Trials / Terminated
TerminatedNCT00257842
Randomized Controlled Trial of Biofeedback Therapy for Dyssynergic Defecation
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Augusta University · Academic / Other
- Sex
- All
- Age
- 15 Years – 75 Years
- Healthy volunteers
- Not accepted
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 is due to behavioral modification or excessive attention is unknown. Methods: In a prospective randomized trial, the investigators 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Standard treatment, sham feedback and biofeedback therapy |
Timeline
- First posted
- 2005-11-23
- Last updated
- 2014-09-17
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00257842. Inclusion in this directory is not an endorsement.