Condition category
Urological and Genital Diseases
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
08/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Michael Duncan Craggs

ORCID ID

Contact details

RNOHT
Royal National Orthopaedic Hospital
Brockley Hill
Stanmore
HA7 4LP
United Kingdom
+44 (0)20 8909 5343
michael.craggs@ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0209178291

Study information

Scientific title

Volitional control of the pelvic floor in incomplete spinal cord injury

Acronym

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.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

Extent of residual voluntary control over the pelvic floor muscles.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/07/2005

Overall trial end date

01/04/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Subjects with in incomplete spinal cord injury.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/07/2005

Recruitment end date

01/04/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

RNOHT
Stanmore
HA7 4LP
United Kingdom

Sponsor information

Organisation

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

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

08/08/21016: No publications found in PubMed, verifying study status with principal investigator.