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I-STOP® TOMS® Transobturator Male Sling for Stress Incontinence

I-STOP TOMS is today the market leader in France for male slings

I-STOP TOMS has been on the market for over 5 years, first with two arms then with the current four arms. The product is CE marked and FDA approved.

In the UK, TOMS is well accepted and success rates are even higher than reported in the literature.
 
I-STOP TOMS (Trans Obturator Male Sling) is similar to female trans-obturator slings with the exception that they are inserted through the perineum rather than through the anterior vaginal wall. The TOMS procedure requires a minimum of dissection and minimal operating time. This sling procedure is simple to perform and has shown good results with few complications. 
Post operative pain is minimal and there have been no reported erosions. 

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DESIGN FEATURES                            

WATCH THE PROCEDURE    

TRAINING OPPORTUNITIES

 

CLINICAL STUDIES 

 







      

                
  
E U R O P E A N R E N A L & G E N I T O - U R I N A R Y D I S E A S E 2006 
A pilot prospective multicentre study of 50 patients with moderate incontinence has been in progress since June 2006
  • Published in late 2006, results were encouraging. 
               

    ICS 2008
  • Poster presentation 14 patients
  • Mean folow-up 18 months 
  • VAS was 2.5 post-operation, 0.9 at 1 month and 0.1 at 1 year 
  • Mean pad use reduced from 2.4 to 0.9, 50% used no pad.                                                                               
     AUA 2009 
  •   Most of the patients improved or continent with one year follow-up


 

  European Urological Review 2009
  •   96 patients - University of Rouen  
  •   "On the VAS, the median pain value the day after surgery was 2, then decreased significantly to 1.2 at 1 month and remained at 0.4 for all further visits."
  •   "Overall, median pad use decreased significantly from two pads per day before surgery to one pad per day for all visits thereafter. At one,three and six months the  number of pad free patients was,  respectively 60, 51, and 51%.
     Continence rate of use of no or one pad per day was respectively,  74, 82, and 86%

  •    
    International Braz J Urol 2009  
  •   Multicentre trial with TOMS four arm. 50 patients  
  •   "On the VAS, the median pain value the day after surgery was  2    then decreased significantly to 0 at one month and remained similar  for all further visits until the end of the study
  • "The ICIQ incontinence score (Figure 4) decreased significantly
     from 15  before the TOMS sling to 8 at one year, and the median  score was 9 for all other visits at follow-up."
                              
        
    UroToday.com  March 2010

      Male stress urinary incontinence: The place
     of alternatives to an artificial urinary sphincter, 
                               by Philippe Grise, MD
  •  More than 50% of patients were completely continent and
      more than 70% of the patients were improved in their
      continence and their quality of life.
  •  TOMS sling is a safe procedure and pain is not an issue.

              Urology 76 (Supplement 3A) September 2010                                              
                         Melanie Crites DO and Gamal Ghoniem MD
                          Cleveland Clinic Florida 
  • "Failure rate (<50% improvement) was 46.3% in BAMS and 16.7%  in   TOMS (p=0.03)"     
  •                 
                        Presentation at AUA 2011
                                    Philippe Grise et al
                           ♦ 122 patients from 30 centres
                           ♦ 93% improved at 360 day follow-up

 

Download a      PRODUCT  LEAFLET                           
                                FULL CATALOGUE 
                                PATIENT INFORMATION LEAFLET 

Watch the       SURGICAL PROCEDURE ON YouTube
  

 

DESIGN FEATURES 

The tape is specifically designed so as to not stretch. Once in position no adjustment is needed. 
The non-stretch feature may be one explanation for Initial good results being maintained and this may also contribute to the fact that there have been no erosions.

 

  Type 1 100% monofilament  polypropylene
  Macropore knitting
  Resistance to traction (no “rope effect”) 
  No particle release
  Atraumatic looped edges 
  Dimensional stability - low elasticity
  Minimal mass








The tape has two arms on each side. These are connected at the extremities to enable both arms to be together connected onto the needle before being drawn through the obturator on each side.

Before applying tension to the tape, simultaneously on both sides, the tape should be lying flat over the bulbospongiosus muscle. If it is not, this can be easily corrected by applying tension to the arms separately.


 
 









 To receive a DVD on the procedure or to arrange for training with an 
    I-STOP TOMS user 
contact Genesis Medical

 See an animation of the surgical technique         

                                        
        I-STOP for female SUI