The model AS 800 artificial urinary sphincter: Mayo Clinic experience

The model AS 800 artificial urinary sphincter was implanted in 100 male and 9 female patients between 7 and 89 years old. Postoperative followup was 1 to 32 months. The indication for implantation was total urinary incontinence in 86 patients (78.9 per cent), stress incontinence in 22 (21.2 per cent) and urgency incontinence in 1 (0.9 per cent). Of the patients 97 (89 per cent) underwent implantation for the first time, 7 (6.4 per cent) had a previous artificial urinary sphincter model replaced by the AS 800 device and 5 (4.6 per cent) underwent reimplantation of a previous model. The cuff was placed around the bladder neck in all 9 female patients, whereas in the male patients the cuff was implanted around the bladder neck in 20 and around the bulbous urethra in 80. Thirty-one patients (28.4 per cent), 29 of whom were continent at night, were practicing nocturnal deactivation of the device. Complete post-activation continence was achieved in 91 patients (83.5 per cent), some leakage occurred in 10 (9.2 per cent) and 8 (7.3 per cent) remained incontinent. A total of 23 patients required 1 or more revisions, the most common indications for the first revision being loss of cuff compression (9), tubing kink (3), cuff erosion (3) and infection (2). At the time of this report 89 patients (81.7 per cent) were continent, 9 (8.3 per cent) still had some leakage, 3 (2.8 per cent) were incontinent, 5 (4.6 per cent) were awaiting reimplantation and 3 (2.8 per cent) had died of unrelated causes.     

Experience with the artificial urinary sphincter model AS800 in 148 patients

The latest version of the artificial urinary sphincter, AS800, was used in 148 patients with urinary incontinence of different etiologies. Followup ranged from 3 to 37 months, with an average of 20.8 months. There were 112 (76 per cent) male and 36 (24 per cent) female patients. The cuff was implanted around the bladder neck in 78 patients (53 per cent) and around the bulbar urethra in 70 (47 per cent). Socially acceptable urinary control was achieved in 90 per cent of the 139 patients with active devices in place. It was necessary to remove the sphincter in 11 patients (7.4 per cent). The reasons for removal were infection and erosion in 8 patients (5.4 per cent), infection without erosion in 2 (1.3 per cent), and erosion due to excess pressure and poor tissues in 1 (0.7 per cent). Comparison of success and failure rates associated with incontinence of different etiologies revealed that patients with incontinence after failure of a conventional antistress incontinence operation and those with incontinence after transurethral resection or radical prostactectomy had the highest success rate, and that patients with incontinence secondary to pelvic fracture or exstrophy and epispadias had the highest failure rates. The deactivation feature (the lock) of the new artificial sphincter model was beneficial for primary deactivation, urethral catheterization or cystoscopy, or for elective nocturnal decompression of the bladder neck or urethral tissues.     

The AS 800 artificial urinary sphincter in children with myelodysplasia. Preliminary results

Ten children with myelodysplasia and intractable urinary incontinence have been implanted with an AS 800 artificial sphincter. Eight remain dry and 2 are improved over a follow-up period of 12 - 14 months. However, most have shown a reduction in bladder compliance, which suggests that further surgery may be necessary to maintain continence.     

The artificial urinary sphincter in children. Experience with the AS800 series and bowel reconstruction

Recent reports have shown that the artificial urinary sphincter is a reliable means of achieving urinary continence in both adults and children who have urinary incontinence of various etiologies. Although complications may occur, currently the artificial urinary sphincter is the most efficient means of obtaining urinary continence. The author discusses the features of the device, how to trouble-shoot when problems occur, and the role of the device in patients who have undergone partial or total reconstruction of the bladder with bowel.     

The artificial urinary sphincter (AS 800): experience in 166 consecutive patients.

The artificial urinary sphincter model AS 800 was implanted in 166 patients with incontinence of various etiologies. Followup ranged from 6 to 94 months, with a mean of 41.6 months. Patient age ranged from 5 to 84 years, with a mean age of 59.4 years. There were 10 female patients (6%) and 156 male patients (94%). The cuff was implanted around the bladder neck in 27 patients (16%) and around the bulbous urethra in 139 (84%). A total of 40 reoperations (27 revisions and 13 device removals) was performed in 32 of 166 patients (19.3%). There were 13 mechanical device failures (7.8%), 11 cuff erosions (6.6%) and 2 periprosthetic infections (1.2%). Total or near total continence was achieved in 125 patients (75.3%), while 25 (15.1%) had improved urinary control.     

Management of cuff erosion of the double cuff artificial urinary sphincter

PURPOSE: We report on a series of patients with erosion of 1 cuff of an AMS800 double cuff artificial urinary sphincter and determine the success rate of removing the eroded cuff, leaving the other components behind and converting the device to a single cuff system. MATERIALS AND METHODS: In 9 patients with a double cuff artificial sphincter 1 eroded cuff was removed and the system was converted to a single cuff sphincter. RESULTS: Followup was based on an incontinence scoring system. In 1 patient the remaining cuff was removed because it also eroded. In another patient a wound infection developed 5 months after placement and the entire device was removed. The remaining 7 patients had better continence scores than before artificial sphincter placement but each remarked that continence was better with 2 cuffs. CONCLUSIONS: An eroded cuff of a double cuff artificial urinary sphincter system can be successfully removed and the device can be converted to a single cuff system.     

The AS800 artificial sphincter for the treatment of female incontinence

From 1983 to May 1991, the artificial sphincter AS800 has been applied in 106 female patients for the treatment of complicated cases of urinary incontinence. Of these, 80 remained in continuous follow-up and have now been followed up for at least 1 year, with a mean of 3.8 years. In 40 of our female patients the urethra was afunctional secondary to failure of previous anti-stress-incontinence procedures. Neurogenic incontinence with sphincteric involvement affected 30, while 10 of the patients had congenital sphincter anomalies or traumatic sphincter weakness. Following implantation of the artificial sphincter, 86.3% of these patients are completely continent and do not need a pad. With regard to emptying, 81.3% are able to empty their bladder without residual urine after opening the sphincter, and 8 have to perform clean intermittent catheterization (CIC) once or twice daily in addition. A further 7 void exclusively by CIC. As preparation for implantation of the AS800 sphincter, 24 additional procedures were performed, including 5 antireflux operations and 6 bladder-flap procedures. In 38 of 80 patients a total of 62 revisions were performed. Infection and erosion were the most common reasons for revision, accounting for 48.2% of all revisions. The next most common reason was tissue atrophy underneath the cuff. However, 25% of the revisions were due to device failures, most often cuff leakage.     

Experience with the AS-800 artificial urinary sphincter in myelodysplastic children.

The authors describe their experience with an artificial urinary sphincter (model AS-800; American Medical Systems, Minnetonka, Minn.) in treating urinary incontinence in children. Twenty-eight sphincters were implanted in 27 boys between May 1986 and June 1989. All the boys had neurogenic bladders secondary to myelomeningocele or sacral agenesis. The mean age at the time of initial implantation was 14 years (range from 9 to 19 years), and the median follow-up was 12 months (range from 6 to 31 months). The sphincters were implanted initially around the bladder neck in 25 cases. Three required reimplantation around the bulbous urethra. The complication rate was 39% (11 of 28 cases). There were two cases of erosion, two cases of infection without erosion and seven cases of device-related problems. The artificial sphincter had to be removed in four cases. There were no deaths. The revision rate was 25% (7 of 28 cases). Continence was evaluated in 22 (88%) of 25 boys who had functional sphincters in place. Five boys required oxybutinin chloride to maintain continence. Ten boys required augmentation cystoplasty before (3), after (6) and combined with (1) sphincter implantation. Eight of these 10 children were able to void spontaneously and were continent. One required intermittent catheterization twice a day and another six times a day. The authors conclude from their experience that the artificial urinary sphincter (model AS-800) can establish continence in boys with neurogenic bladders. Proper selection of the ideal patient for the artificial sphincter is essential to avoid complications.     

Long-term experience with the double-cuff AMS 800 artificial urinary sphincter

Objectives

To assess the efficacy and safety of the double-cuff artificial urinary sphincter over a long-term period.

Methods

Ninety-five patient charts were reviewed from December 1986 to November 1995. Data on the degree of urinary incontinence and complications were compiled and tabulated.

Results

There were 10 cuff erosions (10.5%) and one infection (1.1 %) requiring removal of the double-cuff system, with one death from unrelated causes. Two patients in the erosion group had a double-cuff system reinserted at a later date. Eighty-six patients have a double-cuff system, with 97.6% remaining dry.

Conclusions

A tandemly placed double-cuff artificial urinary sphincter is safe and effective in the treatment of severe postprostatectomy urinary incontinence.     

The Asia-Pacific AMS800 artificial urinary sphincter consensus statement

This Asia-Pacific (AP) AMS 800™ artificial urinary sphincter (AUS) consensus statement aims to provide a set of practical recommendations to assist surgeons with the AMS 800 device surgery. The AP consensus committee consisted of key opinion leaders with extensive experience with AMS 800 surgery across several AP countries. The panel reviewed and discussed relevant findings with emphasis on locoregional and specific clinical challenges relevant to the AP region. Recommendations were made in key areas namely (1) patient selection and informed consent process; (2) preoperative assessment; (3) dealing with co-existing urological disorders; (4) surgical principles and intraoperative troubleshooting; (5) postoperative care; (6) special populations; and (7) cost analysis and comparative review. The AMS 800 device should be offered to males with moderate to severe stress urinary incontinence (SUI). Full informed consent should be undertaken, and emphasis is placed on surgical contraindications and high-risk candidates. The presence of a surgical mentor or referral to experts is recommended in complex AUS candidates. Preoperative cystoscopy with or without multichannel urodynamic study is necessary and patients with pre-existing urological disorders should be treated adequately and clinically stable before surgery. Adherence to strict patient selection and safe surgical principles are critical to ensure excellent clinical outcomes and minimize complications. Given that InhibiZone-coated device is not available in many AP countries, the use of prophylactic antibiotics pre-and post-operatively are recommended. The AMS 800 device should be prepared according to the manufacturer's guidelines and remains a cost-effective treatment for male SUI. The AMS 800 device remains the surgical benchmark for male SUI but is associated with certain mechanical limitations and a unique set of complications.     

In situ urethroplasty after artificial urinary sphincter cuff erosion

Artificial urinary sphincter (AUS) cuff erosion is a challenging complication traditionally managed with device removal and Foley catheter drainage. Urethral stricture can result secondary to the healing process, delaying AUS reimplantation. In situ urethroplasty (ISU) technique is a definitive repair at the time of device removal. Early results demonstrate a decreased rate of stricture formation compared to traditional management with little additional operative time and no additional complications. Patients undergoing ISU have less delay prior to AUS reimplantation, leading to possible benefit in health-related quality of life (HRQL) outcomes.     

Use of the AS792 artificial sphincter following urinary undiversion

Reconstruction of the urinary tract after diversion has been successful in patients with normal innervation of the lower tracts. However, the possibility of urinary incontinence after such major surgical procedures has dissuaded many surgeons from attempting urinary undiversion in patients in whom the continence status cannot be determined accurately before the operation or who were known to be incontinent before the original diversion. For this reason, the presence of neuropathic bladder dysfunction has been considered a relative contraindication to urinary undiversion unless it can be established preoperatively that the patient will obtain urinary continence. Eight patients are reported who had successful outcome with the use of the AS792 artificial urinary sphincter to control incontinence after urinary undiversion. Because of this successful experience it is now believed that patients with neuropathic bladder dysfunction or anatomically abnormal lower tracts are no longer precluded from urinary undiversion. A variety of methods has been used to reconstruct the urinary tract, including total reconstruction of the bladder and urethra with the sigmoid colon in 1 case. In the latter case the artificial sphincter was placed around the bowel segment to provide continence. The use of the artificial sphincter around a bowel segment offers many possibilities for reconstructive procedures involving bowel in the future.     

An unusual use of AMS 800 artificial urinary sphincter cuff in the treatment of sphincteric neurogenic incontinence: case report

STUDY DESIGN: Case report of an unusual use of AMS 800 (American Medical Systems, Inc., Minnetonka, Minnesota) artificial urinary sphincter cuff in a female patient affected by neurogenic urinary incontinence. OBJECTIVE: To describe this rare surgical solution. SETTING: Department of Urology in Italy. METHODS: A 43-year-old woman affected by flaccid paraplegia, acontractile bladder and incompetent bladder neck, underwent an implantation of an artificial urinary sphincter AMS 800. After 7 years, a mechanical failure of the device occurred and pubovaginal sling (PVS) utilizing the cuff of the sphincter was employed due to the poor quality of rectus fascia and the development of previous allergy for some heterologous materials. RESULTS: At 17 months follow-up, the patient is content and able to empty the bladder by clean intermittent self-catheterization (CIC). CONCLUSION: The risk of developing an allergy reaction due to the employment of heterologous materials and the impossibility to use the rectus fascia obliged us to adopt the pre-existent cuff of the artificial urinary sphincter AMS 800.     

Radical prostatectomy incontinence and the AS791 artificial urinary sphincter

The AS791 prosthetic sphincter was implanted in 66 patients with urinary incontinence after radical prostatectomy. Of these patients 49 (74 per cent) were continent 3 months to 4 1/2 years after implantation. Excluding the 22 patients who had had previous pelvic radiation therapy 41 (93 per cent) were continent. Mechanical problems have been few, establishing the reliability of this unique sphincter mechanism.     

Factors determining the outcome following implantation of the AMS 800 artificial urinary sphincter

Erosion and infection are major complications following implantation of the AMS 800 artificial urinary sphincter. In the present study, 17 patients with this prosthesis were investigated urodynamically. All were continent. Urethral pressure profilometry showed a significantly lower intra-urethral pressure than would have been expected from the pressure installed in the pressure regulating balloon during operation. The maximal urethral pressure was 69.9% of the expected pressure and did not vary significantly in relation to the various balloon pressures. The mean maximal urethral pressure (+/- SEM) between the cuff when inflated and when deflated was also significantly different, although the absolute difference was small (14.1 cm H2O +/- 10.0). There was good correlation between maximal urethral pressure and urethral leakage pressure as measured by retrograde perfusion sphincterometry. The mean functional urethral length became significantly longer after implantation of the cuff. A combination of low urethral pressure and increased functional length may help to prevent cuff erosion and maintain continence.     

Treatment of the epispadias-exstrophy complex with the AS792 artificial urinary sphincter

The AS792 artificial urinary sphincter was implanted in 11 incontinent patients with the epispadias-exstrophy complex. To date 10 patients (91 per cent) are totally continent of urine with normal renal function and intact urinary systems. The recent reports concerning success with bladder neck reconstruction in this syndrome are reviewed. Owing to the relatively poor success of this procedure in achieving total urinary continence it is recommended strongly that insertion of the artificial urinary sphincter be the initial anti-incontinence procedure for these patients. The success rate with the artificial sphincter currently is superior to any form of bladder neck reconstruction in patients with the epispadias-exstrophy complex.