Condition category
Nervous System Diseases
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
30/01/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr J Davies

ORCID ID

Contact details

Bradford Royal Infirmary
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom
+44 (0)1274 452200
justin.davies@bradfordhospitals.nhs.uk

Additional identifiers

EudraCT number

2005-001378-29

ClinicalTrials.gov number

Protocol/serial number

N0050171996

Study information

Scientific title

Acronym

Study hypothesis

Botulinum Toxin injection into the pelvic floor muscles has been shown to be of benefit for patient whose muscles contract abnormally, causing difficulty in opening their bowels. However the studies that have shown this have all been small and have never been compared with a placebo. The difficulty in assessing the way patients respond to interventions when they have this condition may mean that the effect of the Botulinum injection is largely a placebo effect. The aim of this study is to assess the effect of the botulinum toxin injection compared with a placebo (saline). If it proves to be successful this will offer us a validated treatment in this difficult condition.

Ethics approval

Not provided at time of registration

Study design

Double blinded randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Nervous System Diseases: Pelvic floor dyssynergia

Intervention

The study aims to randomly assign ten patients to each treatment arm of the study. The patients will be selected from outpatient clinics after assessment has shown they have abnormal pelvic floor muscle contraction. They will complete a preoperative questionnaire containing a quality of life questionnaire, as well as specific questions on bowel function. After fully informed consent they will be randomised to receive either 30 unit Botulinum toxin A or an equivalent volume of normal saline injection into the puborectalis muscle under anaesthetic with ultrasound guidance to ensure accuracy of placement of the injection into the correct pelvic floor muscle.

Updated 30/01/2014: the trial was never completed and was stopped in 2007/2008.

Intervention type

Drug

Phase

Not Specified

Drug names

botulinum toxin

Primary outcome measures

Improvement in quality of life.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

16/09/2005

Overall trial end date

31/08/2007

Reason abandoned

Objectives no longer viable

Eligibility

Participant inclusion criteria

Potential participants in the study will be identified from the outpatient clinic after history examination and investigation suggest they have pelvic floor dyssynergia. They will be invited to take part in the trial after it has been explained to them. 20 participants will be recruited in to the study.

This standardised definition for pelvic floor dyssynergia was established at the multinational workshop for functional bowel disorders and is known as the Rome II criteria:
1. The patient must satisfy diagnostic criteria for functional constipation in diagnostic criteria C3.
2. There must be manometric, EMG, or Radiological evidence for inappropriate contraction or failure to relax the pelvic floor muscles during repeated attempts to defecate.
3. There must be evidence of adequate propulsive forces during attempts to defaecate.
4. There must be evidence of incomplete evacuation.
The key abnormality in this condition is the inappropriate contraction of the puborectalis muscle upon defecation.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

20

Participant exclusion criteria

1. If the patient's general health is poor such that anaesthesia present unacceptably high risks they will be precluded from the trial (as it is inappropriate to subject these patients through the risk of anaesthesia for unproven intervention).
2. Patients who are anticoagulated will also be excluded because of the risk of haematoma formation.

Recruitment start date

16/09/2005

Recruitment end date

31/08/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Bradford Royal Infirmary
Bradford
BD9 6RJ
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

Bradford Teaching Hospitals NHS Foundation Trust

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Bradford Royal Infirmary

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