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          Non-Stretch Tape for Stress Urinary Incontinence 

 
 
 

 

I-STOP®  for female Stress Urinary Incontinence
                                                           

                                                        I-STOP is today the market leader in France

 
  Design features
 
A comment made by one of the first users of TVT to the founder of CL medical, when he worked for Gynecare, inspired him to produce a tape designed specifically for USUI.

He was told that a tape with less stretch may be an improvement.

Just two years later, in 2002 the first I-STOP tape was implanted.

Now, after 9 years there still has been no reported erosion of an
I-STOP tape.     I-STOP is the market leader in France.
                                               
I-STOP differs from other tapes in that it does not comprise a modified hernia mesh but instead the weave was designed specifically to meet the requirements needed for USUI.

Quotations from clinical papers on I-STOP
                                               

Explanation of the importance of non-deformation from Cleveland Clinic Florida

The I-STOP tape is woven from a single filament of polypropylene there are no cut edges. It
does not stretch. It does not shed particles. Published data goes back for 8 years. Not one erosion has ever been reported.                                                              
                                                                        Skip directly to Clinical Papers

A UK gynaecologist has implanted over 500 I-STOP tapes in the past five years without any erosion.  Read articles showing  the results for 1287 patients.
Reports for other tapes show 1 - 15% erosion rates.         I-STOP is truly different.
   
                                                  
                    
                                                                          Skip directly to Clinical papers

LOOK AT THESE VIDEOS:-

Using non-stretch I-STOP for ISD
DVD by W. Davilla, Cleveland Clinic Florida


Using I-STOP for USUI  (Retropubic approach)
DVD by Dr Richard M Wood, Columbia Memorial Hospital, NY

Leading UK Urological and Gynaecological Surgeons 
showing TOT surgery using I-STOP  -  DVD

Food for thought - Peter Dwyer editorial (this is why we do not offer
any tape without strong clinical data)
                                                
 

I-STOP

Kits contain needles for more than one approach - very convenient for
hospitals where surgeons have different preferred approaches. 

 

   

I-STOP is well established - it is the market leader in France, and with users in the UK, Europe, the USA and many countries around the world.
CE marked and FDA approved.

Clinical results in numerous papers covering more over 1500 patients starting in 2003 show excellent results and
NOT ONE EROSION EVER REPORTED

• Type 1 100% monofilament  polypropylene  
• Macropore knitting
• Resistance to traction (no “rope effect”)      
• Needles for :    • TransobturatorOutside-in 
                          • Transobturator Inside-out 
                          • Retropubic suprapubic 
                          • Retropubic transvaginal
                          • Posterior approach
• No particle release
• Atraumatic looped edges
• Dimensional stability - low elasticity
• Minimal mass

The I-STOP tape construction resists deformation under stress to a far greater extent than any other tape.

This may be one explanation for the absence of erosion.

This may also explain why Willy Davila at the Cleveland Clinic Florida, in a series of 191 women treated for Intrinsic Urinary Incontinence, with the I-STOP transobturator slings, reported that there were no vaginal erosions, or need for sling revision. Subjective cure rate was 91% with 81% reporting no SUI events. Infections, vaginal pain, and incomplete emptying were minor complications in less than 0.5%


 

  Applications
 
  • Transobturator Outside-in
• Transobturator Inside-out
• Retropubic suprapubic
• Retropubic transvaginal
• Posterior approach 

                                                            CATALOGUE
                                                                                                                              

  Clinical data
 
 

2003
•Association Francais d'Urologie conference  2003- Poster (English translation)
- The Trans-Obturator Tape for the treatment of Female Stress Urinary Incontinence. Preliminary results on 140 cases

2004 The 2003 study continued and published with 12 month follow-up. Article below in French, and English translation of results. 
•Article in ENDOMAG Juin 2004
- The Trans-Obturator Tape for the treatment of Female Stress Urinary Incontinence. Results on 140 cases one year after.
- click here for English translation of the 1 year results in the ENDOMAG article and of the conclusion

2005
• European Urology 47 (2005) 102-107
- Sub-urethral tape treatment of female urinary incontinence – morbidity assessment of the trans-obturator route and a new tape (I-STOP®): a multi-centre experiment involving 604 cases.  Krauth et al European Urology 47 (2005) 102-107.

2006

 • European Urology 49 (2006) 133-138
- Peri-Operative complications and pain after the suburethral sling procedure for urinary stress incontinence: a French prospective randomised multicentre study comparing the retropubic and transobturator routes.  David-Montefiore et al European Urology 49 (2006) 133-138.
2009 
                                                                                                                   
                                                           
• I-STOP suburethral sling: Less deformation improves outcomes for Intrinsic Sphincteric Deficiency
-Beatriz ARIAS, G.W. Davila, Cleveland Clinic Florida

• Poster presented at AUGS 2009.
Slings for ISD-associated stress incontinence: Does elasticity or urethral positioning matter?Lefevre, T Peterson, Davila, Cleveland Cinic Florida. 

                                                           
2010
I-STOP Suburethral Sling: Outcomes of a Non-Deformable Sling for Intrinsic Sphincter Deficiency   Karp et al
     Journal of Minimally Invasive Gynecology 17 (2010) S1-S24


                                                           
2011 
 •   Four-year functional results of the suburethral sling procedure for stress urinary incontinence: a French prospective randomized multicentre study comparing the retropubic and transobturator routes
- M. Ballister, C. Bui, J-L Frobert, M Grisard-Anaf, J. Lienhart, H Fernandez, E David-Montefiore, R Rouzier, E Darai World J Urol DOI 10.1007/s00345-011-0668-1
                                                              

The IS-9 kit contains needles for both routes, TOT (Helical needle) and TVT, so only one kit is needed in a Theatre where surgeons want a choice of both routes.

The IS-1 kit contains needles for both routes, TOT ("C" shaped needle) and TVT, so only one kit is needed in a Theatre where surgeons want a choice of both routes.

The IS-6 kit contains needles for the TOT inside-out approach only.


FULL CATALOGUE
                                                           
 
   

 
• Further clinical trials are currently underway in France, UK, and USA.

• To arrange for training with an I-STOP user contact              Genesis Medical

 

 
  

 

I-STOP TOMS for male stress incontinence

 

  
  

 

 

                                           

 
   

 

 
 






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