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

Completed

Conditions: ervous System Diseases: Pelvic floor dyssynergia
Nervous System Diseases
Pelvic floor dyssynergia

Registration Number: ISRCTN34573685

Lead Sponsor: Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

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.