The model AMS800 artificial urinary sphincter was implanted in 117 patients with urinary incontinence resulting from radical prostatectomy. The indication for implantation was total incontinence in 107 patients and stress incontinence in 10. All patients had bulbous urethral cuff insertion and 20 had previous pelvic irradiation. Followup questionnaire indicated a 90% significantly improved continence rate and a 90% satisfaction rate among patients. There were 64 surgical revisions required in 37 patients: inadequate cuff compression in 21 (33%), tubing kinks in 10 (16%), urethral cuff erosion in 8 (13%), scrotal hematoma in 6 (9%), control assembly malfunction in 4 (6%) and cuff leaks in 4 (6%). Of the 20 patients with previous pelvic radiation 2 (10%) had at least 1 erosion, compared to 5 of 97 (5%) in the nonirradiated group. At followup 5 patients did not have at least 1 component of the AMS800 device indwelling (2 cuffs and 3 entire devices had been removed).

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The American Medical Systems inflatable penile prosthesis has undergone periodic design changes to improve device reliability and longevity while maintaining a high degree of patient and partner satisfaction. Previous data reported from this institution did not consider these frequent design changes and the assessment of device reliability incorporated consecutive cases involving several different designs. This study was designed to evaluate followup data on 120 patients who received the model 700 inflatable penile prosthesis, permitting assessment of device reliability of a single design. Two groups were evaluated: a pre-fix group of 57 patients and a post-fix group of 63 patients. Over-all, 11.7 per cent of the total group required revision (21 per cent of the pre-fix and 3.2 per cent of the post-fix groups). Careful life-table analysis of the results with the current model 700 device (post-fix) reveals that this model has a 97 per cent chance of maintaining normal mechanical function for 3 years. Further assessment of these patients in the future will provide additional data on long-term reliability of this design.

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