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Trial registered on ANZCTR


Registration number
ACTRN12605000559617
Ethics application status
Approved
Date submitted
14/09/2005
Date registered
29/09/2005
Date last updated
29/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
A double blind randomised, placebo-controlled trial evaluating the effect of Botox injected into the pelvic floor of women with chronic pelvic pain and levator spasm.
Scientific title
To establish the role of botulinum toxin (Botox) injected in the pelvic floor muscles of women with objectively demonstrable pelvic floor spasm, and a history of chronic pelvic pain, as regards to improvement in pain, quality of life and sexual function, compared with placebo.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic pelvic pain and levator spasm. 684 0
Condition category
Condition code
Alternative and Complementary Medicine 759 759 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Botox injected into the pelvic floor. Twelve weeks intensive follow-up with further follow up at six months following BOTOX injection.
Intervention code [1] 602 0
Treatment: Drugs
Comparator / control treatment
Control group
Placebo

Outcomes
Primary outcome [1] 954 0
To assess the effect of Botox injected into the pelvic floor of women compared to placebo using VAS pain assessment
Timepoint [1] 954 0
Primary outcome [2] 955 0
To assess the effect of Botox injected into the pelvic floor of women compared to placebo using Bladder and bowel symptoms
Timepoint [2] 955 0
Primary outcome [3] 956 0
To assess the effect of Botox injected into the pelvic floor of women compared to placebo using Quality of Life assessments
Timepoint [3] 956 0
Primary outcome [4] 957 0
To assess the effect of Botox injected into the pelvic floor of women compared to placebo using Sexual Activity
Timepoint [4] 957 0
Primary outcome [5] 958 0
To assess the effect of Botox injected into the pelvic floor of women compared to placebo using Diary assessments of medication use
Timepoint [5] 958 0
Primary outcome [6] 959 0
To assess the effect of Botox injected into the pelvic floor of women compared to placebo using Diary assessments of adverse events
Timepoint [6] 959 0
Primary outcome [7] 960 0
To assess the effect of Botox injected into the pelvic floor of women compared to placebo using Physical assessments with Digital vaginal assessment (modified Oxford scale muscle strength measurements)
Timepoint [7] 960 0
Primary outcome [8] 961 0
To assess the effect of Botox injected into the pelvic floor of women compared to placebo using Physical assessments with manometry and sEMG of the pelvic floor (resting tone pressure, maximum contraction pressure and relaxation pressure)
Timepoint [8] 961 0
Primary outcome [9] 962 0
Economic evaluation of treatments
Timepoint [9] 962 0
Secondary outcome [1] 1824 0
Timepoint [1] 1824 0

Eligibility
Key inclusion criteria
(1)History of chronic pelvic pain for two or more years (2)Documented pelvic floor hypertonicity, with at least two of the following: Muscular myalgia on palpationA pelvic floor resting manometry reading of >40cm waterDysmenorrhea and or dyspareunia that significantly alters quality of lifeWilling to attend the Clinic and comply with the Study requirements for the duration of the Study period i.e., 12 weeks & final follow up at approximately 6 months Age 18 and 55Botox naive (i.e. has not had previous injection of Botox in the pelvic floor).
Minimum age
18 Years
Maximum age
55 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
(1)Current pregnancy (documented by pregnancy test) or a desire for pregnancy during the study period(2)Inability to tolerate vaginal pelvic floor muscle examination and manometry.(3)Significant medical & or psycho-social problems(4)Breast feeding (5)Not willing to use a reliable method of contraception (e.g. barrier methods, the oral contraceptive pill, Depo Provera or other similar depot progestogen or intra- uterine contraceptive device)(6)Poor comprehension of written and spoken English (7)Contraindications for the use of Botox injections. ie: Known hypersensitivity to the formulation of Botox or Xylocaine. (8) Patient currently using aminoglycoside antibiotics(9)History of any neuro-muscular & or bleeding disorder.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Solutions are prepared by a third party not involved in the study and delivered to the examination room without either the patient or the staff attending the study patient aware of the content.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised blocks of ten
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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)

Funding & Sponsors
Funding source category [1] 840 0
Commercial sector/Industry
Name [1] 840 0
Allergan Australia Pty Ltd
Address [1] 840 0
Country [1] 840 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Allergan Australia Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 707 0
None
Name [1] 707 0
not applicable
Address [1] 707 0
Country [1] 707 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2108 0
South Eastern Area and Illawarra Health Service, Eastern Division
Ethics committee address [1] 2108 0
Ethics committee country [1] 2108 0
Australia
Date submitted for ethics approval [1] 2108 0
Approval date [1] 2108 0
Ethics approval number [1] 2108 0

Summary
Brief summary
To examine the effects of Botox injected into the pelvic floor muscles of women with demonstrable pelvic floor spasm, as regards to pain symptoms, sexual activity, quality of life and economic analysis compared to placebo.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35446 0
Address 35446 0
Country 35446 0
Phone 35446 0
Fax 35446 0
Email 35446 0
Contact person for public queries
Name 9791 0
Ms Sherin Jarvis
Address 9791 0
Department of Endogynaecology
Royal Hospital for Women
Level 2
Barker Street
Randwick NSW 2031
Country 9791 0
Australia
Phone 9791 0
+61 2 93826557
Fax 9791 0
+61 2 93826244
Email 9791 0
jarviss@sesahs.nsw.gov.au
Contact person for scientific queries
Name 719 0
Ms Sherin Jarvis
Address 719 0
Department of Endogynaecology
Royal Hospital for Women
Level 2
Barker Street
Randwick NSW 2031
Country 719 0
Australia
Phone 719 0
+61 2 93826557
Fax 719 0
+61 2 93826244
Email 719 0
jarviss@sesahs.nsw.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary