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 |
| Protocol serial number | N0084122586 |
| Sponsor | Department of Health (UK) |
| Funder | The North and South Bank Research and Development Consortium |
- 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
Scientific
Academic Surgical Unit
Castle Hill
Cottingham, East Yorkshire
HU16 5JQ
United Kingdom
| Phone | +44 (0)1482 875 875 |
|---|---|
| r.mathew@hull.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Signs and Symptoms: Faecal incontinence |
| Intervention | A) hyperbaric oxygen therapy versus B) biofeedback. |
| Intervention type | Other |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/06/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 100 |
| Key inclusion criteria | 100 patients, 50 on each arm. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 22/01/2003 |
| Date of final enrolment | 01/06/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Academic Surgical Unit
Cottingham, East Yorkshire
HU16 5JQ
United Kingdom
HU16 5JQ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
27/09/2016: No publications found, verifying study status with principal investigator
