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Trial registered on ANZCTR


Registration number
ACTRN12620000067976
Ethics application status
Approved
Date submitted
10/11/2019
Date registered
28/01/2020
Date last updated
28/01/2020
Date data sharing statement initially provided
28/01/2020
Date results information initially provided
28/01/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Botox injection into the pelvic floor muscles for the treatment of chronic pelvic pain.
Scientific title
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
Secondary ID [1] 299769 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic pelvic pain 315132 0
Condition category
Condition code
Reproductive Health and Childbirth 313452 313452 0 0
Other reproductive health and childbirth disorders
Musculoskeletal 313453 313453 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 316023 0
Treatment: Drugs
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321923 0
Change in pain (as assessment via Likert scale).
Timepoint [1] 321923 0
6 weeks, 3 months, 6 months post Botox injection.
Primary outcome [2] 322383 0
Change in quality of life (assessed by WHO QOL Bref) from baseline following Botox injection
Timepoint [2] 322383 0
6 weeks, 3 months, 6 months post Botox injection
Primary outcome [3] 322384 0
Change in pelvic muscle tenderness as assessed on standardised clinical examination
Timepoint [3] 322384 0
6 weeks, 3 months, and 6 months post Botox injection.
Secondary outcome [1] 376716 0
Change in opiate use compared to baseline following Botox injection. This will be assessed by patient report - all doses of opiates will be converted to equivalent morphine dose.
Timepoint [1] 376716 0
6 weeks, 3 months, 6 months post Botox injection

Eligibility
Key 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
Minimum age
18 Years
Maximum age
45 Years
Gender
Females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
As this is a pilot study a power calculation has not been performed. Baseline to 6 weeks and 12 weeks post treatment data will be compared for multiple, dependent non-parametric data. P-values will be two tailed and significance set at the 5% level.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 15131 0
Mercy Hospital for Women - Heidelberg
Recruitment postcode(s) [1] 28425 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 304235 0
Charities/Societies/Foundations
Name [1] 304235 0
Norman Beischer Medical Research Foundation
Address [1] 304235 0
Level 1, 459 Toorak Road,
Toorak, Victoria, 3142.
Telephone: (03) 9296 2003
Email: admin@nbmrf.org.au
Country [1] 304235 0
Australia
Primary sponsor type
Hospital
Name
Mercy Hospital
Address
163 Studley Road
Heidelberg VIC
3084
Country
Australia
Secondary sponsor category [1] 304474 0
None
Name [1] 304474 0
Address [1] 304474 0
Country [1] 304474 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304695 0
Mercy Hospital for Women HREC
Ethics committee address [1] 304695 0
Level 6
163 Studley Road
Heidelberg VIC 3084
Ethics committee country [1] 304695 0
Australia
Date submitted for ethics approval [1] 304695 0
03/12/2015
Approval date [1] 304695 0
06/02/2016
Ethics approval number [1] 304695 0

Summary
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.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes
None

Contacts
Principal investigator
Name 97898 0
Dr Lenore Ellett
Address 97898 0
Mercy Hospital for Women
163 Studley Road
Heidelberg VIC 3084
Country 97898 0
Australia
Phone 97898 0
+61 3 8458 4444
Fax 97898 0
Email 97898 0
lenore@crosbie.com.au
Contact person for public queries
Name 97899 0
Dr Samantha Mooney
Address 97899 0
Mercy Hospital for Women
163 Studley Road
Heidelberg VIC 3084
Country 97899 0
Australia
Phone 97899 0
+61 3 84584444
Fax 97899 0
Email 97899 0
endosurgeryfellow@mercy.com.au
Contact person for scientific queries
Name 97900 0
Dr Samantha Mooney
Address 97900 0
Mercy Hospital for Women
163 Studley Road
Heidelberg VIC 3084
Country 97900 0
Australia
Phone 97900 0
+61 3 84584444
Fax 97900 0
Email 97900 0
endosurgeryfellow@mercy.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
There is no role for data sharing with this project. Our ethics agreement allows for use of our data by the research team only.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary
We have not analysed our data yet. We plan to have this analysis by mid 2020.