Treatment Of Severe Fecal Incontinence Research Articles

Design of Novel Artificial Anal Sphincter

ObjectivesArtificial anal sphincter is considered to be a good method for the treatment of severe fecal incontinence, but there are problems of low biomechanical compatibility in clinical application. The purpose of this study is to design a novel artificial anal sphincter that can output stable loading force to solve the mechanical mismatch between artificial anal sphincter and intestinal tissue caused by excessive or too small local pressure on the intestine. Material and methodsAiming at the shortcomings of the existing artificial anal sphincter, a novel artificial anal sphincter with constant force mechanism is designed based on the C-shaped SMA sheet of Ti-55.9at%Ni and combined with the normal defecation mechanism of human body. In this paper, the chord length l of C-shaped SMA sheet is used as the design variable, and the artificial anal sphincter is optimized and verified initially by using finite element analysis method. ResultsThe results show that the artificial anal sphincter can achieve a constant force to clamp the intestine in a large displacement range when the chord length l of the C-shaped SMA is 13 mm, the chord height h is 1.5 mm, the width w is 2 mm, and the thickness δ is 0.2 mm. ConclusionThe design of artificial anal sphincter with constant force loading mechanism has a good effect in solving the biomechanical compatibility problem between the implant device and the intestinal tissue. In addition, the designed artificial anal sphincter occupies a small space, which provides a new idea for future clinical application.

Long-term cost-effectiveness analysis of sacral neuromodulation in the treatment of severe faecal incontinence.

The aim of this study was to evaluate the long-term cost-effectiveness of sacral neuromodulation in the treatment of severe faecal incontinence as compared with symptomatic management. In the public health field, a micro-costing evaluation method was conducted from the perspectives of the health system and the society. The incremental cost-effectiveness ratio was used as a decision index, and we considered various scenarios to evaluate the impact of the cost of symptomatic management and percutaneous nerve evaluation success rate in its calculation. Clinical data were retrieved from a consecutive cohort of 93 patients with severe faecal incontinence undergoing sacral neuromodulation after a failure of conservative (pharmacological and biofeedback) and/or surgical (sphincteroplasty) first-line treatments were considered. The long-term incremental cost-effectiveness ratio comparing sacral neuromodulation versus symptomatic management was 14347€/QALY and 28523€/QALY from the societal and health service provider's perspectives, respectively. If the definitive pulse generator implant success rate was 100%, incremental cost-effectiveness would correspond to 6831€/QALY and 16761€/QALY, respectively. Sacral neuromodulation may be considered a cost-effective technique in the long-term treatment of severe faecal incontinence from the societal and health care sector perspectives. Improving patient selection and determining the predictive outcome factors for successful sacral neuromodulation in the treatment of faecal incontinence would improve cost-effectiveness.

Economic burden of long-term treatment of severe fecal incontinence

IntroductionFind out the long-term economic cost associated with the treatment of severe fecal incontinence by SNS versus symptomatic conservative treatment and definitive colostomy. MethodsDetailed descriptive study of the costs of the healthcare process (interventions, consultations, devices, complementary tests, hospitalization, etc.) of 3 treatment alternatives for fecal incontinence using analytical accounting tools of the Health Service based on clinical activity data. The frequency of use of health resources or the quantity of products dispensed in pharmacies (medication, diapers, ostomy material, etc.) was estimated in each case. Costs derived from adverse situations were included. Patients with severe fecal incontinence, defined by a score greater than 9 on the Wexner severity scale, in whom first-line treatments had failed, were included.Data from a consecutive cohort of 93 patients who underwent an SNS between 2002 and 2016 were used; patients who underwent definitive colostomy (n=2); parastomal hernia (n=3); and colostomy stenosis (n=1). ResultsThe mean cumulative cost in 10 years per patient in each alternative was: € 10,972.9 symptomatic treatment (62% diapers); € 17,351.57 SNS (95.83% interventions; 81.6% devices); € 25,858.54 definitive colostomy (70.4% ostomy material and accessories). ConclusionsManagement of severe fecal incontinence implies a great burden in economic terms. The colostomy is the alternative that generates the most direct cost, followed by SNS and symptomatic treatment.

Impacto económico del tratamiento a largo plazo de la incontinencia fecal grave

IntroductionFind out the long-term economic cost associated with the treatment of severe fecal incontinence by SNS versus symptomatic conservative treatment and definitive colostomy. MethodsDetailed descriptive study of the costs of the healthcare process (interventions, consultations, devices, complementary tests, hospitalization, etc.) of 3 treatment alternatives for fecal incontinence using analytical accounting tools of the Health Service based on clinical activity data. The frequency of use of health resources or the quantity of products dispensed in pharmacies (medication, diapers, ostomy material, etc.) was estimated in each case. Costs derived from adverse situations were included. Patients with severe fecal incontinence, defined by a score greater than 9 on the Wexner severity scale, in whom first-line treatments had failed, were included.Data from a consecutive cohort of 93 patients who underwent an SNS between 2002 and 2016 were used; patients who underwent definitive colostomy (n=2); parastomal hernia (n=3), and colostomy stenosis (n=1). ResultsThe mean cumulative cost in 10 years per patient in each alternative was: € 10,972.9 symptomatic treatment (62% diapers); € 17,351.57 SNS (95.83% interventions; 81.6% devices); € 25,858.54 definitive colostomy (70.4% ostomy material and accessories). ConclusionsManagement of severe fecal incontinence implies a great burden in economic terms. The colostomy is the alternative that generates the most direct cost, followed by SNS and symptomatic treatment.

Sacral nerve stimulation for the treatment of severe fecal incontinence: long-term quality of life and functional outcomes

The aim is to determine whether good functional and quality of life results of sacral nerve stimulation (SNS) in patients with severe fecal incontinence are maintained in the long-term. Consecutive cohort of patients with severe fecal incontinence not responding to conservative (drugs and/or biofeedback) or surgical (sphincteroplasty) treatment, undergoing SNS between 2002 and 2013. Patients with a definitive implant were individually assessed in consultation throughout the follow-up, until January 2016. Defeca-tory function was assessed by Wexner score and stool diary, and perceived quality of life by FIQL and EQ-5D question-naires. Acute percutaneous nerve evaluation (PNE) was performed on 93 patients; a temporary electrode was implanted in 91 (79.1% women, mean age 62.5 years), obtaining a good functional response in 64. A permanent implant was per-formed in 61 patients, with a mean follow-up of 78.1 months (SD: 35.4; range 1-161); at the end of the study 42 patients remained in follow-up. A significant decrease was observed in the number of days per week with an incontinent episode, from 4.98 (SD 2.1) to 1.25 (SD 1.7), and in Wexner score from 16.88 (SD 2.74) to 6.95 (SD 3.54). Specific FIQL and generic EQ-5D questionnaires showed a significant improvement in quality of life. Long-term functional and quality of life outcomes of SNS for the treatment of severe faecal incontinence is maintained, with individual follow-ups that reach 10 years.

Functional Results and Quality of Life Following Magnetic Anal Sphincter Augmentation in Severely Incontinent Patients.

Magnetic anal sphincter augmentation is a novel surgical option in the treatment of severe fecal incontinence. This study aimed to analyze functional results, quality of life, and satisfaction after implantation in the mid-term, and to identify factors associated with success of this new treatment. All patients, who underwent magnetic anal sphincter augmentation procedure at a single center between December 2008 and January 2016, were consecutively included. Symptom severity [Cleveland Clinic Incontinence Score (CCIS)], quality of life [Fecal-Incontinence Quality of Life Questionnaire (FIQL)], bowel diary data, and patients' satisfaction were assessed before and after implantation. Forty-five patients (43 female), mean (s.d.) age 66.82 (±10.07), were followed for a median of 36 months (range 6-84). Two patients were explanted and 1 lost to follow-up. On a 3-week diary, major leakage rate significantly improved as did CCIS and FIQL. No significant difference was seen for flatus and minor leaks. Postoperative decrease of CCIS by ≥5.5 points correlated best with satisfaction, expressed by 22 patients (48% in intention-to-treat analysis). An independent predictive factor for success after implantation was no previous fecal incontinence surgical treatment. Satisfaction, functional, and quality of life outcomes improve significantly following magnetic anal sphincter augmentation.

Design and assessment of novel artificial anal sphincter with adaptive transcutaneous energy transfer system

This paper presents the in vitro assessment of a novel elastic scaling artificial anal sphincter system (ES-AASS) with an adaptive transcutaneous energy transfer system (TETS) for treatment of severe faecal incontinence (FI). The proposed adaptive TETS has a phase control, which can maintain the output voltage at ∼ 7 V across the full range of the coupling coefficient variation (from 0.09–0.31) during the whole process of charging with a phase shift of 177.5° to 79.1°. A maximum surface temperature of 42.2 °C was measured above the secondary coil during an energy transmission of 3.5 W in air. The specific absorption rate (SAR) and current density analysis of the biological three-layers structure, including the skin, fat and muscle) surrounding the coil pair were analysed and the results of simulation analysis showed that the value of SAR and current density were very small at any given transmission condition compared with the basic restrictions of the International Commission on Non-Ionizing Radiation Protection (ICNIRP). In conclusion, in vitro experimental results showed that the ES-AASS can control simulated faecal behaviour effectively and the performance of TETS was validated.

Magnetic anal sphincter augmentation in patients with severe fecal incontinence.

Fecal incontinence is a common, distressing condition with limited surgical options. This study examines the results of magnetic sphincter augmentation in patients with severe fecal incontinence. This was a single-center, prospective, nonrandomized investigation. This study was conducted in a private colorectal practice. The cohort included all of the patients implanted with magnetic sphincter augmentation between January 2012 and October 2013. Magnetic sphincter augmentation was studied. Adverse events, symptom severity, quality of life, bowel diary, and manometry data were collected. Eighteen patients (15 women), with mean age of 69 years (range, 31-91 years), were implanted with magnetic sphincter augmentation. Follow-up ranged from 353 to 738 days. Previous treatment consisted of peripheral nerve evaluation test in 10 patients (56%), 2 patients (11%) with previous permanent sacral nerve stimulation, and 1 patient (6%) with previous implantation of an artificial bowel sphincter. Implantation was successful in 17 (94%) of 18 patients. Five patients (29%) had postoperative pain, and 5 patients (29%) had temporary swelling and erythema in both gluteal regions after the implantation. No devices were explanted during the follow-up. Cleveland Clinic Incontinence Score decreased from a mean of 17.5 (range, 14.0-20.0) to 7.3 (range, 0-12.0), and Fecal Incontinence Quality of Life scores improved in all of the domains. Bowel diary results showed that 76% of the patients with implants experienced a ≥50% reduction in the number of fecal incontinence episodes per week. Manometry at 6 months after implantation showed increased mean resting and squeeze pressures. This study does not allow for comparison between surgical treatments and involves a limited number of patients. Magnetic sphincter augmentation shows consistent results for the treatment of severe fecal incontinence in this patient group. The surgical procedure is straightforward as compared with other implantable devices. The safety profile is acceptable. Magnetic sphincter augmentation is a promising new treatment with the potential to become a first-line surgical therapy for patients with severe fecal incontinence.

Sacral Nerve Stimulation for the Treatment of Severe Faecal Incontinence: Results After 10 Years Experience

IntroductionThe objective of this study was to report our experience with sacral nerve stimulation for the treatment of severe faecal incontinence after the first 10 years with this technique. Materials and methodsBetween 2001 and 2011, 49 patients with severe faecal incontinence underwent sacral nerve stimulation. Anorectal manometry, endoanal ultrasound and pudendal nerve latency were performed. Bowel habit diary, severity of faecal incontinence and quality of life scales were evaluated preoperatively and at the end of follow-up. ResultsMorbidity occurred in a third of patients, mostly minor. Four definitive devices were explanted. With a median follow-up of 37 months, severity of faecal incontinence, urge and incontinence episodes significantly improved at the end of follow-up. Patients’ subgroup with a major follow-up of 5 years significantly improved the severity of faecal incontinence but not the parameters of the bowel habit diary. Quality of life showed no significant improvement. Descriptive data of patients with sphincter defects did not show worse results than that of patients with sphincter integrity. ConclusionSacral nerve stimulation is a safe technique for severe faecal incontinence with good functional medium-term results. In the long term, severity of the faecal incontinence also improves, but studies with larger sample are necessary to show if other clinical parameters and the quality of life support this information. Preliminary results in patients with sphincter defects suggest that this technique could be effective in this group, but future studies will have to confirm these findings.

Neuromodulación sacra en el tratamiento de la incontinencia fecal grave: resultados tras 10 años de experiencia

IntroductionThe objective of this study is to report our experience with sacral nerve stimulation for the treatment of severe faecal incontinence after the first 10 years with this technique. Material and methodsBetween 2001 and 2011, 49 patients with severe faecal incontinence underwent sacral nerve stimulation. Anorectal manometry, endoanal ultrasound and pudendal nerve latency were performed. Bowel habit diary, severity of faecal incontinence and quality of life scales were evaluated preoperatively and at the end of follow-up. ResultsMorbidity occurred in a third of patients, mostly minor. Four definitive devices were explanted. With a median follow-up of 37 months, severity of faecal incontinence, urge and incontinence episodes significantly improved at the end of follow-up. Patients’ subgroup with major follow-up of 5 years significantly improved the severity of faecal incontinence but not the parameters of the bowel habit diary. Quality of life showed no significant improvement. Descriptive data in patients with sphincter defects did not show worse results than with sphincter integrity. ConclusionSacral nerve stimulation is a safe technique for severe faecal incontinence with good functional medium-term results. In the long term, severity of the faecal incontinence also improves but studies with larger sample are necessary to show if other clinical parameters and the quality of life support this information. Preliminary results in patients with sphincter defects suggest that this technique could be effective in this group but future studies will have to confirm these findings.

Sacral nerve stimulation in the treatment of severe faecal incontinence: long-term clinical, manometric and quality of life results

Faecal incontinence (FI) is a complex and multifactorial health problem. Treatment has to be individualised, analysing the aetiology and gravity in every case. Sacral nerve stimulation (SNS) has been shown to effectively improve treatment of FI. Fifty patients with severe FI treated with SNS between March 2002 and December 2010 were analysed. Preoperative assessment included physical examination, anorectal manometry and anal endosonography. Anal continence was evaluated using the Wexner continence grading system. Quality of life was evaluated using the Fecal Incontinence Quality of life Scale (FIQLS). Follow-up appointments were scheduled at 1, 6 and 12months and annually thereafter. Wexner score, FIQLS and the ability to defer defecation were assessed at each visit. Fifty patients underwent a permanent implant. The overall mean follow-up period was 55.52±31.84months. After 6months, SNS significantly improved FI and positively impacted quality of life, as evidence by significant improvements in all 4 scales of the FIQLS. Anorectal manometry showed a trend towards an increase in maximum resting pressure and maximum pressure. After the first assessment at 6months, Wexner score and FIQLS remained stable. Ability to defer defecation was also maintained. During follow-up, 3 patients (6%) experienced implant site pain and episodes of extremity pain and paresthesias that were refractory to medical management and required device explantation. The implant site infection rate was 2%. Analysis of our long-term results confirms the safety and effectiveness of SNS in the management of patients with FI.

Technical and Functional Results of the Artificial Bowel Sphincter for Treatment of Severe Fecal Incontinence

Fecal incontinence is a socially devastating problem that can be cured by the artificial bowel sphincter in selected cases. This study evaluates short- and long-term morbidity and functional results of the artificial bowel sphincter. This study is a retrospective evaluation of consecutive patients. This study was conducted at 2 academic colorectal units. Between May 2003 and July 2010, all consecutive patients who underwent artificial bowel sphincter implantation for severe fecal incontinence were included in the study. The artificial bowel sphincter was implanted through 2 incisions made in the perineum and suprapubic area. Patients were reviewed at months 1, 6, and 12, and then annually. Mortality, morbidity (early infection within the first 30 days after implant, and late thereafter), and reoperations including explantations were analyzed. Anal continence was evaluated by means of the Cleveland Clinic Florida score. Mean follow-up was 38 months (range, 12-98). Between May 2003 and July 2010, 21 consecutive patients with a mean age of 51 years (range, 23-71) underwent surgery. There was no mortality. All patients presented with at least 1 complication. Infection or cutaneous ulceration occurred in 76% of patients, perineal pain in 29%, and rectal evacuation disorders in 38%. The artificial bowel sphincter was definitely explanted from 17 patients (81%). The artificial sphincter was able to be activated in 17 patients (81%), and continence was satisfactory at 1 year in those who still had their sphincter in place (n = 12). There is a very high rate of morbidity and explantation after implantation of an artificial bowel sphincter for fecal incontinence. Four of 21 patients who still had an artificial sphincter in place had satisfactory continence at a mean follow-up of 38 months.

Long‐term results of artificial bowel sphincter for the treatment of severe faecal incontinence. Are they what we hoped for?

This study evaluates the long-term morbidity, functional results and quality of life (QOL) after treatment of severe faecal incontinence (FI) with the Acticon Neosphincter (American Medical Systems, Minneapolis, Minnesota, USA). Between 1996 and 2002, 17 consecutive patients (14 female, 3 male; median age 46) underwent sphincter implantation. Clinical evaluation, incontinence severity and QOL were assessed. Anorectal manometry, endoanal ultrasound and pudendal nerve latency were performed preoperatively and at several stages of follow-up. The study was completed in December 2007. Mean follow-up was 68 months (range: 3-133). Morbidity occurred in 100% of patients from which 65% required at least one re-operation. After the first implant, 11 devices had to be removed (65%). Seven patients had a new implant. At the final stage, Acticon was activated in 9 cases (53%). Severity of FI improved from a median of 17.5 preoperatively to 9 (P = 0.005), 5.5 (P = 0.005) and 10 (P = 0.092) at 6, 12 months and at the end of follow-up, respectively. There was a significant improvement in QOL in all postoperative controls (P < 0.05). Severity of FI did not show a correlation with QOL in the preoperative period, but did at 6, 12 months and at the end of follow-up. Mean maximum resting pressure significantly increased with the full anal cuff. There is a high rate of morbidity, surgical re-interventions and explants after Acticon implant. Patients should be clearly informed about this before surgery. However, patients who have not had Acticon Neosphincter explanted, experience a significant improvement in anal continence and QOL.

Value of sacral nerve stimulation in the treatment of severe faecal incontinence: a comparison to the artificial bowel sphincter

Sacral nerve stimulation (SNS) is a recent treatment option in the management of severe faecal incontinence (FI) that offers promising results. The aim of this study was to compare SNS to artificial bowel sphincter (ABS) implanted patients to assess the rationale of this approach in achieving satisfying functional results and improved quality of life (QoL). Among 27 patients tested (December 2001 and April 2004), 15 patients were successfully managed with SNS. They were compared to 15 matched patients implanted with ABS in a previous period (control group). Assessment of continence level (Cleveland Clinic score), constipation score (Knowles, Eccersley, Scott Score) and QoL (Short-Form 36) were prospectively collected. Both groups were comparable for clinical parameters (age, gender, anal testing and aetiology of incontinence) and anal physiology. The mean postoperative continence score was significantly higher in the SNS group [9.4 (+/-3.3) vs 5.7 (+/-3.9), P < 0.01]; however, the mean constipation score was higher in the ABS group (6.3 +/- 6.3 vs 12.8 +/- 5.7, P < 0.01). The mean QoL score was similar in both groups. The mean follow-up after implantation was 15 (+/-9) months in the SNS group, and 43 (+/-33) months in the ABS group. In this study, SNS offers satisfying results in terms of QoL, similar to that of ABS. Although it seems to be less effective in restoring continence level, symptoms of outlet obstruction are more frequent after ABS. This SNS approach should be proposed as a first-line treatment of FI in selected patients. ABS should remain an option that can improve function.

The ProTect device in the treatment of severe fecal incontinence: preliminary results of a multicenter trial

Patients suffering from severe fecal incontinence (FI) in whom surgical treatment has either failed or is inappropriate due to high operative risks and those who refuse to undergo surgery are condemned to living with their embarrassing symptoms, often responsible for progressive social isolation. ProTect is a new, relatively simple, medical device intended for selected patients suffering from severe FI. It consists of a pliable, silicone catheter with an inflatable balloon that seals the rectum at the anorectal junction, acting like an anal plug. The proximal part of the catheter incorporates two contacts that monitor the rectum for the presence of feces. The patient is alerted to an imminent bowel movement and, hence, a potential fecal accident, through a beeper. A multicenter trial has been set up to assess the reliability of the device in preventing episodes of FI and to evaluate its impact on quality of life. Patients with significant FI (CCF>10) were prospectively entered into this 14-day study. Two quality of life questionnaires and a daily log of bowel activity and incontinent episodes were completed before and during the study. Currently, the study enrolled 17 patients and 11 patients (9 women, 2 men) with a mean age of 66 years (range, 46-85) completed the trial. In these 11 subjects, there was an overall significant improvement in the quality of life (p<0.05) and a significant reduction in incontinence scores (p<0.001) while using ProTect compared to baseline. The ProTect is a safe non-surgical device that is able to prevent episodes of FI. It is unique because it can be used according to a patient's needs without interfering with activities of daily living.

Systematic review of safety and effectiveness of an artificial bowel sphincter for faecal incontinence.

The aim was to determine the safety and effectiveness of the implantation of an artificial bowel sphincter for the treatment of severe faecal incontinence. Medical bibliographic databases, the internet and reference lists were searched from January 1966 to January 2003. Only the lowest level of evidence was available for inclusion in this systematic review. Case series and case reports were selected to assess safety, whereas only case series were selected to assess effectiveness. Fourteen studies met the inclusion criteria. A number of safety issues were reported, including high explantation rates, and rates of adverse events owing to infection, device malfunction, ulceration and pain. Results in published reports were not analysed on an intention-to-treat basis. Continence, quality of life and manometry scores were reported for patients with a functioning device at the end of follow-up. These patients experienced a significant improvement in their level of continence. As no outcome data were presented for those with a non-functioning or explanted device, it is possible that such patients may have a worsened degree of incontinence or decreased quality of life. Implantation of an artificial bowel sphincter is of uncertain benefit and may possibly harm many patients. Patient selection is therefore critical and should be enhanced by higher-quality research.

The procon incontinence device: a new nonsurgical approach to preventing episodes of fecal incontinence.

Treatment of severe fecal incontinence (FI) is essentially surgical. However, patients in whom surgery has failed, those who have high operative risks, and those who refuse to undergo surgery are often condemned to living with this embarrassing condition. The Procon incontinence device, a relatively simple, nonsurgical device, may represent a good solution in preventing episodes of FI, thus improving quality of life in these individuals. This device consists of a disposable, pliable rubber catheter with an infrared photo-interrupter sensor and flatus vent holes on the distal tip that is connected to a pager (or "beeper"). The catheter is inserted in the rectum and held in place by a 20-cc capacity cuff, which acts as a temporary mechanical barrier to stool leakage. Stool entering the rectum is sensed by the photo-interrupter sensor, which then alerts the patient to an imminent bowel movement. Voluntary evacuation is accomplished by deflating the balloon and removing the catheter. The aim of this study was to evaluate the efficacy, reliability, and safety of the Procon device in a group of patients with FI. Patients with significant FI who had undergone anorectal manometry, ultrasound, and electromyography with pudendal nerve terminal motor latency assessment were prospectively entered into this study. The Procon device was used for 14 consecutive days. A quality of life diary and daily log of bowel activity and incontinent episodes were completed before and after the end of the study. Seven patients (five female and two male) with a mean age of 72.7 yr (range 39-81 yr) were evaluated. Etiology of incontinence included idiopathic in four patients, sphincter defect in two, and neurological disorder in one patient. There was an overall significant improvement in the quality of life (p < 0.05) and a significant reduction in incontinence scores with the Procon device (p < 0.05). The Procon is a unique, safe, and promising device that is able to prevent episodes of FI without the need for surgery, thereby improving quality of life. Its role includes use in patients with severe FI who are unfit to undergo surgery, those in whom previous surgical treatments have failed, or those who do not wish to undergo surgery.

The Procon incontinence device: a new nonsurgical approach to preventing episodes of fecal incontinence

OBJECTIVES: Treatment of severe fecal incontinence (FI) is essentially surgical. However, patients in whom surgery has failed, those who have high operative risks, and those who refuse to undergo surgery are often condemned to living with this embarrassing condition. The Procon incontinence device, a relatively simple, nonsurgical device, may represent a good solution in preventing episodes of FI, thus improving quality of life in these individuals. This device consists of a disposable, pliable rubber catheter with an infrared photo-interrupter sensor and flatus vent holes on the distal tip that is connected to a pager (or “beeper”). The catheter is inserted in the rectum and held in place by a 20-cc capacity cuff, which acts as a temporary mechanical barrier to stool leakage. Stool entering the rectum is sensed by the photo-interrupter sensor, which then alerts the patient to an imminent bowel movement. Voluntary evacuation is accomplished by deflating the balloon and removing the catheter. The aim of this study was to evaluate the efficacy, reliability, and safety of the Procon device in a group of patients with FI. METHODS: Patients with significant FI who had undergone anorectal manometry, ultrasound, and electromyography with pudendal nerve terminal motor latency assessment were prospectively entered into this study. The Procon device was used for 14 consecutive days. A quality of life diary and daily log of bowel activity and incontinent episodes were completed before and after the end of the study. RESULTS: Seven patients (five female and two male) with a mean age of 72.7 yr (range 39–81 yr) were evaluated. Etiology of incontinence included idiopathic in four patients, sphincter defect in two, and neurological disorder in one patient. There was an overall significant improvement in the quality of life ( p < 0.05) and a significant reduction in incontinence scores with the Procon device ( p < 0.05). CONCLUSION: The Procon is a unique, safe, and promising device that is able to prevent episodes of FI without the need for surgery, thereby improving quality of life. Its role includes use in patients with severe FI who are unfit to undergo surgery, those in whom previous surgical treatments have failed, or those who do not wish to undergo surgery.