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Clinical Trial
. 2005 Mar;2(2):266-71.
doi: 10.1111/j.1743-6109.2005.20238.x.

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

John Delk  1 , L Dean Knoll, James McMurray, Neal Shore, Steven Wilson
Affiliations
Clinical Trial

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

John Delk et al. J Sex Med. 2005 Mar.

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.

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