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The AdVance™ XP Male Sling System is intended for the placement of a suburethral sling for the treatment of male stress urinary incontinence (SUI). These devices are contraindicated for patients with urinary tract infections, blood coagulation disorders, a compromised immune system, or any other condition that would compromise healing, with renal insufficiency, and upper urinary tract relative obstruction. Proper patient evaluation, selection, and counseling of realistic expectations should occur.
A six-month period of non-invasive treatment (e.g., behavior modification, bladder exercises, biofeedback, extra corporeal magnetic stimulation of the pelvic floor, or drug therapy) is recommended before a sling implant is considered for males with stress urinary incontinence. Possible adverse events include, but are not limited to, acute inflammatory tissue reaction and transitory local irritation, which has been reported with the use of the absorbable suture.
Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, and potential adverse events.