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.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project (R01)
Project #
5R01DK057100-02
Application #
6402597
Study Section
General Medicine A Subcommittee 2 (GMA)
Program Officer
Hamilton, Frank A
Project Start
2000-09-01
Project End
2005-06-30
Budget Start
2001-07-01
Budget End
2002-06-30
Support Year
2
Fiscal Year
2001
Total Cost
$252,840
Indirect Cost
Name
University of Iowa
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
041294109
City
Iowa City
State
IA
Country
United States
Zip Code
52242
Rao, Satish S C; Valestin, Jessica A; Xiang, Xuelian et al. (2018) Home-based versus office-based biofeedback therapy for constipation with dyssynergic defecation: a randomised controlled trial. Lancet Gastroenterol Hepatol 3:768-777
Erdogan, A; Rao, S S C; Thiruvaiyaru, D et al. (2016) Randomised clinical trial: mixed soluble/insoluble fibre vs. psyllium for chronic constipation. Aliment Pharmacol Ther 44:35-44
Rao, S S C; Benninga, M A; Bharucha, A E et al. (2015) ANMS-ESNM position paper and consensus guidelines on biofeedback therapy for anorectal disorders. Neurogastroenterol Motil 27:594-609
Coss-Adame, Enrique; Rao, Satish S C; Valestin, Jessica et al. (2015) Accuracy and Reproducibility of High-definition Anorectal Manometry and Pressure Topography Analyses in Healthy Subjects. Clin Gastroenterol Hepatol 13:1143-50.e1
Coss-Adame, Enrique; Erdogan, Askin; Rao, Satish S C (2014) Treatment of esophageal (noncardiac) chest pain: an expert review. Clin Gastroenterol Hepatol 12:1224-45
Coss-Adame, Enrique; Rao, Satish S C (2014) Brain and gut interactions in irritable bowel syndrome: new paradigms and new understandings. Curr Gastroenterol Rep 16:379
Rao, Satish S C; Coss-Adame, Enrique; Tantiphlachiva, Kasaya et al. (2014) Translumbar and transsacral magnetic neurostimulation for the assessment of neuropathy in fecal incontinence. Dis Colon Rectum 57:645-52
Yu, Siegfried W B; Rao, Satish S C (2014) Anorectal physiology and pathophysiology in the elderly. Clin Geriatr Med 30:95-106
Fedewa, Amy; Rao, Satish S C (2014) Dietary fructose intolerance, fructan intolerance and FODMAPs. Curr Gastroenterol Rep 16:370
Bharucha, Adil E; Rao, Satish S C (2014) An update on anorectal disorders for gastroenterologists. Gastroenterology 146:37-45.e2

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