ACTRN12620000067976
Completed
Phase 2
Botulinum toxin A injection into muscles of the pelvic floor as a treatment for chronic pelvic pain secondary to pelvic floor muscular spasm – A Pilot Study
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Mercy Hospital
- Enrollment
- 21
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Female patient aged 18\-45 years of age
- •Chronic pelvic pain of at least 12 months duration
- •Evidence of pelvic floor muscular spasm as assessed by the gynaecologist and pelvic floor physiotherapist – a pelvic floor pain map” will be used to aid in assessing muscle spasm and pain pre and post op and to guide injection areas.
- •Patient has had a laparoscopy and other causes of pelvic pain treated or excluded
- •Patient has had a course of conservative pelvic floor relaxation therapy with a qualified physiotherapist, patient is willing to continue this therapy post injection
- •Patient has been assessed clinically by the principal researcher or assistant researchers.
- •Patient has trialled a course of nerve modifying therapy eg amitriptyiline, gabapentin or pregabalin
Exclusion Criteria
- •Patient pregnant, lactating or planning pregnancy within 6 months of injection
- •Patient has a neurological or neuromuscular conditions eg Myaesthenia gravis, Eaton Lambert syndrome, Multiple sclerosis
- •Patient not willing to return for assessment over 3 visits in the 6 months following injection of Botox
Outcomes
Primary Outcomes
Not specified
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