Performance of the artificial urinary sphincter implantation in men with urinary incontinence. Results from a contemporary long-term real-world nationwide analysis.

Zuluaga L1, Plata M1, Castaño J2, Schlesinger R3, Salazar M4, Silva J5, Benavides-Martinez J2, Santander J1, Garzón D6, Carvajal A2, Echeverry M3, Azuero J1, Serrano B7, Varela D5

Research Type

Clinical

Abstract Category

Continence Care Products / Devices / Technologies

Abstract 132
On Demand Continence Care Products / Devices / Technologies
Scientific Open Discussion Session 15
On-Demand
Incontinence Surgery Male
1. Fundación Santa Fe de Bogotá, 2. Clínica CES, 3. Hospital Militar Central, 4. Clínica FOSCAL, 5. Hospital Universitario San Ignacio, 6. Clinica FOSCAL, 7. Clínica Marly
Presenter
L

Laura Zuluaga

Links

Abstract

Hypothesis / aims of study
Urinary incontinence is a common complication after radical prostatectomy. In patients with severe urinary incontinence, surgical treatment is recommended, especially for those who have failed other conservative measures. International guidelines recommend the artificial urinary sphincter (AUS) as the gold standard. Nowadays, the AMS 800 (Boston Scientific) is the device with the longest follow-up and the greatest level of evidence.  An estimated 20,790 AUS were implanted in the last decade only in the United States. The device was first introduced in 1972 with the AMS 721 (American Medical Systems) and has been improved until the current model of 3 parts AMS 800.  Surgical techniques involve either via penoscrotal (PS) or perineal (PN) approach, and cuffs are available in different sizes. In selected cases, a double‐cuff placement can be required. This variability requires surgical expertise for implant selection.  Most of the current knowledge comes from high-volume centers, but little is known about the performance of this surgery from community practice. This study aims to report the contemporary AUS performance in a nationwide descriptive survey using proms for the assessment.
Study design, materials and methods
A total of 17 centers and approximately 21 surgeons were evaluated in a multicenter retrospective descriptive study.
Patient-reported outcomes (PROMS) were approached, inquiring about the perception of the severity of their incontinence before and after surgery using The Visual Analogue Scale (VAS) of 0-10, with 0 being no incontinence and 10 severe incontinence. Quality of life (QoL)questions were also addressed, describing the patient's current situation focused on how much discomfort his urinary situation causes him. Other questions regarding ease of use, the pain or discomfort they feel when using it, and whether they would recommend the use of the device to other patients, friends, or relatives in the same condition were addressed. Retrospective data collection and descriptive analysis were done. Kaplan-Meier analysis was used to determine time to sphincter removal.
Results
A total of 215 patients were included. Mean age was 67 ± 9.4 and mean follow-up was 6.0 ± 4.4 years. Most patients, 81%, had radical prostatectomy as incontinence cause. 93.5% of patients were in the moderate to very severe incontinence category, and according to PADS use, 55.3% of the patients had moderate incontinence. Complications <30 days occurred in 11%, and 18.9% in >30 days. The most frequent cause of additional procedure was transurethral cystoscopy 19 (41.3%), revision of the AUS 11 (23.9%), cystostomy 7 (15.2%). The percentage of mechanical failure of the sphincter was 2.8%. Sphincter removal was found in 50 (22.9%), the sphincter survival rate at 2, 5, 8, 10, and 14 years was approximately 76%, 70%, 60%, 57%, and 17%, respectively according to Kaplan-Meier analysis. The mean IPSS score indicates mild-moderate lower urinary tract symptoms. The postoperative ICIQ reported moderate UI; 89.6% did not use a diaper. Evaluating subjective severity, patients had a decrease of at least 4.5 points in VAS in the postoperative assessment; 80.7% defined their urinary condition as "does not cause or causes minor discomfort." Only one patient out of 100 reported that the device was not easy to use, and 92.7% considered that they had neither pain nor discomfort when handling the device and finally, 99% of patients would recommend the device to a friend or relative in the same conditions.
Interpretation of results
A review of the general and community practice of the placement of the AUS AMS 800 was carried out, finding that most of the patients were taken to surgery with the adequate indication given for severe urinary incontinence classified through the use of PADS or prior ICIQ. However, high heterogeneity was found in the antibiotic management and preoperative approach of the patient.

Additionally, in the postoperative results, early complications related to retention and urinary tract infections were found. Regarding long-term complications, the most frequent complication was the erosion of the cuff in the uterus and the device's failure. However, this accounts for only 9 and 6 patients, respectively. According to the Kaplan - Meier analysis, it was found that the survival rate of the sphincter is low above 10 - 14 years of follow-up.

Despite these complications, the rate of improvement is encouraging, and the patients report improvement concerning the previous values. Additionally, the non-use of a diaper and the questions related to PROMS show that after the intervention, the quality of life improved and that the symptoms were not a  burden. Finally, they define the sphincter as an easy device to use that does not generate discomfort or pain, and they would recommend it to other people in their same condition.
Concluding message
The AUS AMS-800™ performs well, patients consider it a good system and are satisfied with the results in the medium and long term. It needs to be addressed in preoperative evaluation the possibility of having the AUS removed, and the need of revision after AUS placement.
Figure 1
Figure 2
References
  1. Kim SP, Sarmast Z, Daignault S, Faerber GJ, McGuire EJ, Latini JM. Long-term durability and functional outcomes among patients with artificial urinary sphincters: a 10-year retrospective review from the University of Michigan. J Urol. 2008 May;179(5):1912-6. doi: 10.1016/j.juro.2008.01.048. Epub 2008 Mar 18. PMID: 18353376.
  2. Kretschmer A, Nitti V. Surgical Treatment of Male Postprostatectomy Incontinence: Current Concepts. Eur Urol Focus. 2017 Oct;3(4-5):364-376. doi: 10.1016/j.euf.2017.11.007. Epub 2017 Nov 23. PMID: 29174616.
  3. Hussain M, Greenwell TJ, Venn SN, Mundy AR. The current role of the artificial urinary sphincter for the treatment of urinary incontinence. J Urol. 2005 Aug;174(2):418-24. doi: 10.1097/01.ju.0000165345.11199.98. PMID: 16006857.
Disclosures
Funding Private funding for research was obtained as an independent research initiative, granted by Boston Scientific Corporation (BSC). Clinical Trial No Subjects Human Ethics Committee Fundación Santa Fe de Bogotá Helsinki Yes Informed Consent Yes
08/05/2024 23:03:05