Condition category
Signs and Symptoms
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
27/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.doh.gov.uk

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

Publication citations

Additional files

Editorial Notes

27/09/2016: No publications found, verifying study status with principal investigator