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

• Register: ISRCTN
• Last refreshed on: 13 January 2015
• Main ID: ISRCTN34573685
• Date of registration: 29/09/2006
• Prospective Registration: No
• Primary sponsor: Record Provided by the NHSTCT Register - 2006 Update - Department of Health
• Public title: 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
• Date of first enrolment: 16/09/2005
• Target sample size: 20
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN34573685
• Study type: Interventional
• Study design: Double blinded randomised controlled trial (Treatment)

Countries of recruitment

United Kingdom

Contacts

• Name: J Davies

Key inclusion & exclusion criteria

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.
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.

Age minimum:
Age maximum:
Gender: Not Specified

Health Condition(s) or Problem(s) studied

Nervous System Diseases: Pelvic floor dyssynergia
Nervous System Diseases
Pelvic floor dyssynergia

Intervention(s)

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.

Primary Outcome(s)

Improvement in quality of life.

Secondary Outcome(s)

Not provided at time of registration

Secondary ID(s)

N0050171996

2005-001378-29

Source(s) of Monetary Support

Bradford Teaching Hospitals NHS Foundation Trust, Bradford Royal Infirmary