Contact information
Type
Scientific
Primary contact
Mr R Mathew
ORCID ID
Contact details
Academic Surgical Unit
Castle Hill
Cottingham
East Yorkshire
HU16 5JQ
United Kingdom
+44 (0)1482 875 875
r.mathew@hull.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0084122586
Study information
Scientific title
A phase III, multicentre, single blind, randomised controlled trial in the use of hyperbaric oxygen therapy versus biofeedback therapy in patients with chronic faecal incontinence associated with pudendal neuropathy
Acronym
Study hypothesis
To determine and compare the effects of hyperbaric oxygen therapy versus biofeedback on incontinence severity, Quality of Life, anorectal neurophysiology and daily episodes.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Signs and Symptoms: Faecal incontinence
Intervention
A) hyperbaric oxygen therapy versus B) biofeedback.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
22/01/2003
Overall trial end date
01/06/2005
Reason abandoned
Eligibility
Participant inclusion criteria
100 patients, 50 on each arm.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
50 patients in each arm
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
22/01/2003
Recruitment end date
01/06/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Academic Surgical Unit
Cottingham, East Yorkshire
HU16 5JQ
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Research organisation
Funder name
The North and South Bank Research and Development Consortium
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary