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Long-term efficacy and safety of artificial urinary sphincter AMS 800ТМ implantations

https://doi.org/10.21886/2308-6424-2021-9-1-14-21

Abstract

Introduction. Stress urinary incontinence in men in most cases occurs after radical prostatectomy or surgery of benign prostate hyperplasia. In addition to a significant reduction in the quality of life, the treatment and care of such patients require significant financial costs.

Purpose of the study. To study the long-term efficacy and safety of artificial urinary sphincter (AUS) implantation.

Materials and methods. AUS was implanted in 52 patients with severe stress urinary incontinence (UI) from 2004 to 2020. Urine loss was estimated by the urinary diary. A cure was considered as the use of ≤ 1 pad per day («social continence»). The quality of life was assessed using a numeric scale (from 0 to 100), IPSS-QoL, and the ICIQ-UI SF questionnaire. Complications were described according to the Clavien-Dindo classification.

Results. The median age was 67.5 years (IQR 63 - 72 years). The causes of severe stress UI were the following: radical prostatectomy - 29 (55.8%) patients, transurethral resection of the prostate — 12 (23.1%), transvesical simple prostatectomy — 5 (9.6%), others — 6 (11.5%) patients. Median time after the intervention that caused UI was 24 months (IQR 13-36 months). Both perineal (67%) and penoscrotal (33%) approaches were used. The results of implantation efficiency were evaluated in 43 patients. A significant decrease in the median urine loss from 800 ml (IQR 700 - 1100 ml) to 0 ml (IQR 0-30 ml) was registered at a median follow-up of 100.4 months (IQR 70.5 - 136.9 months). There was also a statistically significant reduction in daily pad use from 7 (IQR 6-8) to 1 (IQR 0 - 1). 36 (84%) patients met the cure criteria. Improvement was noted in 6 (14%) patients, failure - in 1 (2%) patient. Median IPSS-QoL scores decreased from 4 (IQR 4-5) to 2 (IQR 1 - 2), p < 0.05, numeric analog scale scores improved from 25 (IQR 20 - 35) to 80 (IQR 60 - 90), p < 0.05., The ICIQ-UI SF score was 7 (IQR 1-9) after treatment. Complications more than grade II according to the Clavien-Dindo classification were registered in 15 (28.8%) patients.

Conclusion. AUS implantation provides satisfactory results in reducing urine loss and improving quality of life but it's accompanied by a high rate of complications and revisions in long-term follow-up.

For citation:


Veliev E.I., Tomilov A.A., Golubtsova E.N. Long-term efficacy and safety of artificial urinary sphincter AMS 800ТМ implantations. Vestnik Urologii. 2021;9(1):14-21. (In Russ.) https://doi.org/10.21886/2308-6424-2021-9-1-14-21

Introduction

In most cases, stress urinary incontinence (SUI) in men occurs after surgical interventions on the prostate [1][2]. Any surgical or radiation interventions in the area of external urethral sphincter bear the risk of iatrogenic injury, and as a result, the development of SUI. The risk of SUI is associated with such surgery as prostate transurethral resection and transvesical adenomectomy for benign prostate hyperplasia, but primarily, radical prostatectomy, when persisting SUI is observed in 8 – 20% of patients [3][4][5].

Some population studies showed that 5 – 6% of patients after radical prostatectomy undergo surgical correction of urinary incontinence [6][7]. SUI in men significantly decreases the quality of life, patients are deprived of normal social activity, stop meeting with people, and visiting public places. Besides, the management of such patients requires significant financial costs, which makes this problem not only social but economic [8]. Presently, the implantation of an artificial urinary sphincter (AUS) that cuffs the urethra or neck of the urinary bladder is used to compensate for urinary sphincter deficiency. The study aimed to evaluate the long-term effectiveness and safety of the implantation of AUS.

Materials and Methods

52 patients with stress urinary incontinence (SUI) underwent the implantation of an artificial urinary sphincter AMS 800 in the Urology and Surgical Andrology Сlinic (Russian Academy of Continuous Professional Education, Botkin State Clinical Hospital) from 2004 to 2020.

The primary examination included the collection of anamnesis and complaints. The authors collected information on the type of surgery, complications of SUI, period of incontinence, and the dynamics of restoration of the urine continence function. Previous attempts of surgical correction and radiotherapy were recorded. A diary of urination and the daily pad test allowed the authors to identify the degree and type of SUI. During a physical examination, the authors paid attention to the scars formed after previous surgical interventions and inguinal hernias. Preservation of the mental status and the possibility of small muscular movements were evaluated.

All patients underwent standard preoperative laboratory diagnostics and bacteriological urine analysis.

The study included ultrasound examination, uroflowmetry, urethrocystoscopy with a bulbous probe, and if necessary, urethrography. The volume of the bladder, preservation of the external sphincter function, and the membranous section urethra mobility were evaluated. Urethral strictures and urethrovesical anastomosis were excluded. Some patients underwent complex urodynamic studies for the exclusion of detrusor hyperactivity and hypotonia. The criteria of exclusion were the lack of the preceding conventional therapy for SUI, urethral stricture, the prevalence of an urgent form of UI, detrusor hyperactivity or detrusor-sphincter dyssynergia, and the presence of residual urine > 50 ml. Before the implantation of AUS, each patient signed informed consent.

The main stages of implantation included the access to the bulbous part of the urethra (perineal or penoscrotal access), the measurement of the urethral circumference, the required size cuff installation, access in the retropubic space, implantation and filling of the reservoir, formation of the pump bed site in the scrotum, sealing of all the components with connector tubes (Fig. 1). The bladder was drained with a urethral catheter that was removed on the 1st day after the surgery. The activation of AUS was performed 4-6 weeks after the surgery.

During the follow-up period after the activation, the authors estimated the number of the used pads and the volume of urine leakage. If a patient used not more than one pad per day or did not use them at all, it was considered as a recovery. If a patient used not more than two pads or the reduction of the urine leakage was by more than 50%, the condition of the patient improved. The complications developed after all 52 implantations were recorded according to the modified classification of surgical complications Clavien-Dindo. The statistical analysis was performed in the software package Microsoft Office Excel, GraphPad Prism 5. Wilcoxon’s test was used to compare the associated groups. The difference was significant at p < 0.05.


Figure 1. AUS implantation steps: A – access and measurement of bulbous urethral circumference; B – cuff installation; C – reservoir installation; D – formation of bed space for the pump in the scrotum lower part (the dotted line indicates the projection of the pump)

Results

The median age was 67.5 years old (IQR 63 – 72 years). Severe SUI was caused by the following interventions: radical prostatectomy ― 29 (55.8%) patients, transurethral prostate resection ― 12 (23.1%), transvesical simple prostatectomy ― 5 (9.6%), other ― 6 (11.5%) patients. The median time after the intervention that caused SUI was 24 months (IQR 13 – 36 months). In all patients, severe SUI was diagnosed. Before the implantation of AUS, 8 patients underwent radical surgical treatment for SUI with unfavorable outcome, 2 patients received periurethral injections, 6 patients were implanted a sling, and 2 patients had both periurethral injections and sling implantation. The associated urethral stricture was observed in 29 patients.

AUS was implanted via a perineal (67%) and penoscrotal (33%) access. A cuff with a diameter from 3.5 to 4.5 cm (primarily, 4 cm ― 83%) was implanted on the urethral bulbous section. The results of the implantation effectiveness evaluation were available in 43 patients. In the rest patients, the activation time of AUS was not achieved or complications developed that prevented the use of AUS. The median observation was 100.4 months (IQR 70.5 – 136.9 months). There was a statistically significant decrease in the median urine leakage volume from 800 ml (IQR 700 – 1100 ml) to 0 ml (IQR 0 – 30 ml). Besides, there was a statistically significant decrease in the use of pads per day from 7 (IQR 6 – 8) to 1 (IQR 0 – 1). Twenty-one (49%) patients did not use pads and 15 (35%) patients used one pad for safety reasons. Thus, 36 (84%) patients got into the category of recovered (Fig. 2). The improvement was observed in six (14%) patients, the unfavorable outcome was registered in one (2%) patient. The median of IPSS QoL score decreased from 4 (IQR 4 – 5) to 2 (IQR 1 – 2), p < 0.05. The score by the digital-analogue scale improved from 25 (IQR 20 – 35) to 80 (IQR 60 – 90), p < 0.05, ICIQ-UI SF score was 7 (1 – 9) after the treatment. There were no intraoperative complications registered. The blood loss was minimal in all cases. Complications of more than II degree by the Clavien-Dindo classification were observed in 15 (28.8%) patients. Twelve patients (23%) had 20 revisions, six of them ― repeated. Partly or completely, AUS was removed in 11 (21%) patients. Detailed information and pathways of their resolution are presented in Table 1.


Figure
2. Urine loss (A) and daily pad usage (B) before and after AUS implantation

Table 1. AUS implantation complications

Complication

N (%)

Clavien-Dindo I

Acute urinary retention – catheterization

1 (2%)

Clavien-Dindo II

Urethritis – antibacterial therapy

1 (2%)

Cellulite – antibacterial therapy

1 (2%)

Clavien-Dindo IIIa

Acute urinary retention – cystostomy

2 (4%)

Urethral erosion – removal

6 (12%)

Lack of fluid – revision, fluid volume restoration

4 (8%)

Iatrogenic damage to the reservoir – replacement

1 (2%)

Mechanical failure – replacement of part/entire system

4 (8%)

Discussion

According to the International Continence Society (ICS), urinary incontinence is any involuntary urine leakage. Stress form of UI is defined as involuntary urine leakage in a person during tension, sneezing, or cough, while an urgent form of UI is preceded by an urgent urge. A combination of these symptoms indicates a mixed form of incontinence [9]. In the majority of cases, SUI in men results from surgical intervention on the prostate [1], primarily, after radical prostatectomy [3][4][5]. Currently, it is possible to choose the variants of the radical method of treatment in patients with localized prostate cancer. Thus, more and more attention is paid to the functional outcomes. The most important of them is urine continence (even more important than erectile function). A better understanding of anatomy and application of nerve-spearing technology significantly decreased the risk of SUI development after radical prostatectomy but did not eliminate it [10][11]. Paraurethral injections, sling operations, and AUS are used to eliminate SUI. There are models AMS800 and ZSI 375 among the available AUS constructions. The first model was invented by F. Scott in the 1970s. In 1983, a modification AMS 800 was designed that is used to date [2]. The device consists of a cuff placed around the urethral bulbous section or the urinary bladder neck, a pump placed superficially in the scrotum, a reservoir, and connecting tubes. The peculiarity of the sphincter ZSI 375 is a combination of a pump and a reservoir as a single unit that is connected to a cuff with a tube as well as the possibility to regulate the filling of the system with liquid [12]. In their study, Ostrowski et al. described 147 implantations with ZSI 375 in patients with severe and moderate degrees of SUI (three and more pads). The social continence reached 71-78%. During the observation, more than three years was reached only by 23 out of 147 patients. The rate of complications was 22.44%, including urethral erosion (12.92%) and mechanical damage (3.40%), and was comparable with the results of AMS 800 implantation [12][13][14][15]. One of the studies did not reveal any differences in the parameters of implantation AMS 800 and ZSI 375 [16].

In the presented group, a significant share of patients (33%) had SUI after surgical treatment of benign prostate hyperplasia (BPH), which was different from other studies, wherein the share of patients after radical prostatectomy reached 100% [17]. Besides, all patients had severe SUI. Another peculiarity is a frequent combination of SUI with a posterior urethral stricture. Untimely diagnosed stricture complicates transurethral access and the surgical treatment can lead to unfavorable outcomes because of the development of the device erosion or infectious complications. Thus, to reduce the risk of the AUS cuff erosion, the problems with the posterior urethral stricture should be resolved before AUS implantation.

Because of the low effectiveness of paraurethral injections [6] in clinical practice, the choice of the method of surgical treatment of SUI in men is made between the implantation of a sling and AUS. Sling operations allow for the preservation of a natural act of urination but they are associated with a high risk of complications [18]. Urethroscopy with a bulbous probe allows surgeons to preserve the striatal sphincter [15]. When the sphincter concentric contraction is sufficient, the probe will show that SUI resulted from the hypermobility of the urethra after surgical intervention [19][20]. It is feasible to consider the implantation of a synthetic sling. In patients with sphincter deficiency, the bulbous probe will show the lack of concentric contraction and the presence of a flat closure of the upper and lower urethral semi-circumference. In such clinical cases that are associated with severe SUI, AUS implantation is recommended.

The disadvantages of AUS include their high cost, frequent complications, and the manual activation of the device for urination [15]. Despite a high risk of complications and failure, the changes in the quality of life of patients after the sphincter implantation are so significant that they are ready to face these risks. In this aspect, the study of H. Lai should be highlighted, wherein the cases of primary implantation are compared with the revisions and re-implantations of AUS. In patients with a severe degree of SUI, the surgeon’s decision to refuse this surgery in complicated cases led to the patient’s suffering and they often insisted on a repeated surgery. The authors also noted that despite an increased risk of unfavorable outcomes and complications, experienced surgeons can perform successful treatment of SUI. Even in the most complicated cases, a transcorporal implantation of a cuff provides a possibility of SUI elimination without erosion, mechanical damage, and infectious complications [21].

Conclusion

A long-term observation showed that AUS implantation provides satisfactory results in terms of reduction of urine leakage and improvement of the quality of life. However, taking into account the rate of complications and a small share of patients that completely refused pads, AUS implantation should be defined not as the “gold standard” of treatment for SUI but as the best option that is currently available. AUS implantation is primarily relevant for patients with severe forms of SUI that resulted from the loss of the urethral sphincter function. Before the implantation, patients should be warned of a high rate of complications.

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About the Authors

E. I. Veliev
S.P. Botkin State Clinical Hospital; Russian Medical Academy of Continuing Professional Education
Russian Federation

Evgeniy I. Veliev — M.D., Dr.Sc.(M); Prof., Dept. of Urology and Surgical Andrology, Russian Medical Academy of Continuous Professional Education; Head, Urology Division, S.P. Botkin's State Clinical Hospital.

125284, Moscow, 5 2nd Botkinsky fy; 125993, Moscow, 2/1 Barrikadnaya st.


Competing Interests:

no conflict of interest



A. A. Tomilov
S.P. Botkin State Clinical Hospital
Russian Federation

Andrey A. Tomilov — M.D., Cand.Sc.(M); Urologist, Urology Division, S.P. Botkin's State Clinical Hospital.

125284, Moscow, 5 2nd Botkinsky fy; tel.: + 7 (926) 386-27-41


Competing Interests:

no conflict of interest



E. N. Golubtsova
S.P. Botkin State Clinical Hospital; Russian Medical Academy of Continuing Professional Education
Russian Federation

Elena N. Golubtsova — M.D., Cand.Sc.(M); Assist., Dept. of Urology and Surgical andrology, Russian Medical Academy of Continuous Professional Education; Urologist, Urology Division, S.P. Botkin's State Clinical Hospital.

125284, Moscow, 5 2nd Botkinsky fy; 125993, Moscow, 2/1 Barrikadnaya st.


Competing Interests:

no conflict of interest



For citation:


Veliev E.I., Tomilov A.A., Golubtsova E.N. Long-term efficacy and safety of artificial urinary sphincter AMS 800ТМ implantations. Vestnik Urologii. 2021;9(1):14-21. (In Russ.) https://doi.org/10.21886/2308-6424-2021-9-1-14-21

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