Botox injection into the pelvic floor muscles for the treatment of chronic pelvic pain.

Phase 2

Completed

• Conditions: chronic pelvic pain; Reproductive Health and Childbirth - Other reproductive health and childbirth disorders; Musculoskeletal - Other muscular and skeletal disorders

• Registration Number: ACTRN12620000067976
• Lead Sponsor: Mercy Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-28
• Study Completion: 2020-02-03
• Last Update Posted: 2021-11-15

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 21

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified