Efficacy of Sphinkeeper™ implant in treating faecal incontinence.
Ontology highlight
ABSTRACT:
SUBMITTER: Litta F
PROVIDER: S-EPMC7154545 | biostudies-literature | 2020 Apr
REPOSITORIES: biostudies-literature
Publications
Efficacy of Sphinkeeper™ implant in treating faecal incontinence.
Litta F F Parello A A De Simone V V Campennì P P Orefice R R Marra A A AA Goglia M M Moroni R R Ratto C C
The British journal of surgery 20200217 5
The primary aim of this prospective study was to assess the efficacy of Sphinkeeper™ (SK) implantation in patients with faecal incontinence. Forty-two patients with faecal incontinence (14 with sphincter defects) underwent SK implantation and were followed up for a mean(s.d.) of 15·9(8·6) months. SK implantation was a safe and effective method that improved patients' quality of life. Implants and incontinence. ...[more]
Similar Datasets
Project description:(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.
| S-EPMC8584920 | biostudies-literature
Project description: Not available
| S-EPMC7203602 | biostudies-literature
Project description:BACKGROUND: Existing scales for assessing faecal incontinence have not been validated against clinical assessment, or with regard to reproducibility. They also fail to take into account faecal urgency, and the use of antidiarrhoeal medications. AIMS: To establish the validity, and sensitivity to change, of existing scales and a newly designed incontinence scale. METHODS: (1) Twenty three patients (21 females, median age 57 years) were prospectively evaluated by two independent clinical observers, using three established scales (Pescatori, Wexner, American Medical Systems), a newly devised scale which also includes details about urgency and antidiarrhoeal drugs, and by a 28 day diary. (2) A further 10 female patients were assessed by the same scales before and after surgery for faecal incontinence. RESULTS: (1) Assessments by two independent clinicians correlated well. All four scales and a diary card correlated highly and significantly with the clinical impression, with the new scale reaching the highest correlation (r=0.79, p<0.001). (2) All except one score changed significantly in response to surgical treatment; the new scale showed the greatest change, at the highest level of significance (p=0.004), and correlated best with the clinicians' assessment of change (r=0.94, p<0.001). CONCLUSIONS: Existing scales for the assessment of faecal incontinence correlate well with careful clinical impression of severity, and serve as useful and reproducible measures for comparison of patients and treatments. A newly devised scale has shown high clinical validity and utility.
| S-EPMC1760067 | biostudies-other
Project description:BackgroundThe aim of the present study was to evaluate the long-term efficacy of percutaneous tibial nerve stimulation (PTNS) for patients with faecal incontinence (FI) refractory to conservative treatment. Secondary aims were to identify predictors of response and validate new treatment pathways for partial responders.MethodsA prospective, interventional study was carried out in a specialist defecatory disorder unit from a university hospital between January 2010 and June 2017 on patients > 18 years old with FI refractory to conservative treatment. Thirty-minute PTNS sessions were performed in three phases (weekly, biweekly and monthly) up to a year, with clinical reassessment at 3, 6, 12 and 36 months. Patients were classified as optimal responders when their pretreatment Wexner score decreased > 50%; partial responders when it decreased 25-50%; and insufficient responders if it decreased < 25%. Only optimal and partial responders progressed into successive phases.ResultsBetween 2010 and 2017, 139 patients (110 women, median age 63 years [range 22-82 years]) were recruited. After the first phase, 4 patients were optimal responders, 93 were partial responders and 36 were insufficient responders. At 6 and 12 months, 66 and 89 patients respectively were optimal responders, with an optimal response rate of 64% at the end of treatment. A total of 93.3% patients with a partial response initially finally became optimal responders. Furthermore, at 36 months, 71.9% of patients were still optimal responders without supplementary treatment, although their quality of life did not improve significantly. Baseline Wexner scores ≤ 10 and symptom duration < 1 year were identified as predictive factors for positive responses to PTNS.ConclusionsPatients undergoing PTNS for 1 year following this protocol had optimal long-term responses. PTNS sessions for up to 1 year in patients who were partial responders prevents a high percentage of them from needing more invasive treatments, and maintains long-term continence in patients who were optimal responders.
| S-EPMC10169891 | biostudies-literature
Project description:AimAn increase in intestinal gas production due to small intestinal bowel overgrowth (SIBO) is a contributing factor for flatus incontinence. The aims of our study were to assess the efficacy of metronidazole in a select population of patients with flatus incontinence associated with SIBO and to compare its efficacy with that of a combination of simethicone and activated charcoal (SC; Carbosylane) in randomized experimental arms.MethodsAdult patients suffering from flatus incontinence associated with SIBO diagnosed by a glucose breath test were enrolled in the study. They were given metronidazole or Carbosylane (SC) for 10 days. The reduction in the mean daily number of gas leakages reported in a 3-day diary before and at the end of the treatment was used as the primary endpoint.ResultsOf 52 consecutive subjects with flatus incontinence, 23 (44%) had SIBO, 16 (33%) of whom were included in and completed the study. The relative reduction in flatus incontinence episodes was significantly higher in the metronidazole than in the SC group (66.8±34.8% vs. 25±50%, P = 0.03), decreasing by more than 50% in 7 (87.5%) of the subjects in the metronidazole group compared with only 1 (12.5%) in the SC group (odds ratio 1.9, 95% confidence interval 0.9-56.9, P = 0.06).ConclusionOur results show a promising trend indicating that metronidazole might significantly improve flatus incontinence associated with SIBO and might be more successful in treating flatus incontinence than gas absorbents.
| S-EPMC5538639 | biostudies-literature
Project description:Faecal incontinence (FI) is a substantial health problem with a prevalence of approximately 8% in community-dwelling populations. Sacral neuromodulation (SNM) is considered the first-line surgical treatment option in adults with FI in whom conservative therapies have failed. The clinical efficacy of SNM has never been rigorously determined in a trial setting and the underlying mechanism of action remains unclear.The design encompasses a multicentre, randomised, double-blind crossover trial and cohort follow-up study. Ninety participants will be randomised to one of two groups (SNM/SHAM or SHAM/SNM) in an allocation ratio of 1:1. The main inclusion criteria will be adults aged 18-75 years meeting Rome III and ICI definitions of FI, who have failed non-surgical treatments to the UK standard, who have a minimum of eight FI episodes in a 4-week screening period, and who are clinically suitable for SNM. The primary objective is to estimate the clinical efficacy of sub-sensory SNM vs. SHAM at 32 weeks based on the primary outcome of frequency of FI episodes using a 4-week paper diary, using mixed Poisson regression analysis on the intention-to-treat principle. The study is powered (0.9) to detect a 30% reduction in frequency of FI episodes between sub-sensory SNM and SHAM stimulation over a 32-week crossover period. Secondary objectives include: measurement of established and new clinical outcomes after 1 year of therapy using new (2017 published) optimised therapy (with standardised SNM-lead placement); validation of new electronic outcome measures (events) and a device to record them, and identification of potential biological effects of SNM on underlying anorectal afferent neuronal pathophysiology (hypothesis: SNM leads to increased frequency of perceived transient anal sphincter relaxations; improved conscious sensation of defaecatory urge and cortical/subcortical changes in afferent responses to anorectal electrical stimulation (main techniques: high-resolution anorectal manometry and magnetoencephalography).This trial will determine clinical effect size for sub-sensory chronic electrical stimulation of the sacral innervation. It will provide experimental evidence of modifiable afferent neurophysiology that may aid future patient selection as well as a basic understanding of the pathophysiology of FI.International Standard Randomised Controlled Trial Number: ISRCTN98760715 . Registered on 15 September 2017.
| S-EPMC6019783 | biostudies-other
Project description:BACKGROUND AND AIMS: Faecal incontinence (FI) is a socially devastating problem. The treatment algorithm depends on the aetiology of the problem. Large anal sphincter defects can be treated by sphincter replacement procedures: the dynamic graciloplasty and the artificial bowel sphincter (ABS). MATERIALS AND METHODS: Patients were included between 1997 and 2006. A full preoperative workup was mandatory for all patients. During the follow-up, the Williams incontinence score was used to classify the symptoms, and anal manometry was performed. RESULTS: Thirty-four patients (25 women) were included, of which, 33 patients received an ABS. The mean follow-up was 17.4 (0.8-106.3) months. The Williams score improved significantly after placement of the ABS (p<0.0001). The postoperative anal resting pressure with an empty cuff was not altered (p=0.89). The postoperative ABS pressure was significantly higher then the baseline squeeze pressure (p=0.003). Seven patients had an infection necessitating explantation. One patient was successfully reimplanted. CONCLUSION: The artificial bowel sphincter is an effective treatment for FI in patients with a large anal sphincter defect. Infectious complications are the largest threat necessitating explantation of the device.
| S-EPMC2077921 | biostudies-other
Project description: Not available
| S-EPMC6355973 | biostudies-literature
Project description:BACKGROUND: Colonic motor function has not been studied in the ambulatory setting over a prolonged period in the unprepared state. Furthermore, the disturbance of this function in patients with faecal incontinence is unknown. AIM: To study colonic function over two to three days in the ambulatory, unprepared state in health and in patients with idiopathic faecal incontinence. METHODS: Six healthy women and six women with faecal incontinence and a structurally intact anal sphincter ingested a dual radioisotope meal, and had a six sensor, solid state manometric probe colonoscopically inserted into the left colon. Scanning was performed until radioisotope left the gut and pressure was recorded for a median of 44 hours. RESULTS: Three of six patients showed abnormal gastric emptying. Patients showed no disturbance of colonic radioisotope transit. Controls had a median of 12, whereas patients had a median of 16, high amplitude propagated waves per 24 hours. In three patients urge incontinence was associated with high amplitude (up to 500 cm water) propagated waves which often reached the rectum. These high pressure waves were identical to those occurring in healthy subjects, the only difference being the lack of adequate sphincter response. Passive incontinence was not associated with colonic motor activity. Defaecation in all subjects was associated with identical propagated waves, and distal movement of 13% (median) of right colonic content and excretion of 32% from the left colon and rectum. The urge to defaecate was associated with either propagated waves (45%) or non-propagated contractions (55%). Rectal motor complexes were recorded in both groups of subjects, but similar rhythmic activity was also recorded in the sigmoid and descending colon. CONCLUSIONS: Normal colonic function consists of frequent high pressure propagated waves. Rhythmic activity occurs both proximal to and in the rectum. Defaecation is characterised by high pressure propagated waves associated with coordinated anal sphincter relaxation. Patients with faecal incontinence may have a widespread disturbance of gut function. Urge incontinence, an urge to defaecate, and defaecation can all be associated with identical high amplitude propagated pressure waves.
| S-EPMC1891481 | biostudies-other
Project description:IntroductionObesity increases the risk of pelvic floor disorders in individuals with obesity, including faecal incontinence. Faecal incontinence (FI) is a condition with important clinical and psychosocial consequences. Though it is associated with obesity, the effect of bariatric surgery on the prevalence and severity of FI is not well reported.ObjectiveTo assess the effect of bariatric surgery on the prevalence and severity of FI in adult patients with obesity.MethodsThis systematic review was conducted in accordance with the PRISMA statement. Two independent reviewers performed a literature search in MEDLINE, PubMed, Cochrane and Embase from 1 January 1980 to 12 January 2019. We included published English-language randomized control trials and observational studies assessing pre- and post-bariatric surgery prevalence or severity of FI. Random-effects models with DerSimonian and Laird's variance estimator were used for meta-analysis.ResultsThirteen studies were included, eight assessing prevalence (678 patients) and 11 assessing severity of FI (992 patients). There was no significant difference in prevalence post-operatively overall, though it trended towards a reduction [pooled OR=0.55; =0.075]. There was a significant reduction of FI prevalence in women post-bariatric surgery [95% CI 0.22 to 0.94, p=0.034]. There was a statistically significant reduction in FI prevalence following Roux-en-Y gastric bypass and one anastomosis gastric bypass [0.46, 95% CI 0.26 to 0.81; p=0.007]. There was no significant reduction of incontinence episodes post-operatively [pooled mean difference =-0.17, 95% CI -0.90 to 0.56; p=0.65]. Quality of life (QOL) was not significantly improved post-bariatric surgery [mean differences for the following facets of QOL: behaviour -0.35, 95% CI -0.94 to 0.24; depression 0.04, 95% CI -0.12 to 0.2; lifestyle -0.33, 95% CI -0.98 to 0.33; p values of 0.25, 0.61 and 0.33, respectively].DiscussionThere was a significant reduction in FI prevalence in women and those who underwent Roux-en-Y or one anastomosis gastric bypass. Our results for FI prevalence overall, FI severity and impact on quality of life were not statistically significant. Larger studies are needed in this under-researched area to determine the true effect of bariatric surgery on FI.
| S-EPMC8175321 | biostudies-literature