cdr

Published Clinical Studies

The inFlow’s safety and effectiveness have been established by seven clinical studies published in major peer-reviewed journals (total n=501), including the pivotal trial that was the primary basis for FDA approval of the inFlow and six investigator-sponsored studies, three of which were long-term studies of between one and three years. For a review of these and other inFlow studies, please see inFlow Clinical Review.

The FDA has published its 2014 review of the inFlow and its pivotal trial. Please see FDA Report DEN130044.

The inFlow is also featured in a newly published and highly recommended textbook, The Underactive Bladder (Springer, 2016), edited by Drs. Michael Chancellor and Ananias Diokno. Please see http://www.springer.com/us/book/9783319236865


control

  1. Chen TYH, Ponsot Y, Carmel M, Bouffard N, Kennelly MJ, Tu LM. Multi-Centre Study of Intraurethral Valve-Pump Catheter in Women with a Hypotonic or Acontractile Bladder. Eur Urol 2005; 48: 628–633.
  2. Mazouni C; Karsenty G; Bladou F; Serment G. Urethral device in women with chronic urinary retention: an alternative to self-catheterization? Eur J Obstet Gynecol Reprod Biol 2004; 115(1): 80-84
  3. Lynch WJ, Testa GA, Bell D: A Study to Determine Subjective and Objective Benefits of a Remote-Controlled Intra-Urethral Device for the Management of Female Acontractile Bladder. Brit J Urol 2003; 92: 960-963.
  4. Madjar S, Halachmi S, Wald M, Issaq E, Moskovitz B, Beyar M, Nativ O: Long-term follow-up of the inFlow™ intraurethral insert for the treatment of women with voiding dysfunction. Eur Urol 2000; 38:161-166.
  5. Madjar S, Sabo E, Halachmi S, Wald M, Issaq E, Moskovitz B, Beyar M, Nativ O: A remote controlled intraurethral insert for artificial voiding - A new concept for treating women with voiding dysfunction. J Urol 1999; 161:895-898.
  6. Schurch S, Suter S, Dubs M: Intraurethral sphincter prosthesis to treat hyporeflexic bladders in women – Does it work? Brit J Urol 1999; 84:789-794.
  7. Nativ O, Moskovitz B, Issaq E, Condrea A, Kastin A, Halachmi S, Burbara J, Madjar S, Beyar M: A new intraurethral sphincter prosthesis with a self-contained urinary pump. ASAIO J 1997; 43:197-203.