括器质性、非特异性10例(33.3%)、血管源性6例(20.0%)、前列腺切除术6例(20.0%)、糖尿病4例(13.3%)、佩罗尼氏病3例(10.0%)和脊髓损伤1例(3.3%)。术前,93.3%(P<0.001)的患者在阴囊模型中定位和操作充气机制时更喜欢触觉泵而不是当前的泵。患者还发现触觉泵放气机制更容易找到,占100%(P<0.001),放气更容易,占96.7%(P<0.001)。大多数患者(86.7%)在3分钟内学会了使用他们的设备。

结论

与当前的IPP 700泵相比,AMS触觉泵通过提高易用性和培训效果,为患者和医生带来了益处。

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