Aim

THD SphinKeeper®is an emerging surgical technique for faecal incontinence (FI). The safety, indications and efficacy of the procedure are still being investigated. This study presents the first experience of SphinKeeper® in Australia.

Method

This was a prospective single centre observational study of patients undergoing SphinKeeper® implantation between February 2018 and September 2019. Baseline demographics, intra-operative and post-operative complications, Cleveland Clinic Faecal Incontinence Score, St Mark’s Incontinence Score, Faecal Incontinence Quality of Life score (FIQOL), anorectal manometry and endo-anal ultrasound were assessed preoperatively, three and 12-months post implantation.

Results

Thirteen patients (2 male, 11 female) underwent implantation during the study period. Anal sphincter defects were present in 13 (76.9%) patients (external anal sphincter (EAS) defect: 2 (15.4%); internal anal sphincter (IAS) defect 4 (30.8%); EAS + IAS defect: 4 (30.8%). Median follow up was 32 months (range: 18 – 37 months). There were four complications: one intra-operative (rectal perforation), and three post operative (one implant extrusion; two implants that required removal due to malposition). At 12 months, an average of 9/10 implants remained ideally placed in each patient. THD SphinKeeper® insertion was associated with an improvement in coping / behaviour as measured using FIQOL (P=0.047). However the procedure did not improve FI scores or ano-rectal manometry parameters.

Conclusion

In this study, SphinKeeper® marginally improved faecal incontinence symptoms but there was no significant impact on anorectal manometric measurements. Larger scale studies are needed to determine the patient cohort most likely to benefit from this procedure.