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
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