Volitional control of the pelvic floor in incomplete spinal cord injury

ISRCTN	ISRCTN53547889
DOI	https://doi.org/10.1186/ISRCTN53547889
Secondary identifying numbers	N0209178291

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

RNOHT
Royal National Orthopaedic Hospital
Brockley Hill
Stanmore
HA7 4LP
United Kingdom

Phone	+44 (0)20 8909 5343
Email	michael.craggs@ucl.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
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	Extent of residual voluntary control over the pelvic floor muscles.
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/07/2005
Completion date	01/04/2006

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	Not provided at time of registration
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

England
United Kingdom

Study participating centre

RNOHT

Stanmore
HA7 4LP
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Royal National Orthopaedic Hospital NHS Trust (UK) NHS R&D Support Funding

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	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.