View clinical trials related to Fecal Incontinence.
Filter by:The aim of this randomized controlled clinical trial, prospective study is to developing a new incontinece care product for containing the fecal incontinence and to examine the effect of this new product on prevention of perineal dermatitis.
Fecal incontinence (FI), defined as the involuntary passage of stool for more than 3 months and is a devastating disease. The negative impact on quality of life has been consistently demonstrated. The prevalence of FI is probably underestimated in most studies. Currently conservative treatment is only modestly effective and surgical treatment is complex and expensive with less than optimal efficacy. The investigators developed an "anal tape" using a commercially available elastic band with a special adhesive that is approved for use in the skin. A special design of the tape can be applied to the skin surrounding the anus providing support and additional pressure forces to the anal sphincter. This is a 4 week, prospective, non blinded, cross-over study to explore the efficacy and safety of this device in patients with FI. The primary endpoint will be improvement in quality of life.
Background: Fecal incontinence (FI) affects 2-13% of an adult general population. The prevalence increases with age, and after 50 years of age prevalence rates up to 26% in women have been reported. Quality of life in patients with FI is decreased considerably, in a similar extent as in patients with ulcerative colitis in relapse. Management of FI usually involves a stepwise approach; beginning with more conservative strategies and moving on to more appropriately tailored medications, bowel-retraining, biofeedback and psychosocial support. Although a combination of these treatment alternatives often improves symptoms they are not always successfully. Neuromodulation is a relatively new treatment modality for FI that is based on recruitment of residual anorectal neuromuscular function pertinent to continence by electrical stimulation of the peripheral nerve supply. Sacral Nerve Stimulation (SNS) is one type of neuromodulation and it employs direct electrical stimulation of the sacral nerves. Recently an alternative neuromodulation technique to SNS has been developed in treating FI i.e. tibial nerve stimulation. The tibial nerve contains afferent and efferent fibers originating from the forth and the fifth lumbar nerves and the first, second and third sacral nerves. Thus, stimulation of the tibial nerve may lead to changes in anorectal neuromuscular function similar to those observed with SNS but without the need of a permanent surgically implanted device. Tibial nerve stimulation is therefore an attractive treatment alternative for FI patients since the treatment is well-tolerated and treatment results have been very promising. Aim: The overall aim is to measure the effect of percutaneous tibial nerve stimulation (PTNS) in combination with biofeedback on symptoms in consecutive FI patients compared with biofeedback alone. The investigators also aim to study which FI patients have most profit of the addition of PTNS. Methods: The study will take place at the Pelvic Floor Unit, department of Gastroenterology, University Hospital Linköping. Prior to the first visit to the hospital a symptom diary will be mailed to the FI patients and they are instructed to record their FI symptoms, bowel habits and gastrointestinal symptoms prospectively on a 24-hour diary during 2 weeks. Before consideration of enrolment into the study, gastroenterologists assess all the patients' medical history and perform a physical examination. Subjects will also have an endoanal ultrasonography and the investigators will measure rectal volumes, sensational thresholds and anal sphincter function. FI patients who fulfil inclusion criteria will then be randomly assigned to either PTNS in combination with biofeedback or biofeedback alone. The treatment will be performed by physiotherapists.
This research aims to investigate the feasibility for the treatment of OnPulse(TM) for the treatment of faecal incontinence (FI) (including mixed faecal and urinary incontinence) in older people living at home or in a Care Home. It will determine patient acceptability, tolerability and usability of the T-2 gekoTM device for FI by assessing: 1. device user factors: acceptability of use, ease of device placement, ease of device interface control and understanding of device instructions; 2. tolerability of device: skin tolerability.
The ForConti Fecal Incontinence Management System (FIMS) is indicated for the management of accidental bowel leakage due to bowel incontinence. The ForConti FIMS is designed for self-insertion to seal and help prevent the involuntary leakage of stool, liquids and gases from the rectum. The purpose of the study is to demonstrate that the ForConti FIMS is safe and that it improves management of fecal incontinence and improves quality of life. Patients will record bowel events in a daily diary over a 6 week period, which includes 2 weeks without using the device followed by 4 weeks using the device. Quality of Life questionnaire will be completed before and after use of the device. Stool leakage data collected when the device is not being used will be compared with data collected during use of the device to determine effectiveness.
The aim of this study is to determine the success rate, the success duration, the complication rate, maintenance effort and quality of life several years after sacral nerve modulation (SNM) treatment for constipation or stool incontinence.
Background: Fecal incontinence (FI) is a common complaint, and is often associated with diarrhea and urgency. Foods that are high in fermentable oligo-, di-, and mono-saccharides and polyols (FODMAPs) cause symptoms of diarrhea and urgency. Thus, assessing the impact of a low FODMAP diet in FI patients is needed. Aims: 1. Compare the treatment response with a low FODMAP vs. psyllium based on number of episodes in patients with FI. 2. Compare the efficacy of a low FODMAP diet vs. psyllium in patients with FI on pre-specified clinical and quality of life endpoints. Methods: This is a prospective, randomized control trial of adults meeting the Rome III criteria for FI and at least 1 episode of FI due to loose stool per week. After a 2 week screening period and randomization, during which the severity of symptoms will be assessed and eligibility determined, patients will be randomized to psyllium vs. low FODMAP diet for 4 weeks. A total of 20 patients will be recruited for each arm. The primary endpoint will be treatment response based on number of incontinence episodes. A treatment response is defined as a reduction in the number of FI episodes/week.
Pressures measured by manometric solid-state catheters may differ according to the type of the catheter and specific anatomy and physiology of anorectum. The aim of the study is to establish the difference in recordings between 2 types of anorectal catheters used in pediatric patients and to validate the most appropriate way to diagnose of functional disorders.
Previous studies show that incontinence is relatively common during pregnancy and after delivery. Experiencing incontinence during pregnancy or in the first year after delivery increases the risk of long term incontinence. There is scarce documentation of the long term prevalence of anal incontinence (AI) in Norway. This study aims to explore prevalence and risk factors for incontinence approximately six years after delivery among the 1718 who participated in two previous studies exploring the prevalence and predictors of anal incontinence in late pregnancy and during the first year after first delivery, and the effect of pelvic floor muscle exercises as treatment for anal incontinence after delivery. Increased awareness and knowledge about risk factors and long term prevalence of anal incontinence among health professionals as well as pregnant and parous women may give indications about which women to target for preventative measures to reduce the risk of new onset of postpartum AI during pregnancy and after delivery. Further, increased knowledge may aid in planning individualized follow-up during pregnancy and the first year as well as in the long term among women with existing AI symptoms.
Anal Acoustic Reflectometry (AAR) is a technique that has been studied in our department over the last 6 years. Sound waves pass into a balloon placed in the anal canal and are used to measure the cross-sectional area. By gradually increasing and decreasing the pressure in the balloon the investigators can measure the pressure at which the cross-sectional area starts to increase and decrease, and the anal canal starts to open and close. This assessment mimics the natural opening and closing of the anal canal and the effect of squeezing the muscles. The gold standard investigation of the anal sphincter muscles has been manometry which measures anal canal pressure at rest and during squeeze. However, it has limitations. Despite the two measurements being within the normal range, some patients can have significant faecal incontinence. This has prompted clinicians to search for a better investigation to guide the management of this condition. AAR is a reproducible and repeatable technique that has been used as a research technique in the assessment of faecal incontinence. It has been shown to correlate with symptom severity and, unlike manometry, is able to distinguish between different symptomatic subgroups with faceal incontinence. In our studies so far the investigators have increased the bag inflation pressure a step at a time which means that each study takes about 20 minutes to perform. The limitation of this method is that during the measurement of squeeze pressure the sphincter muscle is subject to fatigue. A recent study using the acoustic technique in the urethra has demonstrated a faster method of recording measurements over an 8 minute period. The investigators propose to study the fatiguability effects of this faster technique and validate the method against the existing step-wise technique and standard anal manometry. Patients will be randomised into two groups: 1. Stepwise then fast-fill 2. Fast-fill then stepwise