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




 




Introduction


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).


Results


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).


Complications


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.


Discussion


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.


Conclusion


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.


Funding


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



Acknowledgments


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 
Severity     
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%)   
 
Pathology         
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%)   
 
Mechanism         
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%)   
 
Cystomanometry         
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)   



[a] 
Radical prostatectomy.
[b] 
Radiotherapy.
[c] 
Spinal cord injury.
[d] 
High intensity focal ultrasound.
[e] 
Maximum urethral closure pressure (Radiotherapy patients' results were removed from analysis).


Table 3 - Results.
  Corrected (23)  Improved (6)  Failure (6)  P -value 
Radiotherapy         
Yes   
No  20  0.019 (tau-b) 
 
Surgeon         
Surgeon 1  11   
Surgeon 2  12  0.4 (tau-b) 
 
Severity         
Mild  16   
Moderate   
Severe  0.004 (tau-b) 
 
Compliance         
Normal  23   
Low  0.05 (tau-b) 
 
AURa         
Yes   
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) 



[a] 
Acute urinary retention.


Table 4 - Complications.
Complication  Frequency 
AURa 
UTIb 
Pain  17 
Persisting pain 
Hematoma 
Urgency 
Wound problem 



[a] 
Acute urinary retention.
[b] 
Urinary tract infection.


References



Montorsi F., Wilson T.G., Rosen R.C., et al. Best practice in robot-assisted radical prostatectomy: recommendation of the Pasadena Consensus Panel Our Uro 2012 ;  62 : 368-381 [cross-ref]
Ficarra V., Novara G., Rosen R.C., et al. Systematic review and meta-analysis of studies reporting urinary continence recovery after robot-assisted radical prostatectomy Our Uro 2012 ;  62 : 405-417 [cross-ref]
Kim P.H., Pinheiro L.C., Atoria C.L., et al. Trends in the use of incontinence procedure after radical prostatectomy: a population based analysis J Urol 2013 ;  189 : 602-608 [cross-ref]
Herschorn S., Bruschini H., Comiter C., et al. Surgical treatment of stress incontenence in men; Committee of the international consultation on incontinence Neurourol Urodyn 2010 ;  29 : 179-190 [cross-ref]
Van Bruwaene S., De Ridder D., Van der Aa F. The use of sling vs. sphincter in post-prostatectomy urinary incontinence BJU Int 2015 ;  116 : 330-342 [cross-ref]
Comiter C.V., Rhee E.Y., Tu L.M., Herschorn S., Nitti V.W. The virtue sling--a new quadratic sling for postprostatectomy incontinence--results of a multinational clinical trial Urology 2014 ;  84 (2) : 433-438 [inter-ref]
Ferro M., Bottero D., D'Elia C., Matei D.V., Cioffi A., Cozzi G., et al. Virtue male sling for post-prostatectomy stress incontinence: a prospective evaluation and mid-term outcomes BJU Int 2017 ;  119 (3) : 482-488 [cross-ref]
Sourial M.W., Richard P.O., Morisset J., Jundi M., Tu L.M. Retrograde leak point pressure measurement improves outcomes of the Virtue male sling for postprostatectomy incontinence Can Urol Assoc J 2017 ;  11 (7) : E271-E276
McCall A.N., Rivera M.E., Elliott D.S. Long-term follow-up of the virtue quadratic male sling Urology 2016 ;  93 : 213-216 [inter-ref]
Berry J.L. New procedure for correction of urinary incontinence: a preliminary report J Uro 1961 ; 771-775 [cross-ref]
Hajivassiliou C.A. A review of the complications and results of implantation of the AMS artificial urinary sphincter Eur Uro 1999 ;  35 : 36-44 [cross-ref]
Kumar A., Litt E.R., Ballert K.N., Nitti V.W. Artificial uriniray sphincter versus male sling for post prostatectomy incontinence- what do patient choose? J Urol 2009 ;  181 : 1231-1235 [cross-ref]
Mascle L., Descazeaud A., Robert G., Bernard J.P., Bensadoun H., Ferrier J.M., et al. Multicenter study of the advance ® suburethral sling for treatment of postoperative urinary incontinence of male Purol 2015 ;
Bauer R.M., Soljanik I., Füllhase C., Karl A., Becker A., Stief C.G., et al. Mid-term results for the retroluminar transobturator sling suspension for stress urinary incontinence after prostatectomy BJU Int 2011 ;  108 (1) : 94-98 [cross-ref]
Cornu J.N., Sèbe P., Ciofu C., Peyrat L., Cussenot O., Haab F. Mid-term evaluation of the transobturator male sling for post-prostatectomy incontinence: focus on prognostic factors BJU Int 2011 ;  108 (2) : 236-240 [cross-ref]
Kretschmer Alexander, Grabbert Markus, Sommer Anne, Stief Christian G., Bauer Ricarda M Mid-term outcomes after AdVanceXP male sling implantation BJU Int 2016 ;  118 (3) : 458-463 [cross-ref]
Rehder P., Freiin von Gleissenthall G., Pichler R., Glodny B. The treatment of postprostatectomy incontinence with the retro- luminal transobturator repositioning sling (Advance): lessons learnt from accumulative experience Arch Esp Urol 2009 ;  62 : 860
Jura Y.H., Comiter C.V. Urodynamics for postprostatectomy incontinence: when are they helpful and how do we use them? Urol Clin North Am 2014 ;  41 (3) : 419-427 [inter-ref]
Gomha M.A., Boone T.B. Artificial urinary sphincter for post-prostatectomy incontinence in men who had prior radiotherapy: a risk and outcome analysis Urol 2002 ;  167 (2 Pt 1) : 591-596 [cross-ref]
Thiel D.D., Young P.R., Broderick G.A., Heckman M.G., Wehle M.J., Igel T.C., et al. Do clinical or urodynamic parameters predict artificial urinary sphincter outcome in post-radical prostatectomy incontinence? Urology 2007 ;  69 (2) : 315-319 [inter-ref]
Hennessey D., Hoang N., Ganti J. Impact of bladder dysfunction in the management of post radical prostatectomy incontinence - a review Trans Androl Urol 2017 ;  6 (Suppl. 2) : S103-S111
Mathieu R., Benchikh A., Azzouzi A.R., Campeggi A., Cornu J.N., Delongchamps N.B., et al. Initial assessment of male non-neurogenic incontinence: systematic review of the literature by the LUTS committee of the French Urological Association Prog Urol 2014 ;  24 (7) : 421-426 [cross-ref]






© 2019 
Elsevier Masson SAS. Tous droits réservés.