BOD Trial: a double blinded randomised controlled trial of injection of botulinum toxin versus normal saline into the puborectalis muscle in patients with pelvic floor dyssynergia

ISRCTN ISRCTN34573685
DOI https://doi.org/10.1186/ISRCTN34573685
EudraCT/CTIS number 2005-001378-29
Secondary identifying numbers N0050171996
Submission date
29/09/2006
Registration date
29/09/2006
Last edited
30/01/2014
Recruitment status
Stopped
Overall study status
Stopped
Condition category
Nervous System 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

Mr J Davies
Scientific

Bradford Royal Infirmary
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom

Phone +44 (0)1274 452200
Email justin.davies@bradfordhospitals.nhs.uk

Study information

Study designDouble blinded randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesBotulinum 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedNervous System Diseases: Pelvic floor dyssynergia
InterventionThe 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)botulinum toxin
Primary outcome measureImprovement in quality of life.
Secondary outcome measuresNot provided at time of registration
Overall study start date16/09/2005
Completion date31/08/2007
Reason abandoned (if study stopped)Objectives no longer viable

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants20
Key inclusion criteriaPotential 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.
Key exclusion criteria1. 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.
Date of first enrolment16/09/2005
Date of final enrolment31/08/2007

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Bradford Royal Infirmary
Bradford
BD9 6RJ
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

Bradford Teaching Hospitals NHS Foundation Trust

No information available

Bradford Royal Infirmary

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan