| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN53547889 |
| Date ISRCTN assigned | 29/09/2006 |
| Local reference number(s) | N0209178291 |
| Public title | Volitional control of the pelvic floor in incomplete spinal cord injury |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Urological and Genital Diseases: |
| Study hypothesis | 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. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | No ethics information provided as of 29 September 2006 |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Subjects with in incomplete spinal cord injury. |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/07/2005 |
| Anticipated end date | 01/04/2006 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | 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. |
| Primary outcome measure(s) | Extent of residual voluntary control over the pelvic floor muscles. |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Royal National Orthopaedic Hospital NHS Trust
NHS R&D Support Funding |
| Sponsor name | Record Provided by the NHSTCT Register - 2006 Update - Department of Health |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Prof Michael Duncan Craggs |
| Contact details | RNOHT
Royal National Orthopaedic Hospital
Brockley Hill
Stanmore
United Kingdom
HA7 4LP |
| Contact telephone | +44 x 5343 |
| Contact fax | +44 020 8909 5343 |
| Contact email | michael.craggs@ucl.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN53547889 |
| Date last extracted from ISRCTN register | 17/04/2008 |
