Transcutaneous magnetic cortical stimulation (TMS) for assessment of the external anal sphincter in neurogenic faecal incontinence
| ISRCTN | ISRCTN03140344 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN03140344 |
| Protocol serial number | N0226118468 |
| Sponsor | Department of Health (UK) |
| Funder | South Manchester University Hospitals NHS Trust (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 29/07/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr ES Kiff
Scientific
Scientific
Department of General Surgery
South Manchester University Hospitals NHS Trust
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom
| Phone | +44 (0)161 291 6654 |
|---|---|
| Julie.Adger@smuht.nwest.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, single-blinded, controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 1. How do treatments for faecal incontinence have effect? 2. Does biofeedback have a neuroplastic cortical effect in patients with faecal incontinence? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Nervous System Diseases: Neurogenic faecal incontinence |
| Intervention | Patients randomised to 1 of 3 groups, all will receive current biofeedback therapy, but at different time intervals: 1. Group 1 - Behaviour Modification - Baseline TMS - Behaviour Modification - TMS - Biofeedback - TMS 2. Group 2 - Biofeedback - Baseline TMS - Biofeedback - TMS 3. Group 3 - (Control) - Baseline TMS - repeat TMS - Biofeedback - TMS |
| Intervention type | Other |
| Primary outcome measure(s) |
To establish any cortical neuroplastic changes or nerve conduction changes in response to current treatments for faecal incontinence. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/10/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 45 |
| Key inclusion criteria | 30 Patients over the age of 18 with neurogenic faecal incontinence will be recruited from the referrals to Mr ES Kiff and 15 controls. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/10/2002 |
| Date of final enrolment | 01/10/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of General Surgery
Manchester
M23 9LT
United Kingdom
M23 9LT
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2005 | Yes | No |
