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Tension Free Tape for Stress Urinary Incontinence

 
 
 
 
   
   
Davila Procedure
for ISD - Video
   
   
   
 

 

I-STOP®  for female Stress Urinary Incontinence

 

 

  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. 

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.

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.

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. Other tapes show over 1% erosion rates. I-STOP is truly different.
                                                                                  Clinical papers
 

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 mark and FDA approved.

Clinical results in numerous papers covering more 1287 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 :• Transobturator Outside-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 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.
-
English translation of the 1 year results in the ENDOMAG article
 
and of the conclusion

2005
European Urology 47 (2005) 102-107
- Krauth et Coll. 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. European Urology 47 (2005) 102-107.

2006

 • European Urology 49 (2006) 133-138
-
David-Montefiore et Coll. 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.European Urology 49 (2006) 133-138.
2009
• Poster presented at IUGA 2009.
Comparison of Non-elastic slings for ISD-Associated Stress Urinary Incontinence.Lefevre, Jean-Michel, Davila, Cleveland Cinic Florida. 


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. 



.  

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

   USA


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

• Product leaflet
 
 
 

I-STOP TOMS for male stress incontinence