Active clinical trials for "Fecal Incontinence"

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.

Faecal incontinence (FI) is the involuntary passage of gas, liquid or solid stool and is experienced by an estimated 1-10% of the population. The symptom is multifactorial and associated with many medical conditions and diseases. The symptom is investigated using structural and functional testing of the pelvic floor. Current investigation techniques have poor correlation between symptom severity and investigation results. These techniques are unable to provide prognostic outcomes, resulting in undirected referrals for treatment based on symptoms alone. This study aims to improve the assessment of FI through additional testing using Multiple Array Probe Leiden (MAPLe). This is a non-invasive medically certified device that detects the electromyography of the pelvic floor, how muscles respond to voluntary nervous stimulus, to identify areas of weakness. The aim of this study is firstly to identify which patient groups benefit from additional testing with MAPLe, and secondly to identify if directed treatment has been achieved. The study will take place across two NHS trusts, both with specialist pelvic floor services. Participants referred to each trust with FI who meet the inclusion/exclusion criteria will be recruited from designated pelvic floor clinics and referrals for anorectal physiology (ARP). Each participant will undergo routine anorectal physiological assessment with Anal Ultrasound (AUS) and High Resolution Anal Manometry (HRAM) and additional assessment with MAPLe. Participation is complete unless treatment has been advised, these participants will undergo repeat assessment with MAPLe at 6 months. Average participation will be 12 months. The results will be analysed to identify non-inferiority of MAPLe vs current techniques using Bland Altman method. Regression and correlation studies will be performed to identify which groups have benefited from assessment with MAPLe. An expert panel of specialists in the field of pelvic floor will be convened to determine the clinical utilisation of MAPLe.

Evaluation of Obstetrical Risk Factors for the development of Urinary and/or Fecal Incontinence according to a questionaire The questionaire will be filled by the study investigators after the women participating in the study sign their consent. The study is based solely on a questionaire and does not include any physical examination, blood exam or intervention. The study will be performed on the premises of Maaynei Hayeshua medical center. The inclusion criteria include women above the age of 18 who arrive to Maaynei Hayeshua Medical center for any reason. The data will be transferred to a computerized data base and analyzed statistically.