None listed
Conditions
Brief summary
Persistent or chronic pelvic pain affects approximately 15% of women aged 18-50 with significant implications for patient quality of life. We plan to run a prospective observational study looking at the injection of botulinum toxin A (Botox) into the pelvic floor under ultrasound guidance and follow pain and quality of life scores in women who have failed conventional treatment. We hypothesise that injection of Botox into selected muscles of the pelvic floor will lead to improved pain scores and quality of life in women with chronic pelvic pain secondary to pelvic floor muscular spasm.
Interventions
Trial patients will undergo a general anaesthetic. Under ultrasound guidance and with the aid of a nerve stimulator, a solution of 100 Botox units (BotoxTM, Allergen) in 15ml of 0.75% ropivacaine drawn up into a 20ml syringe and will be injected be the accredited gynaecologist into the levator ani, obturator interns, and superficial perineal muscles if indicated (solution to be distributed across the muscle groups as indicated by clinical examination). A standardized pelvic floor pain map will b
Trial patients will undergo a general anaesthetic. Under ultrasound guidance and with the aid of a nerve stimulator, a solution of 100 Botox units (BotoxTM, Allergen) in 15ml of 0.75% ropivacaine drawn up into a 20ml syringe and will be injected be the accredited gynaecologist into the levator ani, obturator interns, and superficial perineal muscles if indicated (solution to be distributed across the muscle groups as indicated by clinical examination). A standardized pelvic floor pain map will be used preoperatively to guide injection. Following injection of Botox a pudendal block is performed per vagina with 5ml of 0.75% ropivacaine bilaterally to improve post-operative comfort. The amount of ropivacaine in the pudendal block will be reduced if the patient's weight is <62kg (recognising a total maximal dose of 3mg/kg ropivacaine). For example, for a 50kg woman, a 2.5mL 0.75% ropivacaine block will be inserted each side. Patients will be assessed at time points 0, 6weeks, 3months, 6months. Assessment will include an internal pelvic examination and completion of a standardised questionnaire.
Sponsors
Mercy Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
No
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
Outcome results
None listed