Multicenter Randomized Controlled Trial to Compare the Outcome of Conservative Triple Target Treatment With EMG-Biofeedback in Chronic Obstipation
Multicenter Randomized Controlled Trial to Compare the Outcome of Conservative Triple Target Treatment With EMG-Biofeedback in Chronic Obstipation
Previous studies revealed only a low evidence for the various biofeedback methods and pelvic
 floor exercises for treatment of chronic obstipation. The number of randomized controlled
 trials is low with in part significant systemic deficiencies. However, the results from the
 previous study with 3T treatment in patients with obstructed defecation syndrome (ODS) are so
 promising that a further randomized controlled trial appears useful to demonstrate a higher
 degree of evidence. The purpose of this study is to determine whether triple target treatment
 (3T) or EMG-Biofeedback alone are effective in the treatment of chronic obstipation and if
 the duration of treatment (3, 6 or 9 months) influence the efficacy.
Methods in this parallel-group randomized multicenter study with blinded observer we enroll
 140 patients with chronic obstipation. The study is divided into two trials. After three
 months the first trial is completed and can be extended directly into the second trial
 (completed after 12 months) after an interim analysis. Primary endpoints are changes from
 baseline to three and twelve months in the Altomare ODS Score.
Inclusion Criteria:

 -  All Patients with chronic obstipation (Rom criteria II)

 Exclusion Criteria:

 -  Chronic inflammatory bowel disease, systemic peripheral neuropathy (MS, diabetes),
 disorders of enteric nervous system (Hirschsprung disease, chagas, IND, myopathy
 desmosis coli), idiopathic megacolon/megarectum, patients with mental or intellectual
 deficits.