Status:
TERMINATED
Randomized Controlled Trial of Biofeedback Therapy for Dyssynergic Defecation
Lead Sponsor:
Augusta University
Conditions:
Dyssynergia
Eligibility:
All Genders
15-75 years
Phase:
NA
Brief Summary
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 i...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00257842
Last Update
September 17 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Iowa
Iowa City, Iowa, United States, 52242