View clinical trials related to Constipation.
Filter by:Purpose: To assess whether EMG directed biofeedback therapy or Botulinum toxin type A injection of the levator ani muscles has any effect on pain from the levator ani syndrome, and, in addition, to what extent either treatment is superior to the other in terms of anorectal physiologic measurements, and quality of life. Study Design: Randomized, prospective, unblinded double-armed study with crossover. Methodology: Female subjects, aged 18 and over, with painful levator ani muscle spasm for at least one month duration will be randomized to receive either biofeedback therapy or Botulinum toxin type A injection. After randomization they will all undergo visual analog pain scoring, anorectal manometry, colonoscopy (if clinically indicated), and self-reported SF-36 quality of life measurement. Each patient will also complete numerical pain scale scoring, an SF-36, and a satisfaction questionnaire at each treatment visit and follow-up visit. Patients will submit these by mail. Identification numbers will be assigned to each subject for use on the SF-36 and Satisfaction Questionnaires throughout the study. Subjects will again undergo anorectal manometry at the end of their treatment arms. In the biofeedback arm patients will be treated biweekly for up to eight treatments and be provided exercises to practice at home based on their muscle function noted during the biofeedback training session. Subjects will keep a treatment diary of the exercises they do at home to help ensure compliance with the protocol. In the Botulinum toxin injection arm patients will be treated with scheduled injections of the levator ani muscles every six weeks for up to three total injections of 100U each. These injections will be directed to the painful areas of the levator muscles as guided by physical exam and EMG measurements. Should any patient fail their initial randomized treatment assignment (failure defined as "very dissatisfied" or "dissatisfied" on the satisfaction questionnaire), they will then be allowed to cross over to the other study arm. In addition to numerical pain scale scoring, an SF-36 questionnaire and anorectal manometry will also be repeated at the time of crossover. We intend to include all randomized patients in the final data analysis (according to their originally assigned treatment arm), regardless of outcome or reason for dropout, thus making this an "intent-to-treat" analysis. Pivotal Study Definitions: The definition of adequate pain reduction, for the purposes of data analysis, will be a reduction in a subject's mean pain score of two on a numerical pain scale (0-10). Failure of either therapy will be defined as a response of "very dissatisfied" or "dissatisfied" on the satisfaction questionnaire at the end of either biofeedback (eight treatment visits) or Botulinum toxin (three injections) both before and after crossover. Outcomes: We will determine the following for biofeedback therapy and Botulinum toxin type A injection: mean pain reduction, any differences in anorectal physiologic measurements (such as mean resting anal sphincter pressure), any changes in self-reported quality of life, and overall patient satisfaction.
Functional constipation is a common problem in Hong Kong. In a recent telephone survey, the prevalence of constipation as defined by Rome II criteria was 14%. Apart from organic, metabolic, neurological and drug induced causes, constipation most often arises from 2 disorders of colorectal motility: slow transit constipation or pelvic floor dysfunction or both. In the position statement from the American Gastroenterological Association , colon transit study was recommended to differentiate slow transit constipation from pelvic floor dysfunction. The management algorithm for normal transit and slow transit constipation was different and surgery should be considered for patients with slow transit constipation. In a recent paper by Bonapace , scintigraphy could be used to study both gastric, small bowel and large bowel transit time. The clinical diagnosis was changed in 51% of cases of constipation after scintigraphy and patient management such as adding a prokinetic agent, referral to biofeedback center, decision on surgery was affected in 64% of cases. Tegaserod is a recently approved prokinetic agent to be marketed in Hong Kong for the management of patients with constipation predominant irritable bowel syndrome (C-IBS). In a paper from Mayo clinic based on scintigraphic examination, tegaserod 2mg bd accelerates orocaecal transit in C-IBS patients. However studies in functional constipation basing on tegaserod 6 mg twice daily has not been published yet. Therefore, the Gastroenterology team and nuclear medicine teams of Princess Margaret Hospital, Gastroenterology teams of Caritas Medical Center and Yan Chai Hospital decide to study small and large bowel transit in functional constipation patients by scintigraphy. The efficacy of tegaserod in improving bowel transit is also examined in this randomized double blind placebo controlled study.
This study will evaluate the safety and effectiveness of the investigational drug DDP733 in treating female patients with IBS-c. A placebo control will be utilized.