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 |
| Clinical Trials Information System (CTIS) | 2005-001378-29 |
| Protocol serial number | N0050171996 |
| Sponsor | Record Provided by the NHSTCT Register - 2006 Update - Department of Health |
| Funders | Bradford Teaching Hospitals NHS Foundation Trust, Bradford Royal Infirmary |
- 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
Scientific
Bradford Royal Infirmary
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom
| Phone | +44 (0)1274 452200 |
|---|---|
| justin.davies@bradfordhospitals.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Double blinded randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | botulinum toxin |
| Primary outcome measure(s) |
Improvement in quality of life. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/08/2007 |
| Reason abandoned (if study stopped) | Objectives no longer viable |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 20 |
| Key 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. |
| Key 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. |
| Date of first enrolment | 16/09/2005 |
| Date of final enrolment | 31/08/2007 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Bradford Royal Infirmary
Bradford
BD9 6RJ
United Kingdom
BD9 6RJ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
