Sphinkeeper Procedure for Treating Severe Faecal Incontinence—A Prospective Cohort Study

Abstract

(1) Background: The Sphinkeeper implantation for faecal incontinence (FI) is a novel surgical procedure with limited data on its clinical efficacy. Therefore, we aimed to assess the functional outcome following Sphinkeeper surgery in patients with refractory FI. (2) Methods: Between 2018 and 2020, eleven consecutive patients (9 female) with FI met the inclusion criteria and were enrolled for surgery. Functional outcome and quality of life were evaluated by standard questionnaires pre- and post-surgery. Migration of protheses was demonstrated by 3D endoanal ultrasound. The median follow-up time was eight months (range 3–18 months). (3) Results: The median age was 75 years (range 46–89 years) with a median BMI of 27.4 (range 21.2–30.1). The median number of implanted prostheses per intervention was nine (range 9–10). We found no intraoperative or early postoperative complications. After two months, two prostheses in one patient had to be removed due to pain at the perianal skin site. The median St. Mark’s incontinence score decreased significantly from 22 to 13 points (p = 0.008). The SF-12 showed a significant improvement (35.9 versus 46.3) after surgery (p = 0.028). A migration of at least one prosthesis was observed in ten patients (91%). Six (60%) prostheses were found at the same level in another ten patients. (4) Conclusion: Sphinkeeper implantation is a promising surgical technique for patients with severe FI. The complication rate is low, and short-term functional improvement can be achieved even in severe forms of FI. Migration of implants commonly occurs.

Clinical effectiveness and safety of self-expandable implantable bulking agents for faecal incontinence: a systematic review

“…Of those, seven studies were single-centred [ 7 , 12 , 17 , 26 , 35 ], and one trial was conducted at multiple centres [ 10 ]. All studies, except three (Spain [ 12 ], Austria [ 36 ], Australia [ 37 ]), were conducted in Italy. They were carried out between 2011 [ 10 ] and 2022 [ 7 , 26 , 37 ].…”

“…They were carried out between 2011 [ 10 ] and 2022 [ 7 , 26 , 37 ]. The sponsor was not reported [ 7 , 10 , 12 , 17 , 36 , 37 ], or it was declared that there was no commercial sponsor.…”

“…The individual patients were treated with four to six Gatekeeper™ prostheses [ 10 , 12 , 35 ] or nine to ten Sphinkeeper™ prostheses [ 7 , 17 , 26 ]. The age of patients ranged from 20 [ 17 ] to 89 [ 36 ] years. The assessed indications were passive FI [ 12 , 35 ], passive, urge, or mixed FI [ 17 ], refractory FI [ 36 ], and four trials did not specify the form of FI [ 7 , 10 , 26 , 37 ].…”

“…The age of patients ranged from 20 [ 17 ] to 89 [ 36 ] years. The assessed indications were passive FI [ 12 , 35 ], passive, urge, or mixed FI [ 17 ], refractory FI [ 36 ], and four trials did not specify the form of FI [ 7 , 10 , 26 , 37 ]. All studies, except two [ 7 , 17 ], analysed short-term effectiveness and sustainability for more than six months, i.e., durability of implantable bulking agents' effects.…”

“…All studies, except two [ 7 , 17 ], analysed short-term effectiveness and sustainability for more than six months, i.e., durability of implantable bulking agents' effects. One study only assessed sustainability (8 months FU) [ 36 ]. The number of patients per study at baseline ranged from seven [ 12 ] to 54 [ 10 ], and the FU period ranged from one [ 10 , 12 , 26 , 35 ] to 36 [ 35 ] months.…”