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

ISRCTN ISRCTN85575959
DOI https://doi.org/10.1186/ISRCTN85575959
Secondary identifying numbers N0084122586
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
27/09/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr R Mathew
Scientific

Academic Surgical Unit
Castle Hill
Cottingham, East Yorkshire
HU16 5JQ
United Kingdom

Phone +44 (0)1482 875 875
Email r.mathew@hull.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleA 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
Study objectivesTo determine and compare the effects of hyperbaric oxygen therapy versus biofeedback on incontinence severity, Quality of Life, anorectal neurophysiology and daily episodes.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSigns and Symptoms: Faecal incontinence
InterventionA) hyperbaric oxygen therapy versus B) biofeedback.
Intervention typeOther
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date22/01/2003
Completion date01/06/2005

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants50 patients in each arm
Key inclusion criteria100 patients, 50 on each arm.
Key exclusion criteriaNot provided at time of registration
Date of first enrolment22/01/2003
Date of final enrolment01/06/2005

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Academic Surgical Unit
Cottingham, East Yorkshire
HU16 5JQ
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.doh.gov.uk

Funders

Funder type

Research organisation

The North and South Bank Research and Development Consortium

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

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