Volitional control of the pelvic floor in incomplete spinal cord injury
| ISRCTN | ISRCTN53547889 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN53547889 |
| Protocol serial number | N0209178291 |
| Sponsor | Record Provided by the NHSTCT Register - 2006 Update - Department of Health |
| Funder | Royal National Orthopaedic Hospital NHS Trust (UK) NHS R&D Support Funding |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 08/08/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
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
Prof Michael Duncan Craggs
Scientific
Scientific
RNOHT
Royal National Orthopaedic Hospital
Brockley Hill
Stanmore
HA7 4LP
United Kingdom
| Phone | +44 (0)20 8909 5343 |
|---|---|
| michael.craggs@ucl.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Volitional control of the pelvic floor in incomplete spinal cord injury |
| Study objectives | This proposal is for a pilot study to determine the extent of residual voluntary control over the pelvic floor muscles and to investigate the training effects of these muscles on changes in strength of the pelvic sphincters and involuntary contractions of the urinary bladder in incomplete spinal cord injury. A positive outcome from this study will be used to establish funding for a broader based programme of research. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Urological and Genital Diseases |
| Intervention | Single randomised within-subject cross-over study in comparing the interventional effects of volitional pelvic floor muscle training (PFMT) with our standard dorsal penile nerve (DPN) electrical stimulation techniques (neuromodulation) on bladder and sphincter function in male patients with an incomplete spinal cord injury. Randomisation of intervention will help to ensure control of order effect. The principal measures will be the percentage inhibition on neurogenic detrusor overactivity, percentage changes in bladder capacity and percentage changes in sphincter strength and dyssynergia. |
| Intervention type | Other |
| Primary outcome measure(s) |
Extent of residual voluntary control over the pelvic floor muscles. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/04/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Key inclusion criteria | Subjects with in incomplete spinal cord injury. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/07/2005 |
| Date of final enrolment | 01/04/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
RNOHT
Stanmore
HA7 4LP
United Kingdom
HA7 4LP
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
08/08/21016: No publications found in PubMed, verifying study status with principal investigator.
