Introduction: A new artificial anal sphincter, SphinKeeper(TM), was devised with the aim to treat fecal incontinence (FI) by implanting specifically designed self-expandable prostheses into the intersphincteric space. Preliminary data concerning the procedure feasibility and prosthesis localization at 3 months are presented.
Methods: SphinKeeper(TM) prostheses in the native state are dehydrated, thin, solid cylinder (length 29 mm, diameter 3 mm), changing their state (shorter--length 23 mm, thicker--diameter 7 mm--and softer, with shape memory) within 48 h of contact with fluids. In this study, 10 prostheses were implanted in each patient with FI under local anesthesia and under endoanal ultrasound (EAUS) guidance, into the upper-middle intersphincteric space of the anal canal by a specifically designed delivery system. EAUS was used postoperatively to assess prostheses dislocation.
Results: Ten patients (5 females; median age 58 years, range 20-75) were enrolled and treated with SphinKeeper(TM) implantation. Median duration of procedure (performed by endoanal ultrasound guidance) was 40 min (range 30-45). Neither intraoperative nor postoperative complications were reported after a 3-month follow-up. In one patient, a partial dislocation of a single prosthesis was documented by EAUS, causing anal discomfort which resolved after 1 week.
Conclusion: SphinKeeper(TM) can be safely implanted in patients with FI of different etiology. Implantation was well tolerated with no dislodgment of implants at 3-month follow-up.
Keywords: Artificial anal sphincter; Bulking agents; Dynamic graciloplasty; Fecal incontinence; Gatekeeper; Sacral nerve stimulation; Sphincter lesion; Sphincteroplasty.