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Fecal Incontinence clinical trials

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NCT ID: NCT03074461 Recruiting - Rectal Cancer Clinical Trials

Transverse Coloplasty vs. Side-to-end Anastomosis Following Low Anterior Resection (LAR): CSAR Trial

CSAR
Start date: April 5, 2017
Phase: N/A
Study type: Interventional

CSAR Trial's aim is to determine whether the transverse coloplasty pouch or the side-to-end anastomosis as rectal reservoir reconstruction offers the best functional results.

NCT ID: NCT03046810 Recruiting - Dermatitis Clinical Trials

Treatment of Incontinence Associated Dermatitis - Automated

TRIAD-A
Start date: April 1, 2017
Phase: N/A
Study type: Interventional

Incontinence and the skin irritation (dermatitis) associated with it are common problems. Treatment of dermatitis is effective, but requires effective cleaning and application of a barrier substance to prevent further contact between urine or feces and the skin. Water based cleansing with the addition of a pH balanced cleanser is more effective than standard abrasive cleansing with paper or a cloth, and is better tolerated by those with skin irritation. Zinc oxide based barriers effectively promote healing and prevent further skin damage. Spray forms are less cumbersome and generally preferred, but are difficult to for the patient to apply independently given the challenge of accessing the perineum. 40 patients, recruited from 3 specialty pelvic floor centers and 1 assisted living center will be provided a device that cleans, dries, and applies zinc oxide barrier spray with each use of the toilet. Dermatitis will be evaluated at the beginning of the study, and at weeks 1, 2 and 6 by medical staff using a standard scale (The Kennedy Scale).Quality of life will be measured using a visual analog scale derived from the quality of life in incontinence scale. The investigators hypothesize that the device will 1) effectively treat incontinence associated dermatitis, 2) prevent recurrence, and 3) be preferred over standard treatment.

NCT ID: NCT02888899 Recruiting - Fecal Incontinence Clinical Trials

Tibial Nerve Stimulation in Combination With Biofeedback

Start date: March 2016
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT02812823 Recruiting - Constipation Clinical Trials

Comparison of Anorectal Manometry and 3D Manometry in Diagnosis of Functional Disorders in Children

Start date: March 1, 2018
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT02414425 Recruiting - Fecal Incontinence Clinical Trials

Effect and Tolerance of Botulinum A Toxin Rectal Injections on Fecal Incontinence

FI_TOXIN
Start date: December 2015
Phase: Phase 3
Study type: Interventional

Fecal incontinence is a frequent pathology which concerns 10% of the general population and severely alters patients quality of life. The cost of urinary and faecal incontinence has been estimated to be $16 billions a year. Several treatments exist depending on the aetiology of the faecal incontinence: medical treatments, biofeedback and sacral nerve stimulation. Nevertheless, these treatments are not always effective (50-70% of success) and are not without side effects, particularly the sacral nerve stimulation (pain, infection, electrode displacement..). The intravesical injections of botulinum toxin have been used for several years for the treatment of urinary incontinence with overactive bladder. Several randomized trials have demonstrated the efficacy of these injections in patients with neurological disorders and overactive bladder, as well as in idiopathic overactive bladder. The toxin injections in the detrusor muscle increase the compliance and the bladder capacity and delay the initial appearance of detrusor uninhibited contraction. Furthermore, botulinum toxin decreases the urinary urgency. It maybe secondary to the reduction of the amplitude of the detrusor uninhibited contraction as well as to a direct effect of toxin on sensory pelvic nerve afferents. The botulinum toxin should play a role on motor afferents as well as on the sensory function of efferent nerves. The hypothesis is to demonstrate a decrease of active faecal incontinence and/or urgency episodes with improvement in quality of life, without any major side effects, in the patients included in this study. Nevertheless, the benefit of toxin injections are known to be temporary because of nerve re-growth. If we obtain similar results for fecal incontinence, it would be possible to schedule one to two injections a year because of the limited side-effects and invasiveness of the rectal injections.

NCT ID: NCT02196597 Recruiting - Quality of Life Clinical Trials

Value of Anorectal Manometry Before Ileo- or Sigmoidostomy Closure After Rectal Resection

Start date: January 2013
Phase: N/A
Study type: Observational

Background: High prevalence of fecal incontinence after rectal resection in patients with rectal carcinoma. Hypothesis: Anorectal manometry done before ileostomy or sigmoidostomy closure can predict fecal incontinence. Methods: Anorectal manometry before, 1 month and 6 month after closure. Anorectal endosonography before and 1 month after closure. Prediction of postoperative incontinence by the surgeon (digital sphincter examination). Visual analog scales for continence, subjective success of operation, and global well being; Wexner and Vaizey incontinence score; Parks incontinence classification; Rockwood fecal incontinence quality of life score; each before, 1 and 6 month after closure.

NCT ID: NCT02161003 Recruiting - Fecal Incontinence Clinical Trials

Stem Cells Therapy for Fecal Incontinence in Children After Posterior Sagittal Ano-rectoplasty

Start date: October 2013
Phase: Phase 1/Phase 2
Study type: Interventional

The problem of the incontinence imposes considerable strain on the child and their parents. These patients suffer from a long-life handicap and they need support and follow-up. The cost associated with these diseases has clearly been illustrated to be a major component in the healthcare spending picture, may be adding hundreds of thousands of dollars to healthcare cost, as well as loss of productivity in the work force. Fecal incontinence treatment has been a difficult challenge for surgeons for several generations until now the current traditional surgical result is unsatisfactory. Mesenchymal Stem Cells injection may represent a new attractive treatment option for anal sphincter lesions. Moreover, experimental injury of muscle of anal sphincter in rats has been successfully treated with stem cells injections. In this study, the investigators will shed more light on the ability of Mesenchymal Stem Cells to induce myogenesis and regenerate anal Sphincter of patients with fecal incontinence. It will be very useful to many Egyptian patients.

NCT ID: NCT02020915 Recruiting - Clinical trials for Focus: Anal Incontinence After Lateral Sphincterotomy for Chronic Anal Fissure

Ultrasound Guided Lateral Sphincterotomy: Long Term Results

Start date: October 2007
Phase: N/A
Study type: Observational

Ultrasound guided placement of the knife intersphincteric increases accuracy and safety during sphincterotomy. Secondly 3-D ultrasound visualizes that the internal anal sphincter is divided.

NCT ID: NCT01949922 Recruiting - Fecal Incontinence Clinical Trials

Treatment of Fecal Incontinence by Injection of Autologous Muscle Fibers Into the Anal Sphincter

Start date: April 2013
Phase: N/A
Study type: Interventional

Aim: To investigate efficacy and safety in a new treatment with injection of autologous muscle fibers into the anal sphincter in patients with fecal incontinence. Method: Patients with fecal incontinence after obstetric anal sphincter rupture will be included. After inclusion, they will be offered 3 months of pelvic floor muscle training. If the patients after completion of pelvic floor muscle training still suffer from fecal incontinence, the patients will be offered treatment with autologous muscle fiber injection into the anal sphincter. The patients will be followed one year after the injection. The autologous muscle fibers are harvested at the patients leg muscle, cut into small pieces and injected into the anal sphincter. A small part of the fibers are used for analysing number of muscle stem cells and thereby the regenerative potential of the sample. The study is a pilot study.

NCT ID: NCT00971269 Recruiting - Fecal Incontinence Clinical Trials

Pilot Study of NASHA/Dx Gel for Fecal Incontinence

Start date: January 2009
Phase: Phase 1/Phase 2
Study type: Interventional

The study is an open, prospective, single-site study where 16 patients suffering from fecal incontinence will be included. Change in fecal incontinence episodes after intersphincteric injection of NASHA/Dx gel 4x2 ml and retreatment 4x2 ml after 4 weeks will be measured.