Constipation affects 4 million Americans, predominantly women and the elderly. Its pathophysiology is incompletely understood and its treatment is unsatisfactory. Laxative-dependent, and unable to accomplish natures' call, many resort to desperate treatments. About 50 percent of patients with constipation exhibit uncoordinated or dyssynergic defecation. Uncontrolled studies suggest that biofeedback therapy may improve symptoms in these patients. But, whether the improvement is due to the behavioral intervention or a consequence of excess attention is not known. Biofeedback therapy is labor-intensive, expensive and only available in a few centers. In order to treat the many patients in the community, a home-based, self-training program is essential. Our proposal addresses three objectives; 1) to determine the efficacy of biofeedback therapy by performing a randomized controlled study in patients with dyssynergic defecation. After diagnostic evaluation with colon transit study, anorectal manometry and stool diaries, 90 patients will be randomized to receive standard treatment consisting of diet, habit-training and laxatives or biofeedback therapy consisting of neuromuscular conditioning or sham feedback therapy. Short-term (3 month) and long-term (12 month) assessments of anorectal physiology-defecation index, anal relaxation, fecom expulsion time and colon transit time and symptomatology-bowel satisfaction score, straining effort, laxative consumption score and stool form and consistency will be performed. 2) To investigate the efficacy of home-training versus office-based biofeedback therapy and if it is cost-effective, 100 patients will be randomized to receive either home-training using a hand-held portable device and a silicon probe or biofeedback therapy for 3 months. Anorectal physiology and symptoms will be assessed and actuarial costs of each treatment will be compared. 3) For a condition that is entwined with psyche there is no information on quality of life or psychosocial function. We wish to investigate these parameters with validated instruments, SF-36 and SCL-90-R in 90 patients, before and after treatment and compare this with two controlled groups. This may provide impetus for new treatments such as psychotherapy. This first controlled study will determine the efficacy and scientific basis for a safe and alternative therapy for difficult defecation, provide new information that could facilitate home self-training and assess the impact of treatment on anorectal physiology, symptoms, quality of life and psychosocial aspects.
|Effective start/end date||10/1/99 → 6/30/14|