A Single Center Trial to Evaluate the Efficacy and Safety of a New Adjustable Artificial Urinary Sphincter (VICTO): Follow-Up >12 Months

Ameli G1, Weibl P1, Rutkowski M1, Huebner W1

Research Type

Clinical

Abstract Category

Female Lower Urinary Tract Symptoms (LUTS) / Voiding Dysfunction

Abstract 202
Urogynaecology 3 - Lower Urinary Tract Symptoms
Scientific Podium Short Oral Session 9
Wednesday 4th September 2019
15:52 - 16:00
Hall H2
New Devices Stress Urinary Incontinence Male
1.Department of Urology, Teaching Hospital, Clinic of Korneuburg, Austria
Presenter
G

Ghazal Ameli

Links

Abstract

Hypothesis / aims of study
Revision and explanation rates dues to urethral atrophy and cuff erosion after Artificial Urinary Sphincter (AUS) vary considerably among published studies. In addition to general risk factors like diabetes, hypogonadism and radiotherapy, this may be attributed to high occlusion pressures(1, 2)
To evaluate the efficacy and safety of a new AUS, we investigated continence, complication and revision rates in patients after VICTO implantation as well as overall levels of satisfaction with the device.
Study design, materials and methods
VICTO is a preconnected adjustable AUS. The pressure in the occluding cuff (OC) is regulated by a small silicone balloon (pressure regulating balloon-PRB) and the control pump contains a selfsealing port for pressure adjustment. The regulating pressure is adjustable in the range 0-100 cmH2O and adjustments can be performed easily at any time after implantation by injection or removal of fluid.
In the time between December 2016 and February 2019 the device was indicated in 60 patients with stress urinary incontinence (SUI) after prostate surgery (prostatectomy n=54; transurethral prostate resection n=4; traumas=3). We included the data from 51 patients (VICTO n=22, VICTO plus n=29) with a mean follow-up time of 14.1 months (median= 13.7). Patients with more than 2 prior incontinence surgeries were excluded (n=3) and 6 systems were not activated at the time of the data collection. Functional urinary outcomes were assessed according to daily pad use and a standardized questionnaire. Data were collected as part of the follow up care of these patients.
Results
The indwelling catheter was removed after 24 hours in all included cases and prolonged antibiotic treatment (> 5 days) was required in only a few cases (n=4). The pad per day usage (p/d) improved from 6.2 (3.3) to 1.4 (±1) and the continence rate (max. 1 p/d) was 58.8% (n=30). 15 patients (29,4%) reported max. 2 p/d and 6 (11,8%) used 3 p/d, however some of these patients are not yet fully adjusted. In average there were 1.7 (median=2, IQR=1) readjustments needed to achieve a sufficient result. 
The patients were also asked to state how satisfied they were with the device and also about the continence situation. 
In total continence was rated as "excellent" or "good" by 28 patients (54,9%), only 9 (17,6%) rated their continence level as "poor". However, 6 patients will be further adjusted. The overall satisfaction was 86.4% and 88% would undergo the same operation again and recommend the procedure to others. The most common adverse events were postoperative pain and hematoma 9,8% (n=5), as well as pump operating problems 5,9% (n=3). In 2 cases urinary retention was recorded due to inability of the patient empty the cuff correctly. No revisions have been recorded due to mechanical failure, infection, erosion or atrophy. In 5 cases we have done optimizing surgeries according to our learning curve to improve the overall results (n=2 smaller cuff because of persistent incontinence, n=3 pump reposition). For validation purposes, we did subgroup analysis and compared the results of the patients with previous incontinence surgeries (n=11) and radiotherapy (n=16) with index patients. Results in term of pad per day usage were similar and showed no statistically relevant differences between the groups. No patients related risk factors were associated with increased risk of secondary surgery.
Interpretation of results
In this cohort we achieved continence rate of 59%, which is comparable to other AUS Studies, however long-term results are missing.  During an average time of 14 months, no revisions were performed due erosion or atrophy, these results favorably challenge prior AUS series.
Concluding message
The device provides adjustability in regulating pressure in situ. In this cohort we achieved a continence rate of 59% and there have been no revisions due to mechanical failure, infection, erosion or atrophy. The complete absence of erosions proves the implant to be particularly safe. These results are promising and challenge prior AUS series. Adjusting the system pressure to the lowest level providing continence may reduce the long-term rate of complications, however bigger cohorts and long-term follow-ups are needed.
References
  1. The artificial urinary sphincter after a quarter of a century: a critical systematic review of its use in male non-neurogenic incontinence. Van der Aa F1, Drake MJ, Kasyan GR, Petrolekas A, Cornu JN; Young Academic Urologists Functional Urology Group.Eur Urol. 2013
  2. Long-term Outcomes Following Artificial Urinary Sphincter Placement: An Analysis of 1082 Cases at Mayo Clinic. Linder BJ1, Rivera ME1, Ziegelmann MJ1, Elliott DS2.Urology. 2015
Disclosures
<span class="text-strong">Funding</span> I have no potential conflict of interest to report <span class="text-strong">Clinical Trial</span> No <span class="text-strong">Subjects</span> Human <span class="text-strong">Ethics not Req'd</span> it is a retrospective observation <span class="text-strong">Helsinki</span> Yes <span class="text-strong">Informed Consent</span> Yes