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| Sponsored by: |
University of Iowa |
| Information provided by: | University of Iowa |
| ClinicalTrials.gov Identifier: | NCT00257842 |
Purpose
Constipation is a common disorder and current treatments are unsatisfactory. Biofeedback may help patients with constipation and dyssynergic defecation, but its efficacy is unproven and whether this is due to behavioral modification or excessive attention is unknown. Methods: In a prospective randomized trial, we investigated the efficacy of Biofeedback (manometric- assisted anal relaxation, muscle coordination and simulated defecation training), with either sham feedback therapy (Sham) or standard therapy (diet, exercise, laxatives; Standard) in 77 subjects (69 women) with dyssynergic defecation. Primary outcome measures included presence of dyssynergia, balloon expulsion time, number of complete spontaneous bowel movements (CSBM), and global bowel satisfaction. Data analyzed per protocol. Results: Subjects in the Biofeedback group were more likely to correct dyssynergia (p<0.0001), improve defecation index (p<0.0001) and decrease balloon expulsion time (p=0.001) and colonic marker retention (p=0.002) than other groups. The number of CSBM increased (p=0.001) and use of digital maneuvers decreased (p=0.03) only in Biofeedback group. Global satisfaction was higher (p=0.01) in the Biofeedback than Sham group. Conclusions: Biofeedback improves constipation and physiologic characteristics of bowel function in patients with dyssynergia. This effect is mediated by modifying physiologic behavior and colorectal function. Biofeedback is the preferred treatment for constipated patients with dyssynergia.
| Condition | Intervention |
|
Dyssynergia |
Procedure: Standard treatment, sham feedback and biofeedback therapy |
| MedlinePlus related topics: | Constipation |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment |
Eligibility
| Ages Eligible for Study: | 15 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:Patients were included if they fulfilled Rome II criteria for functional constipation, and during attempted defecation demonstrated a dyssynergic pattern of defecation, and either had prolonged difficulty with expelling a simulated stool (> 1 minute) or prolonged delay (> 20% marker retention) in colonic transit.
Exclusion Criteria: They were required to have no evidence of structural or metabolic diseases that could cause constipation, as assessed by colonoscopy/barium enema and routine hematological, biochemical and thyroid function tests. Patients taking drugs known to be constipating, for example opioids were either excluded or were asked to discontinue the drug prior to enrollment. Other exclusion criteria included: severe cardiac or renal disease, previous gastrointestinal, spinal or pelvic surgery except cholecystectomy, hysterectomy or appendectomy, neurologic diseases such as multiple sclerosis, stroke or spinal injury, impaired cognizance (mini-mental score < 15), legal blindness, pregnancy, rectal prolapse, anal fissure, and alternating constipation and diarrhea.
Contacts and Locations More Information
| Study ID Numbers: | RO1 DK 57100-05 |
| First Received: | November 21, 2005 |
| Last Updated: | November 21, 2005 |
| ClinicalTrials.gov Identifier: | NCT00257842 |
| Health Authority: | United States: Institutional Review Board |
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