The two-year outcome of the I-Stop TOMS™ transobturator sling in the treatment of male stress urinary incontinence in a single centre and prediction of outcome

25 décembre 2013

Auteurs : J. Drai, R. Caremel, J. Riou, P. Grise
Référence : Prog Urol, 2013, 17, 23, 1494-1499




 




Introduction


The incidence of urinary incontinence post-prostatectomy (UIPP) varies from 10 to 87% [1, 2]. It affects the patient's quality of life (QOL) even when only one pad is used per day [3].


Severe incontinence is treated by implanting an artificial sphincter (AS), which today remains the gold standard, but slight or moderate incontinence may be treated with periurethral injections, periurethral adjustable continence therapy (ACT) balloons or suburethral male slings (MS) in order to improve the continence with a minimal invasive surgery. The aim of this study was to evaluate the results of the TOMSâ„¢ bulbar-transobturator suburethral male sling with four arms to treat slight to moderate UIPP at 1year then 2years follow-up and to search predictive factors of success.


Material and methods


Structure of the study


A prospective single centre study in a series of 26 patients operated on by the same surgeon was reported. Patients gave their informed written consent to be included in the study, which was approved by the local Ethics Committee.


Inclusion criteria were: slight to moderate UIPP; urinary physiotherapy failure; prostatectomy more than 1year previously. Exclusion criteria were: sign of recurrence on PSA, radiotherapy, neurological disease, urethral or anastomotic stenosis confirmed by urethrocystoscopy or urethrography, detrusor overactivity with leak from bladder contraction, chronic urinary retention or current urinary infection.


Slight incontinence was defined as one to two pads per day, moderate incontinence as three to four pads, severe as equal or more than five pads.


Data collection


The data collected were: patient's age; RP-MS time (delay in months between radical prostatectomy and MS); UD (urodynamics recording bladder compliance, maximum bladder capacity, maximum urethral closure pressure, and detrusor activity); uroflowmetry (recording maximum flow rate, urine volume and post-urination volume obtained from a bladder scan); ICIQ questionnaire score: based on three questions concerning the leakage and Quality of life affected by leakage, the total value varying from 0 (no incontinence) to 21 (major incontinence); SF36 questionnaire Score: specific score on urinary incontinence and QOL. The total value obtained varied from 0 (major incontinence) to 500 (no incontinence); number of pads per day; 24hour Long Pad-Test (LPT) according to ICS recommendations [4]; occurrence of early postoperative complications; Index of satisfaction based on two questions, each had four items i.e. very satisfied, satisfied, dissatisfied and very dissatisfied. The two questions were "What do you feel about the surgery performed?" and "What is your opinion about your condition after the operation compared to your previous condition?"; A Visual Analogic pain scale (VAS) range 0 to 10.


The timetable for data collection was before surgery; during hospital stay; at 30, 90, 180 and 360days after surgery. A telephone interview was added more than 2years postoperatively using the same evaluation based on the ICIQ questionnaire plus a specific questionnaire i.e.: do you suffer from urine leakage: yes or no? How many pads do you use per day on average?


Surgical technique


The technique was previously described by Grise et al. [5]. The shape of the tape is a rectangle with four arms extension (two on each side). Its structure is made of polypropylene monofilaments organized into a macroporous mesh.


Patient classification results:

group A: patient cured: if the following four criteria were number of pads 0 or 1; LPT 0g; SF36 score 500; ICIQ score 0;
group B: patient improved: if the following four criteria were reached i.e. number of pads reduced by more than 50%, or equal to 0 or 1; LPT reduced by more than 50%; improved SF36 or ICIQ score;
group C: patient failure. It could be either a patient slightly better (number of pads reduced by less than 50%, or equal to or 2 or more; LPT reduced by less than 50%; SF36 score improved; ICIQ score improved) or a patient complete failure.


Statistical analysis


The preoperative and one-year postoperative characteristics were compared using the Wilcoxon, or the Friedman test, non-parametric Rank test on related series. The preoperative characteristics of cured and non-cured patients were compared with the Mann-Whitney non-parametric Rank test. Analyses and graphical representations (boxplot and stripchart) were performed using R-2.14.0 software for Windows.


Results


Descriptive analysis of the preoperative population


Radical prostatectomy was performed 48.4 months (12-156) earlier and average patient age was 67.3years (54-80). Preoperatively, the mean number of pads used daily was 2.3 (1-4) with an average weight loss of 207.1g (24-1100) at LPT.


Characteristics of the hospital stay


In 24 of the 26 patients (92.3%): no postoperative complications were reported. One patient presented with a small haematoma near the site of the incision, while another patient experienced pain conducting to 24hours-delayed discharge from hospital. Postoperative pain was evaluated at 2 [range 0-7] on a VAS. The index of satisfaction was very satisfied or satisfied for 25 patients (96.1%) but one patient was dissatisfied due to the persistence of incontinence.


Results of male slings 1year after surgery


As regards the ICIQ score, 14 patients (54% [CI95: 33%-73%]) had an ICIQ score evaluated at 0 1year after surgery, whereas the 12 others all had an improved score (46% [CI95: 27%-67%]). The median ICIQ score changed from 14.5 [11-18] preoperatively to 0 [0-12] 1year after surgery. The difference was statistically significant (P <0.001).


SF36 scores showed that 13 patients (50% [CI95: 30%-70%]) obtained the maximum score of 500, while the 13 others (50% [IC95: 30%-70%]) had an improved score. Between D0 and D360, there was a significant improvement in the median SF36 score, which changed from 83 [range 0-167] preoperatively to 425 [range 83-500] 1year after the operation (P <0.001).


As regards results of the LPT, 15 patients (58% [CI95: 37%-77%]) obtained a nil final weight, while the 11 others (42% [CI95: 23%-63%]) all had a lower urinary loss weight. The median LPT changed from 207g [24-1100] preoperatively to 22.5g [0-200] 1year after surgery. The difference was statistically significant (P <0.001).


Number of pads (Figure 1): all patients reduced their number of pads, with 15 patients (58% [IC95: 37%-77%]) no longer using any pads, 10 patients (39% [IC95: 20%-59%]) only using one, and one patient (4% [IC95: 0%-20%]) using three pads per day. The median number of pads used varied from 2 [1-4] to 0 [0-3] 1year after surgery.


Figure 1
Figure 1. 

Results on continence according to pad per day during the follow-up period.




Results of male slings 2years after surgery


Twenty-one patients were evaluated at more than 2years post-surgery, with a median period 35months (24-48). Concerning daily number of pads used (Figure 1): 12 patients used respectively 0 pads (57% [IC95: 34%-78%]), seven patients used one pad per day (33% [CI95: 15%-57%]), one two pads (5% [CI95: 0%-24%]), one three pads (5% [IC95: 0%-24%]). Daily use of pads compared with the number used prior to surgery decreased significantly (2 [range 1-4]; P <0.001), but there was no difference when compared to 1year.


Concerning ICIQ score: 10 patients (48% [IC95: 26%-70%]) had a score 0, 11 patients (52% [IC95: 30%-74%]) had a better score than before surgery and five patients among these (24% [IC95: 8%-47%]) had a worse score than at the 1year evaluation.


The median ICIQ score was 2 [0-15], significantly lower than the preoperative score (which was 14 [11-18]; P <0.001). There was no significant difference from the score obtained at 1year.


Group results at 1 and 2years after surgery


At 1year: 13 patients were cured (group A) (50% [IC95%: 29.9-70.1]), 12 patients were improved (group B) (46.2% [IC95%: 26.6-66.6]), one patient was slightly better but considered as failure (group C) (3.8% [IC95%: 0-19.6]) and 0 patients had complete failure (0% [IC95%: 0-13.2]).


At 2year: 10 patients (47.6% [CI95: 25.7%-70.2%]) were cured (no leakage, 0 pads and ICIQ score of 0), nine patients (42.8% [CI 95: 21.8%-66.0%]) were improved (leakage with the use of a single pad per day and an improved ICIQ score), two patients (9.5% [CI95: 1.2%-30.3%]) experienced treatment failure (leakage with the use of two or more pads). The results are summarized on Figure 2.


Figure 2
Figure 2. 

Results on continence according to % of the total number of patients and to classification in completely dry (A), improved (B), failure (C).




Predictive factors of success


In order to identify factors predictive of success, two groups were considered: a completely dry group (group A), and a no dry group (group B and C). All the preoperative data were successively tested, in order to search for a significant difference between the success group and the failure group, defined as P <0.05. (Mann-Whitney-Rank test). The only predictive of success factor was a low LPT, with a median of 50 gm in the completely dry group as compared to 200g in the non-dry group (P =0.024).


Discussion


Our series has shown that half of the patients with slight or moderate post-prostatectomy incontinence may be cured and that more than 90% had 0 to 1 pad per day, these good results were similar at 1 and 2years.


A comparison of our continence results with those described in the literature is difficult due to the variable definition of success, which has not been standardized. If success is defined by the wearing of a maximum daily 0 to 1 pad, our series showed a 96.2% success rate 1year after surgery and a 90.5% success rate after 2years (median elapsed time of 35 months). In comparison, the artificial sphincter series [6, 7] ranged from 75 to 90%, those with balloons [8] ranged from 52 to 81%, those with other slings varied widely from 40% to 96% [9]. The good results in our series are probably explained by our patient selection excluding severe incontinence and radiated patients. In fact, only one predictive factor of success in the multivariate analysis was a 50g LPT score in the completely dry group versus 200g in the non-dry group which underlines the importance to select patients based on LPT in order to propose a MS versus an artificial sphincter. A correlation of success (very much or much improved) or failure, based on LPT and Patient Global Impression of Improvement questionnaire, was also reported by Fisher et al. [10] with respectively 22.5g versus 350g.


In contrast to our study most authors reported results with only one-year follow-up. Our results, over 2years for 21 patients, were: 18 wearing the same number of pads, two deteriorated and one improved. This stability of results over time could be due to a tough transobturator attachment of the sling and a large surface over the bulbar urethra. Concerning moderate deterioration in two patients, one could assume a possible loosing of the attachment or sliding of the sling to a posterior location between the urethra and the rectum. As regards the improved patient, this may be explained by a retraction from fibrosis around the sling or a late improvement of the sphincter. Nevertheless, a long follow-up over 5 or 10years would be necessary for a better evaluation.


We must also underline the single centre single-surgeon nature of our study with a surgeon above the learning curve and experienced with the previous TOMSâ„¢ with two arms. The results after 1year in a series with 2-arm TOMSâ„¢ showed only 30% dry patients, 30% improved patients and 40% failure [11]. Therefore, the MS was modified from two to four arms. This was reported on a TOMSâ„¢ multicenter series [5] on 104 patients at 1year follow-up i.e; 59.4% of patients dry and 20.3% improved. Our results are in accordance with this series.


A comparative study [9] of two MS techniques, between bone anchor MS and transobturator TOMS MS, showed a significant decrease in pad usage in the TOMS group and a better improvement on PGI, although this was a retrospective study it confirms the favorable outcome of the transobturator sling.


There is no strict consensus concerning the choice between various techniques, even if minimal invasive techniques are preferred for minor incontinence and artificial sphincter for severe incontinence and radiated patients. In moderate incontinence, the physician and the patient may discuss between the two techniques. After implantation of an AS, the patient satisfaction varies between 85 and 95% [6, 7], however this surgery is invasive, with a revision rate of 40 to 64% at 10years [12]. In a recent study asking patients what would be their choice between a MS and an artificial sphincter, a large majority opted for the MS [13].


The TOMSâ„¢ male sling could be compared favourably to other mini-invasive techniques in regards to safety. The non-invasive nature of the transobturator route has been established on large series in women and demonstrated in an anatomical study on men [14]. The Pro-ACT® balloons procedure may reach 66% continence rate in non radiated patients [8] but numerous complications were reported i.e. bladder or urethral perforations, rupture of the balloon, urine retention, urethral or bladder erosion. The bulbar and anchored InVance® MS produced good results concerning continence rate but has been discontinued due to infection (2 to 10%), acute urine retention (3 to 4%), perineal pain (4 to 22%), and an explantation rate of approximately 10% [15]. The bulbo-membranous transobturator MS Advance® was originally proposed in order to improve tolerance, however some complications have still been reported i.e. urinary retention up to 20% but only few patients with perineal pain [16, 17, 18]. Similarly to the TOMSâ„¢ location on bulbar urethra, the series involving the bulbar-transobturator Gynemesh PS® tape showed minor complications such as retention, superficial infection or chronic pain [19]. In order to make postoperative adjustments of the tension, adjustable MS has been used [20] however the amount of inserted biomaterial is possibly a factor to explain the infection complications leading to sling explantation.


In the final analysis, the positive results of TOMSâ„¢ MS need to be confirmed by a longer-term study. Nevertheless, the study does confirm the good results and good tolerance in selected patients with no radiation and minor or moderate incontinence. Comparative studies between the various techniques available, based on comparable cohorts and identical assessment criteria are warranted.


Conclusion


In the reported series of TOMSâ„¢ transobturator MS, 50% of patients obtained a full continence and 90% used no more than one pad per day at 1year after surgery. These good results were maintained at 2years. This biomaterial is an attractive option for minor and moderate post-prostatectomy incontinence.


Disclosure of interest


Philippe Grise was a invited speaker for Medtronic®, Astellas®, CL medical®, and is a consultant for Astellas® and Coloplast®. No conflict of interest for the other authors.



Acknowledgements


The authors are grateful to Richard Medeiros, Medical Editor - Medical Editing International, for editing the manuscript.



Appendix A. Supplementary data


(147 Ko)
  



References



Gray M., Petroni G.R., Theodorescu D. Urinary function after radical prostatectomy: a comparison of the retropubic and perineal approaches Urology 1999 ;  53 : 881-890 [inter-ref]
Hautmann R.E., Sauter T.W., Wenderoth U.K. Radical retropubic prostatectomy: morbidity and urinary incontinence in 418 consecutive cases Urology 1994 ;  43 : 47-51 [cross-ref]
Cooperberg M.R., Master V.A., Carroll P.R. Health related quality of life significance of single pad urinary incontinence following radical prostatectomy J Urol 2003 ;  170 : 512-515 [cross-ref]
Abrams P., Cardozo L., Khoury S., Wein A. Incontinence 4th International Consultation on Incontinence Paris: Health Publication Ltd (2009). 
1124-1126
Grise P., Vautherin R., Njinou-Ngninkeu B., Bochereau G., Lienhart J., Saussine C., et al. I-STOP TOMS transobturator male sling, a minimally invasive treatment for post-prostatectomy incontinence: continence improvement and tolerability Urology 2012 ;  79 (2) : 458-463 [inter-ref]
Van der Aa F., Drake M.J., Kasyan G.R., Petrolekas A., Cornu J.N., Young Academic Urologists Functional Urology Group The artificial urinary sphincter after a quarter of a century: a critical systematic review of its use in male non-neurogenic incontinence Eur Urol 2013 ;  63 (4) : 681-689 [cross-ref]
Bordenave M., Rouprêt M., Taksin L., Parra J., Cour F. Résultats à long terme du traitement de l'incontinence urinaire masculine par implantation de sphincter artificiel urinaire (AMS 800) en position bulbaire : expérience monocentrique Prog Urol 2011 ;  21 : 277-282
Gregori A., Romano A.L., Scieri F., Pietrantuono F., Incarbone G.P., Salvaggio A., et al. Transrectal ultrasound-guided implantation of adjustable continence therapy (ProACT): surgical technique and clinical results after a mean follow-up of 2 years Eur Urol 2010 ;  57 : 430-436 [cross-ref]
Crites M., Sorial A., Ghoniem G. Risk factors for male slings: a comparative study of two techniques Urology 2011 ;  78 (1) : 192-197 [inter-ref]
Fischer M.C., Huckabay C., Nitti V. The male perineal sling: assessment and prediction of outcome J Urol 2007 ;  177 : 1414-1418 [cross-ref]
Grise P., Geraud M., Lienhart J., LePortz B., Bubenheim M., Costa P. Transobturator male sling TOMS for the treatment of stress post-prostatectomy incontinence, initial experience and results with on year's experience Int Braz J Urol 2009 ;  35 : 706-715 [cross-ref]
Fulford S.C., Sutton C., Bales G., Hickling M., Stephenson T.P. The fate of the "modern" artificial urinary sphincter with a follow-up of more than 10 years Br J Urol 1997 ;  79 : 713-716
Kumar A., Litt E.R., Ballert K.N., Nitti V.W. Artificial urinary sphincter versus male sling for post-prostatectomy incontinence - what do patients choose? J Urol 2009 ;  181 (3) : 1231-1235 [cross-ref]
Darcq C., Guy L., Mansoor A., Vanneuville G., Filaire M., Boiteux J.P. Compression of the bulbar urethra by transobturator suburethral tape: anatomical study Prog Urol 2004 ;  14 (4) : 507-511
Lanoe M., Saussine C., Mouracade P., Azzouzi A.R., Devonec M., Ruffion A., Robert G., et al. Male stress urinary incontinence by InVance bone anchored sub-urethral sling: predictive factors of treatment failure: multicentric study by the CTMH-AFU Prog Urol 2009 ;  19 (11) : 839-844 [inter-ref]
Rehder P., Mitterberger M.J., Pichler R., Kerschbaumer A., Glodny B. The 1 year outcome of the transobturator retroluminal repositioning sling in the treatment of male stress urinary incontinence BJU Int 2010 ;  106 (11) : 1668-1672 [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]
Bauer R.M., Mayer M.E., Gratzke C., Soljanik I., Buchner A., Bastian P.J., et al. Prospective evaluation of the functional sling suspension for male postprostectomy stress urinary incontinence: results after 1 year Eur Urol 2009 ;  56 : 928-933 [cross-ref]
De Leval J., Waltregny D. The inside-out trans-obturator sling: a novel surgical technique for the treatment of male urinary incontinence Eur Urol 2008 ;  54 (5) : 1051-1065 [cross-ref]
Hoda M.R., Primus G., Fischered K., Von Heyden B., Mohammed N., Schmid N., et al. Early results of European multicentre experience with a new self-anchoring adjustable transobturator system for the treatment of stress urinary incontinence in men BJU Int 2013 ;  111 (2) : 296-303 [cross-ref]






© 2013 
Elsevier Masson SAS. Tous droits réservés.