A double blinded randomised controlled trial of injection of botulinum toxin versus normal saline into the puborectalis muscle in patients with pelvic floor dyssynergia.
Phase 1
- Conditions
- Obstructed defeacation
- Registration Number
- EUCTR2005-001378-29-GB
- Lead Sponsor
- Bradford Teaching Hospitals NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
Presence of obstructed defeacation according to the Rome II criteria
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Unfit for general anaesthesia, hypersensitivity to Botox, Myaesthenia gravis, Eaton Lamberrt Syndrome
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Relieve paradoxical puborectalis contraction in obstructed defeacation;Secondary Objective: Improve quality of life and constipation scores;Primary end point(s): Improved defeacation
- Secondary Outcome Measures
Name Time Method