Efficacité de la bandelette 4 bras de type VIRTUE ® dans la prise en charge de l’incontinence urinaire masculine à l’effort: étude rétrospective

25 septembre 2019

Auteurs : A. Abdullah, F. Machkour, E. Bouchet, X. Plainard, A. Descazeaud
Référence : Prog Urol, 2019, 10, 29, 490-495



Male stress urinary incontinence (SUI) is a common complication following radical prostatectomy that could inversely impact patient's comfort and their quality of life (QoL) [1]. With a prevalence reaching up to 30% [2], only about 6% of patients seek surgical attention in order to improve their situation [3].

Many innovations are introduced in order to ease this bothersome symptom. Among those, the artificial urinary sphincter (AUS) is the standard of care [4]. Peri-urethral bulking agents, adjustable continence therapy (ex. Balloon ProACT), and male slings are other modalities. With its high safety profile and the lack of device management, male slings might be an alternative to AUS [5]. Over the slings that are available in the market, the Virtue male sling (Coloplast - Humlebaek, Denmark) has an interesting dual action; urethral elevation and compression (6). This sling showed in most available series an encouraging data with success rates ranging between 70% and 100% [6, 7, 8]. However, only McCall et al. have shown high failure rate of 68% [9].

In order to assess the effectiveness of this sling, we have conducted a retrospective study in our institute to measure the success rate and its impact on the quality of life. Sling safety and predictive factors of success were also evaluated.

Methods and Participants

Study Design

This is a retrospective study where patients visiting urology outpatient clinic between January 2016 until May 2018 and treated with the implantation of the Virtue male sling were included. The study aimed to measure the success rate and impact on the quality of life.

Participants selection

All patients presented to our institution outpatient clinic and treated with Virtue male sling between January 2016 until May 2018 were included. Pre-operative work-up included cystoscopy and urodynamic study. History of Predominant SUI, no urethral stenosis, and absent of major compliance defect were the operative indication implanting this sling.

Included participants were divided into three categories based on incontinence severity. Severity was measured according to number of pads used per day and/or 24-hour pad test and divided into three categories and summarized in Table 1.

Measurement of Outcomes

The first outcome measurement was the functional result on incontinence (corrected, improved, and failed) which is summarized in Table 1. The second outcome was assessed by using a self-administered questionnaire (ICIQ-UI sf) preoperatively and at 3 months post-operative outpatient visit. The (ICIQ-UI sf) is a validated French version of international consultation on Incontinence Questionnaire urinary incontinence short form. Predictive factors of surgical results were assessed. Intra and post-operative complications were recorded.

Statistical analysis

Kendall's rank correlation coefficient (tau-b) was used to measure relationship between ranked discontinued data. While analysis of variance (ANOVA test) was applied to compare the means of the ICIQ-UI score in the three groups (corrected, improved, and failed). Two tailed P value of 5% or less was considered significant.

Ethical considerations

This study gained hospital ethical committee approval to be conducted (registration number: 294-2019-69) (Appendix A).


Population description

Thirty-five patients were included in our study within the mentioned period with a mean follow up time of 11 months (range: 3-26). All patients were operated by two main senior surgeons. The personal, demographic and clinical characteristics are summarized in Table 2. Radical prostatectomy was considered the main cause of SUI in our cohort (82.8%). Thirty-one patients (87%) had completed the pre and post-operative ICIQ-UI sf questionnaire. Nine patients were shown to have past treatment of their incontinence of which 3 (8.6%) had sling placement, 5 (14.2%) were injected with bulking agent, and only 1 (2.8%) had balloon ProACT. The incontinence severity was judged by PPD, as only 14 (40%) patients were found to have a documented 24hours pad test.

Continence outcome

The success rate was estimated at 83% (23 corrected and 6 improved). Patients who presented with mild incontinence showed higher continence correction in compare to a more severe form (84% vs 43%). In patients who have had radiotherapy (total of 9), only 3 patients were corrected, and 2 others were improved. All patients treated for incontinence following benign prostatic hyperplasia endoscopic surgery (3 patients) and in the two neurological patients (spinal cord injury of which one underwent radical prostatectomy) bothered by leakage between their intermitted catheterization were found dry (no pad usage) at follow-up visit.

Quality of life outcome

The mean post-operative ICIQ-UI sf in the corrected and improved groups showed significant improved in compare to the pre-operative period. On the other hand, worsen score was noted in the failure group (Table 3).


We did not document any serious adverse events (grade 3,4). All complications encountered were graded I and II according to Clavien Dindo classification (Table 4). Of notice, the risk of foreign body related adverse events were discussed with SCI patients and only one grade I complication was documented (wound dehiscence) and managed with simple dressing.

Analysis of predictive factors

Radiotherapy, low bladder compliance, and incontinence severity were found to be negative predictive factors for success (Table 3). The 3 patients who encountered postoperative acute urinary retention, could spontaneously void their bladder after 1 to 3 days of catheter, and were all cured of incontinence. All other parameters and clinical characteristics did not show to have any statistical impact.


Male urethral slings have a different mechanism of action of those used for females. Since the work of Barry et al. in 1961, different slings have been introduced in the field [10]. Unlike the AUS, patients might often choose slings over AUS giving its simplicity and low complication rate [11, 12]. However, patients should be fully informed about short data results of slings effectiveness and available alternatives. In our present Virtue series, higher success rate was observed (83%). This rate is slightly higher than that of the ADVANCE sling-the most studied one- which is around a 78% [13, 14, 15, 16] which could be attributed to sling type. Concerning the Virtue Sling, Ferro et al. who used multiple post-operative result assessments notably 24h pad test, number of protections per day, PGI-I and score ICIQ-UI they achieved 58% no pad usage in their 29 post- prostatectomy SUI cohort [7]. Although higher no pad usage (66%) noticed in our series, population heterogenicity and different evaluation criteria could be attributed to this slight difference.

Unlike what has been described regarding this sling, McCall et al. reported high failure rate of 68% [9]. On the contrary, it appears that the patients' profile especially age, BMI, and comorbidities in their series is different from ours. Worthy to mention that sling fixation and retrograde leak point pressure were not clearly elucidated in their implantation technique which could lead to such functional result.

Our results reflect the experience of a single institute implanting this type of sling. With a mean pre-operative pad test of 128ml, Ferro et al. achieve 58% dry patient and improvement in the rest [7]. Similarly, we have well noticed in our study that patient with milder incontinence have better post-operative results. In addition, we fixed the retropubic arms over the pubic rami and this maneuver is well demonstrated to be associated with much better objective reduction in pad weight in comparison to non-fix (79% vs. 41.9%) [6].

Sourial et al. tried to adjust the retropubic arms pressure by carrying out a RLPP at 60cm H2O and they confirm better outcome in compare to cystoscopic verification (70% vs. 39%) [8]. On the other hand, we applied maximum pull up tension over those arms before fixing them.

It is mentioned that the radiotherapy which brought about tissue rigidity is associated with sling failure in some series [6, 17]. As a consequence, the pressure effect applied over the urethral appears to be attenuated.

Lacking confirmatory studies, it is not well established that compliance defect would be considered as surgical contraindication for the fear of back pressure rise jeopardizing the upper urinary tract [18]. Certainly, no urodynamic parameters can predict the post-operative outcome [19, 20]. Notwithstanding, it is worthwhile to do a urodynamic study to assure good bladder function and to document the absence of urge incontinence and bladder outlet obstruction [21, 22].

The limitation of this study comes from its retrospective nature and short follow-up period. Moreover, the criteria of using PPD - regardless of their size- for severity estimation is more of a subjective manner and there could be an overlapping in severity. Nevertheless, QoL improvement noticed in this cohort appears to be a good objective tool that could overcome this barrier. Although a statistical significance was obtained in several test of the analysis, this should be interpreted with caution giving the small number of patients included in each group and the repetition of the test performed. It is worth mentioning that the heterogenicity of methodology, and outcomes measurements used in most VIRTUE series made it difficult to establish our methodology in order to show a clearer comparison.


With appealing efficacy and low complication rate, the VIRTUE male sling when choosing the appropriate candidate seems to be an effective intermediary in treating SUI at short term.

Disclosure of interest

The authors declare that they have no competing interest.


This research upon passing the ethics committee meeting addressed that no funding or financial aids were received.


We would like to express our special gratitude and appreciation to Professor Jean Philippe Dumas who inspired all of us during all those years in the field of urology.

Appendix A. Supplementary data

(500 Ko)

Table 1 - Severity assessment and outcome measurement.
  PPD  24h pad test 
Mild  ≤ ≤100ml 
Moderate  3-4  101-200 
Severe  ≥ >200ml 
Outcome measurement     
Success  Corrected  No pad usage or the use of one pad by precaution (dry) 
  Improved  ≤1 PPD or those who cut down their pad usage by ≥50% 
Failure  Unchanged or worsen  No change in their pad usage, or cut down their pad usage by ≤50%, or increase in their pad usage from baseline, or the impression of worsening incontinence 

Table 2 - Patients' characteristics and demography.
  Overall  Mild  Moderate and severe   
N (%)  35  19 (54.3%)  16 (45.7%)   
Age - mean (SD)  67.8 (±8.5)  67.9 (±6.9)  67.6 (±7.4)   
BMI (Kg/m2) - mean (range)  25.7 (±2.1)  25.9 (±1.6)  25.4 (±2.6)   
Medical History         
Score ASA-mean (SD)  2 (±0.71)  2.2 (±0.5)  1.8 (±0.7)   
Diabetes millitus  3 (8.6 %)  0 (0%)  2 (12.5%)   
Cardiomyopathy  9 (25.7 %)  6 (31.5%)  3 (18.7%)   
Respiratory failure  4 (11.4 %)  1 (5.2%)  3 (18.7%)   
Smoking  3(8.6 %)  2 (10.5%)  1 (6.2%)   
Prostate cancer  32 (91.4 %)  16 (84.2%)  16 (100%)   
Benign prostatic hyperplasia  3 (8.6 %)  3 (15.7%)  0 (0%)   
Neurological bladder  2 (5.7 %)  2 (10.5%)  0 (0%)   
RPa  29 (82.8%)  14 (73.7%)  15 (93.7%)   
RTb  9 (25.7%)  4 (21%)  5 (31.2%)   
SCIc  2 (5.7%)  2 (10.5%)  0 (0%)   
HIFUd  1 (2.8%)  0 (0%)  1 (6.2%)   
Endoscopic treatment  3 (8.5%)  3 (15.7%)  0 (0%)   
Normal compliance  32 (91.4%)  17 (89.4%)  15 (93.7%)   
Low compliance  3 (8.5%)  2 (10.5%)  1 (6.2%)   
Detrusor hyperactivity  3 (8.5%)  2 (10.5%)  1 (6.2%)   
Cystomanometric capacity ml, mean (95% CI)  351.4 (350.3-352.4)  374.6 (373.2-376.1)  323.7 (322.2-325.1)   
MUCPecm H2 O, mean (95% CI)  42.3 (42.2-42.5)  42.4 (42.2-42.6)  42.5 (42.3-42.7)   

Radical prostatectomy.
Spinal cord injury.
High intensity focal ultrasound.
Maximum urethral closure pressure (Radiotherapy patients' results were removed from analysis).

Table 3 - Results.
  Corrected (23)  Improved (6)  Failure (6)  P -value 
No  20  0.019 (tau-b) 
Surgeon 1  11   
Surgeon 2  12  0.4 (tau-b) 
Mild  16   
Severe  0.004 (tau-b) 
Normal  23   
Low  0.05 (tau-b) 
No  20  0.05 (tau-b) 
ICIQ-UI score Mean (SD)         
Pre-operative  15.1 (±1.7)  16.5 (±2.0)  17.1 (±1.8)   
Post-operative  5.7 (±2.8)  9.7 (±0.9)  21.1 (±2.4)  <0.001 (ANOVA) 

Acute urinary retention.

Table 4 - Complications.
Complication  Frequency 
Pain  17 
Persisting pain 
Wound problem 

Acute urinary retention.
Urinary tract infection.


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