Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00257842
Status:
TERMINATED
Last Update Posted:
2014-09-17
First Post:
2005-11-21
Brief Title:
Randomized Controlled Trial of Biofeedback Therapy for Dyssynergic Defecation
Sponsor:
Augusta University
Organization:
Augusta University
Study Overview
Official Title:
None
Status:
TERMINATED
Status Verified Date:
2014-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None