Safyre™: A Readjustable Minimally Invasive Sling For Female Urinary Stress Incontinence

Introduction: SAFYRE™ is a readjustable and minimally invasive sling for the treatment of stress urinary incontinence (SUI). It is as a pubovaginal sling placed in the medial third of the urethra. The initial experience is described. Materials and Methods: Forty-five patients (mean age = 59 years) underwent a SAFYRE™ implant to treat SUI. Physical examination and urodynamic study were performed before surgery. All patients presented symptoms of SUI and 20% also reported mild urgency. Approximately 60% of this group had a previously failed anti-incontinence procedure. Urethral hypermobility was diagnosed in 40% of the patients and intrinsic sphincter deficiency (ISD) in 60% of the cases. Results: The average follow up period was 10 months. The mean operative time was 20 minutes. Dystopia repair was performed whenever necessary, during the same procedure. The average hospital stay was 24 hours. In 11% of the implants, bladder perforation occurred. During the postoperative period, 9 patients (20%) developed transient urgency symptoms. During the initial follow up period, 90% were found to be continent, 3% reported an improvement and 7% were unchanged. Conclusion: SAFYRE™ is a safe and quick procedure that allows postoperative readjustment. This technique may be an attractive alternative in the management of SUI, should the good result obtained so far prove to be long lasting.294353359Norris, J.P., Breslin, D.S., Staskin, D.R., Use of synthetic material in sling surgery: A minimally invasive approach (1996) J. Endourol., 10, pp. 227-230Palma, P.C.R., Ikari, O., D'Ancona, C.A.L., Netto N.R., Jr., Alça pubovaginal sintética no tratamento da incontinência urinária de esforço (1992) J. Bras. Urol., 18, pp. 202-204. , [in Portuguese]Ulmsten, U., Henriksson, L., Johnson, P., Varhos, G., An ambulatory surgical procedure under local anesthesia for treatment of female urinary incontinence (1996) Int. Urogynecol. J., 7, pp. 81-86Petros, P., Ulmsten, U., An integral theory and its method for the diagnosis and management of female urinary incontinence (1993) Scand. J. Urol. Nephrol., 153, pp. 1-93Blaivas, J.G., Jacobs, B.Z., Pubovaginal fascial sling for the treatment of complicated stress urinary incontinence (1991) J. Urol., 145, pp. 1214-1218Blaivas, J.G., Olsson, C.A., Stress incontinence: Classification and surgical approach (1988) J. Urol., 139, pp. 727-730McGuire, E.J., Fitzpatrick, C.C., Wan, J., Bloom, D., Sanvor-Denker, J., Rithey, M., Clinical assesment of urethral sphincter function (1993) J. Urol., 150, pp. 1452-1454Schrepferman, C.G., Griebling, T.L., Nygaard, I.E., Kreder, K.J., Resolution of urge symptoms following sling cystourethropexy (2000) J. Urol., 164, pp. 1628-1631Kaplan, S.A., Te, A.E., Young, G.P., Prospective analysis of 373 consecutive women with stress urinary incontinence treated with a vaginal wall sling the Columbia-Cornell University experience (2000) J. Urol., 164, pp. 1623-1628Ulmstem, U., Falconer, C., Johnson, P., Jomaa, M., Lannér, L., Nilsson, C.G., A multicenter study of tension-free vaginal tape (TVT) for surgical treatment of stress urinary incontinence (1998) Int. Urogynecol. J., 9, pp. 210-213Carlin, B.I., Klutke, J.J., Klutke, C.G., The tension-free vaginal tape procedure for the treatment of stress incontinence in the female patient (2000) Urology, 55 (SUPPL. 6), pp. 28-31Klutke, J.J., Carlin, B.I., Klutke, C.G., The tension-free vaginal procedure: Correction of stress incontinence with minimal alteration in proximal urethral mobility (2000) Urology, 55, pp. 512-514Palma, P.C.R., Riccetto, C.L.Z., Dambros, M., Thiel, M., Herrmann, V., Netto N.R., Jr., Safyre sling: Early results of a new tension-adjustable and self-anchoring device for female stress incontinence (2002) J. Endourol., 16 (SUPPL. 1). , Abst P25-