A prospective trial of the THD SphinKeeper® for faecal incontinence

Colbran, Rachel; Gillespie, Christopher; Warwick, Andrea

doi:10.1111/codi.16037

Cited by 5 publications

(18 citation statements)

References 11 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…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 ].…”

Section: Resultsmentioning

confidence: 99%

“…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 ]. The sponsor was not reported [ 7 , 10 , 12 , 17 , 36 , 37 ], or it was declared that there was no commercial sponsor.…”

Section: Resultsmentioning

confidence: 99%

“…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.…”

Section: Resultsmentioning

confidence: 99%

“…Among these eight studies, 173 patients were enrolled, and 166 of them were analysed. Losses to follow-up (FU) were reported in two studies (n = 7) [ 26 , 37 ]. Eighty-one patients received Gatekeeper™ implants, and 85 patients received Sphinkeeper™ prostheses.…”

Section: Resultsmentioning

confidence: 99%

“…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.…”

Section: Resultsmentioning

confidence: 99%

See 4 more Smart Citations

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

2022

View full text Add to dashboard Cite

Purpose The purpose of this systematic review is to evaluate whether self-expandable implantable vs non-self-expandable injectable bulking agents (second-line therapies) are equal/superior in terms of effectiveness (severity, quality of life [QoL]) and safety (adverse events) for faecal incontinence (FI). Methods A systematic review was conducted, and five databases were searched (Medline via Ovid, Embase, Cochrane Library, University of York Centre for Reviews and Dissemination, and International Network of Agencies for Health Technology database). In-/exclusion criteria were predefined according to the PICOS scheme. The Institute of Health Economics risk of bias (RoB) tool assessed studies' internal validity. According to the Grading of Recommendations, Assessment, Development and Evaluation approach, the strength of evidence for safety outcomes was rated. A qualitative synthesis of the evidence was used to analyse the data. Results The evidence consists of eight prospective single-arm, before-after studies (166 patients) fulfilling the inclusion criteria for assessing clinical effectiveness and safety of implantable bulking agents. FI severity statistically significantly improved in five of seven studies rated by the Cleveland Clinic FI Score and in three of five studies measured by the Vaizey score. Statistically significant improved disease-related QoL was found in one of five studies measured by the FI QoL Score and in one of two studies rated by the American Medical Systems score. Procedure-related adverse events occurred in 16 of 166 patients (i.e., intraoperative complications, anal discomfort and pain). Device-related adverse events occurred in 48 of 166 patients, including prostheses’ dislodgement and removed/extruded prostheses. Studies were judged with moderate/high RoB. The strength of evidence for safety was judged to be very low. Conclusion Implantable bulking agents might be an effective and safe minimally invasive option in FI treatment if conservative therapies fail. FI severity significantly improved, however, effects on QoL need to be explored in further studies. Due to the uncontrolled nature of the case series, comparative studies need to be awaited.

show abstract

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

“…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.…”

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

See 3 more Smart Citations

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

2022

View full text Add to dashboard Cite

show abstract

Long-term outcome after SphinKeeper® surgery for treating fecal incontinence—who are good candidates?

Dawoud,

Widmann,

Pereyra

et al. 2023

Langenbecks Arch Surg

View full text Add to dashboard Cite

Purpose The efficacy of the novel SphinKeeper® procedure for the treatment of fecal incontinence (FI) is not yet well defined. This study aimed to assess long-term functional outcomes after SphinKeeper® surgery. Methods We included 32 patients with FI (28 female), who were operated at a tertiary referral center between August 2018 and September 2021. Functional outcome and quality of life were evaluated prospectively using validated questionnaires before and after surgery. Additionally, endoanal ultrasound and anal manometry were conducted prior and after SphinKeeper® implantation. Predictive parameters for treatment success were defined. Results The mean follow-up time was 22.62 ± 8.82 months. The St. Mark’s incontinence score decreased significantly after surgery (median preoperative = 19 (IQR 17–22) versus median last follow-up = 12 (IQR 8–16), p = 0.001). Similarly, physical short-form health survey showed a significant improvement after SphinKeeper® implantation (p = 0.011). Patients with a higher degree of internal sphincter defect showed an improved objective therapy success (r = 0.633, p = 0.015) after SphinKeeper® operation, whereas the type and severity of FI had no impact on the functional outcome. Notably, a higher number of dislocated prostheses (r = 0.772, p = 0.015) showed a significant correlation with reduced improvement of incontinence. Conclusion The SphinKeeper® procedure showed a significant long-term functional improvement in over half of the patients. Patients with a higher internal sphincter defect benefited most, whereas dislocation of the prostheses was associated with less favorable results.

show abstract

Endosonographic monitoring of Sphinkeeper® prostheses movements: does physical activity have an impact?

Dawoud,

Gidl,

Widmann

et al. 2023

Updates Surg

View full text Add to dashboard Cite

The Sphinkeeper® procedure for treating faecal incontinence (FI) may be associated with potential implant migration (IM) and dislocation (ID), with considerable variations regarding their occurrence and effects on consecutive functional outcome. This study assessed IM and ID following the Sphinkeeper® procedure and its correlation with physical activity. This was a prospective observational clinical study of ten patients undergoing Sphinkeeper® operation due to FI between August 2020 and November 2020 at the Medical University of Vienna. Patients were followed-up after 1, 2, 3 and 6 months and 1 year postoperatively. Each follow-up visit included endosonographic monitoring of protheses location and manometric examinations. Additionally, functional outcome and physical activity were assessed using validated standardized questionnaires. The median number of prostheses implanted was 10 (IQR 9–10). The St. Mark’s incontinence (SMS) score improved significantly until the last follow-up (p = 0.049), without observing a significant effect on the physical SF-12 score. The median rate of implants leading to IM and ID was 3 (range 1–4) and 2 (range 1–2) after 3 months of follow-up. A strong association of deltaSMS with number of dislocated prostheses at one month after Sphinkeeper® implantation was observed (r = 0.654, p = 0.078). Physical activity, assessed by the international physical activity questionnaire, did not have an impact on the correct prosthesis placement (1 month: p = 0.527; 2 months: p = 0.886; 3 months: p = 0.180; 6 months: p = 0.111). IM and ID of Sphinkeeper® prostheses occurred frequently early after surgery and affected functional outcome negatively. Physical activity did not have an influence on the implants displacement.

show abstract

A prospective trial of the THD SphinKeeper® for faecal incontinence

Cited by 5 publications

References 11 publications

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

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

Long-term outcome after SphinKeeper® surgery for treating fecal incontinence—who are good candidates?

Endosonographic monitoring of Sphinkeeper® prostheses movements: does physical activity have an impact?

Contact Info

Product

Resources

About