The artificial bowel sphincter for faecal incontinence: a single centre study.
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ABSTRACT:
SUBMITTER: Melenhorst J
PROVIDER: S-EPMC2077921 | biostudies-other | 2008 Jan
REPOSITORIES: biostudies-other
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Project description:Artificial bowel sphincters (ABS), specifically the Acticon Neosphincter, have been used to treat fecal incontinence (FI) since the early 2000s. This report and literature review focuses on possible device malfunctions of previously placed ABS for FI. We present a case of device malfunction in a patient with FI who had a previously placed ABS, review relevant literature, and discuss outcomes of ABS placement with possible device malfunctions.
| S-EPMC6199762 | biostudies-literature
Project description:BackgroundIn an earlier pilot study with 10 women, we investigated a new approach for therapy of faecal incontinence (FI) due to obstetric trauma, involving ultrasound-guided injection of autologous skeletal muscle-derived cells (SMDC) into the external anal sphincter (EAS), and observed significant improvement. In the current study, we tested this therapeutic approach in an extended patient group: male and female patients suffering from FI due to EAS damage and/or atrophy. Furthermore, feasibility of lower cell counts and cryo-preserved SMDC was assessed.MethodsIn this single-centre, explorative, baseline-controlled clinical trial, each patient (n = 39; mean age 60.6 ± 13.81 years) received 79.4 ± 22.5 × 106 cryo-preserved autologous SMDC. Changes in FI parameters, Fecal Incontinence Quality of Life (FIQL), anorectal manometry and safety from baseline to 1, 6 and 12 months post implantation were evaluated.ResultsSMDC used in this trial contained a high percentage of myogenic-expressing (CD56+) and muscle stem cell marker-expressing (Pax7+, Myf5+) cells. Intervention was well tolerated without any serious adverse events. After 12 months, the number of weekly incontinence episodes (WIE, primary variable), FIQL and patient condition had improved significantly. In 80.6% of males and 78.4% of females, the WIE frequency decreased by at least 50%; Wexner scores and severity of FI complaints decreased significantly, independent of gender and cause of FI.ConclusionsInjection of SMDCs into the EAS effectively improved sphincter-related FI due to EAS damage and/or atrophy in males and females. When confirmed in a larger, placebo-controlled trial, this minimal invasive procedure has the potential to become first-line therapy for FI.Trial registrationEU Clinical Trials Register, EudraCT 2010-023826-19 (Date of registration: 08.11.2010).
| S-EPMC6136163 | biostudies-literature
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: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:BackgroundStress urinary incontinence (SUI) is a frequent adverse effect for men undergoing prostate surgery. A large proportion (around 8% after radical prostatectomy and 2% after transurethral resection of prostate (TURP)) are left with severe disabling incontinence which adversely effects their quality of life and many are reliant on containment measures such as pads (27% and 6% respectively). Surgery is currently the only option for active management of the problem. The overwhelming majority of surgeries for persistent bothersome SUI involve artificial urinary sphincter (AUS) insertion. However, this is expensive, and necessitates manipulation of a pump to enable voiding. More recently, an alternative to AUS has been developed - a synthetic sling for men which elevates the urethra, thus treating SUI. This is thought, by some, to be less invasive, more acceptable and less expensive than AUS but clear evidence for this is lacking. The MASTER trial aims to determine whether the male synthetic sling is non-inferior to implantation of the AUS for men who have SUI after prostate surgery (for cancer or benign disease), judged primarily on clinical effectiveness but also considering relative harms and cost-effectiveness.Methods/designMen with urodynamic stress incontinence (USI) after prostate surgery, for whom surgery is judged appropriate, are the target population. We aim to recruit men from secondary care urological centres in the UK NHS who carry out surgery for post-prostatectomy incontinence. Outcomes will be assessed by participant-completed questionnaires and 3-day urinary bladder diaries at baseline, 6, 12 and 24 months. The 24-h urinary pad test will be used at baseline as an objective assessment of urine loss. Clinical data will be completed at the time of surgery to provide details of the operative procedures, complications and resource use in hospital. At 12 months, men will also have a clinical review to evaluate the results of surgery (including another 24-h pad test) and to identify problems or need for further treatment.DiscussionA robust examination of the comparative effectiveness of the male synthetic sling will provide high-quality evidence to determine whether or not it should be adopted widely in the NHS.Trial registrationInternational Standard Randomised Controlled Trial Registry: Number ISRCTN49212975 . Registered on 22 July 2013. First patient randomised on 29 January 2014.
| S-EPMC5822657 | biostudies-literature
Project description:IntroductionIncidence of inflammatory bowel disease (IBD) is increasing in childhood and treatment increasingly targets mucosal healing. Monitoring bowel inflammation requires endoscopy or MRI enterography which are invasive, expensive and have long waiting lists.We aim to examine the feasibility of a non-invasive monitoring tool-bowel ultrasound (BUS)-in children with IBD and explore correlations with inflammatory markers and disease activity measures. Some BUS criteria have been found to correlate with these markers; however, this has not been validated in children.We aim to examine the feasibility of BUS for monitoring inflammation in this population; highlighting useful parameters for this purpose. We aim to inform a larger scale randomised controlled trial using BUS.Methods and analysisThis prospective observational feasibility study will be carried out over 24 months at the Noah's Ark Children's Hospital for Wales, Cardiff; with the endpoint recruitment of 50 participants. Children aged 2-18 years with a modified Porto criteria diagnosis of IBD will be included.Patients without IBD or who have previously undergone IBD-related surgery will be excluded; as will families unable to give informed consent.Ultrasound scan images and reports will be collected, as well as laboratory results and clinical outcomes.The primary aim will assess the feasibility of targeted BUS for disease monitoring; including recruitment statistics. The secondary aims will involve data collection and correlation analysis for targeted ultrasound parameters, biomarkers, disease activity scores and prediction of changes in treatment. The statistical methods will include: feasibility metrics, descriptive statistics, cross-tabulation and χ2 analysis, correlation analysis, regression analysis.Ethics and disseminationEthical approval is granted by NHS Research Ethics Committee. The sponsor is Cardiff and Vale University Health Board. We will publish the results in a peer-reviewed medical journal.Trial registration numberNCT05673278.
| S-EPMC10729071 | biostudies-literature
Project description:IntroductionA prospective evaluation of outcomes in a series of patients with post-prostatectomy incontinence (PPI) treated with two different devices is presented.MethodsConsecutive patients with PPI underwent interventions with an adjustable transobturator male system (ATOMS) or artificial urinary sphincter (AUS). Decisions were based on patient preference after physician counselling. Patient characteristics and operative and postoperative parameters including dryness, satisfaction, complications, revision and device durability were evaluated.ResultsOne hundred twenty-nine patients were included: 102 (79.1%) received ATOMS and 27 (20.9%) AUS. Mean follow-up was 34.9 ± 15.9 months. No difference was observed between patient age (p = 0.56), ASA score (p = 0.13), Charlson index (p = 0.57) and radiation (p = 0.3). BMI was higher for AUS (27.1 vs. 29.7; p = 0.003) and also baseline incontinence severity (7.9% mild, 44.1% moderate and 48% severe for ATOMS vs. 11.1% moderate and 88.9% severe for AUS; p = 0.0007). Differential pad test was higher for AUS (- 470 vs. - 1000 ml; p < 0.0001) and so was ICIQ-SF (15.62 vs. 18.3; p < 0.001), but total dryness (76.5 vs. 66.7%; p = 0.33), social continence (90.2 vs. 85.2%; p = 0.49) and satisfaction (92.2 vs. 88.9%; p = 0.69) were equivalent. The postoperative complication rate was similar (22.6 vs. 29.6%; p = 0.4). The surgical revision rate was higher for AUS (6.9 vs. 22.2%; p = 0.029) and also the explant rate but did not reach statistical significance (4.9 vs. 14.8%; p = 0.09). Time to explant was shorter for AUS (log-rank p = 0.021). Regression analysis revealed radiation (p = 0.003) and incontinence severity (p = 0.029) predict total dryness, while complications (p < 0.005) and type of device (p = 0.039) independently predict surgical revision.ConclusionsBoth ATOMS and AUS are effective devices. Pad test change for AUS exceeds that of ATOMS. The revision rate is higher for AUS, and durability is superior for ATOMS. The satisfaction rate is equivalent. Larger series and longer follow-up are needed to compare both devices more appropriately. According to our experience, the AUS is not the only gold standard for PPI.
| S-EPMC7854436 | biostudies-literature
Project description:Anal sphincter incontinence is a chronic disease, which dramatically impairs quality of life and induces high costs for the society. Surgery, considered as the best curative option, shows a disappointing success rate. Stem/progenitor cell therapy is pledging, for anal sphincter incontinence, a substitute to surgery with higher efficacy. However, the published literature is disparate. Our aim was to perform a review on the development of cell therapy for anal sphincter incontinence with critical analyses of its pitfalls. Animal models for anal sphincter incontinence were varied and tried to reproduce distinct clinical situations (acute injury or healed injury with or without surgical reconstruction) but were limited by anatomical considerations. Cell preparations used for treatment, originated, in order of frequency, from skeletal muscle, bone marrow or fat tissue. The characterization of these preparations was often incomplete and stemness not always addressed. Despite a lack of understanding of sphincter healing processes and the exact mechanism of action of cell preparations, this treatment was evaluated in 83 incontinent patients, reporting encouraging results. However, further development is necessary to establish the correct indications, to determine the most-suited cell type, to standardize the cell preparation method and to validate the route and number of cell delivery.
| S-EPMC8394955 | biostudies-literature
Project description:BACKGROUND:Patient reported outcomes regarding perianal disease and faecal incontinence in the community-based inflammatory bowel disease population are poorly described. AIMS:To determine the impacts of perianal disease and faecal incontinence on quality of life and employment in inflammatory bowel disease patients. METHODS:For this cross-sectional study, a comprehensive survey was sent out to members of the Dutch National Crohn's and Colitis patient organisation. Validated questionnaires regarding faecal incontinence and active perianal disease were used to estimate its prevalence's. The effect on the quality of life (36-Item Short Form Survey) and on employment status (multivariate binary regression analysis) was assessed in this inflammatory bowel disease population. RESULTS:A total number of 1092 returned questionnaires (58% responders) were used for analysis; 750 respondents (69%) were female; mean age was 47 years (IQR 35-59). In 621 patients (57%) Crohn's disease, in 422 (39%) ulcerative colitis and in 49 (4%) patients unclassifiable inflammatory bowel disease was self-reported. The 114 patients (10%) with a stoma were excluded for continence related analyses. Faecal incontinence was reported in 555 patients (57%), was comparable between the different inflammatory bowel disease diagnoses and affected all 36-Item Short Form Survey subscales adversely (incontinence vs continence: Physical functioning 75 vs 84, P < 0.0001; Limitations due to physical health 49 vs 63, P < 0.0001; Limitations due to emotional problems 49 vs 64, P < 0.0001; Energy/fatigue 47 vs 53, P < 0.0001; Emotional well-being 71 vs 74, P = 0.005; Social functioning 63 vs 73, P < 0.0001; Pain 66 vs 75, P < 0.0001; General health 41 vs 48, P < 0.0001). Active perianal disease was reported in 39% Crohn's disease, 16% ulcerative colitis (84% fissures) and 20% unclassifiable inflammatory bowel disease patients. Faecal incontinence was more common in patients with perianal disease (67% vs 53%, P = 0.003). When correcting for age, disease duration, inflammatory bowel disease-related surgery and faecal incontinence, active perianal disease was independently affecting employment (OR 0.67; 95% CI 0.50-0.91; P = 0.01). CONCLUSIONS:Faecal incontinence and perianal disease are quality of life determining factors. Faecal incontinence needs more attention among clinicians, and development of new (drug) therapies needs to be focussed on perianal disease.
| S-EPMC5947114 | biostudies-literature
Project description:Introduction and hypothesisTAS-303, which selectively inhibits noradrenaline reuptake, was developed for treating stress urinary incontinence (SUI). The proximal urethra mainly comprises smooth muscle fibers in which ?1 adrenergic receptors are abundant. This study was conducted to evaluate the effect of TAS-303 on urethral function and its safety profile in female patients with SUI.MethodsIn total, 16 women (age, 20-64 years) with SUI and?>?5.0 g of leakage in the 1-h pad test at screening were randomized and administered the assigned treatment in a double-blind manner. The primary end point was change in the maximal urethral closure pressure (MUCP) at 6 h post-dose. The secondary end point was change in the urethral closure pressure of the entire urethra and each urethral region (proximal, middle, and distal) at 6 h post-dose. The results were analyzed using a t-test.ResultsThe mean change ± standard deviation in MUCP at 6 h post-dose was 3.473?±?12.154 cmH2O for TAS-303 and 2.615?±?9.794 cmH2O for placebo (between-group difference: 0.858 cmH2O, P?=?0.8047). The mean changes ± standard deviation in urethral closure pressure of the proximal urethra at 6 h after the administration of TAS-303 18 mg and placebo were 3.863?±?10.941 and 1.634?±?12.093, respectively (between-group difference: 2.229 cmH2O, P?=?0.5976).ConclusionsNo significant difference in MUCP and urethral closure pressure was found between TAS-303 and placebo. However, the change in the proximal urethral closure pressure with TAS-303 was larger than that with placebo. This suggests that TAS-303 has pharmacological effects on urethral sphincteric function.
| S-EPMC7902327 | biostudies-literature