The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000515695
Ethics application status
Approved
Date submitted
14/09/2005
Date registered
26/09/2005
Date last updated
26/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Open label longitudinal study of Botox and chronic pelvic pain 03/102
Scientific title
To assess response to Botox injections of the pelvic floor in women with documented pelvic floor muscle spasm with regards to pain, quality of life and anxiety state and to determine an efficacy curve and dosage intervals for repeat injections.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic pelvic pain 640 0
Condition category
Condition code
Other 713 713 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Fifty-seven women who have completed the original RCT protocol are eligible to participate in this study. All women will receive 100 IU Botox diluted in 4.4 ml normal saline (25 IU units in 1.0 ml) and injected at four (4) sites in the pubococcygeus and puborectalis muscles bilaterally. They will be assessed at baseline, one month post injection, three months post injection and six months post injection.
Intervention code [1] 603 0
Treatment: Drugs
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 871 0
To assess response to Botox injections of the pelvic floor in women with documented pelvic floor muscle spasm with regards to pain
Timepoint [1] 871 0
At baseline, week four, week twelve and week twenty-six.
Primary outcome [2] 872 0
To assess response to Botox injections of the pelvic floor in women with documented pelvic floor muscle spasm with regards to quality of life
Timepoint [2] 872 0
At baseline, week four, week twelve and week twenty-six.
Primary outcome [3] 873 0
To assess response to Botox injections of the pelvic floor in women with documented pelvic floor muscle spasm with regards to anxiety state
Timepoint [3] 873 0
At baseline, week four, week twelve and week twenty-six.
Primary outcome [4] 874 0
Duration of efficacy
Timepoint [4] 874 0
Assessment at 6-monthly intervals after 26 weeks will be requested.
Secondary outcome [1] 1736 0
Timepoint [1] 1736 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 palpation(3) A pelvic floor resting manometry reading of >40cm water(4) Pelvic pain that significantly alters quality of life(5)Willing to attend the Department of Endo-Gynaecology and comply with the study requirements for the duration of the study period i.e., 26 weeks. Assessment at 6-monthly intervals after this time will be requested to determine duration of efficacy. (6)Age 18 to 55(7)Has completed the protocol for the RCT, study reference number 03/102
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 in the six months following injection (2)Inability to tolerate vaginal pelvic floor muscle examination, manometry and/or EMG.(3)Significant medical and 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. (8)Current use of aminoglycoside antibiotics(9)History of neuro-muscular and/or bleeding disorder.

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)
none
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
none
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

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)

Funding & Sponsors
Funding source category [1] 789 0
Commercial sector/Industry
Name [1] 789 0
Allergan Pty Ltd
Address [1] 789 0
Country [1] 789 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Allergan Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 653 0
None
Name [1] 653 0
not applicable
Address [1] 653 0
Country [1] 653 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2074 0
South eastern and Illawarra Area Health Service, Eastern Division
Ethics committee address [1] 2074 0
Ethics committee country [1] 2074 0
Australia
Date submitted for ethics approval [1] 2074 0
Approval date [1] 2074 0
Ethics approval number [1] 2074 0

Summary
Brief summary
: To assess response to Botox injections of the pelvic floor in women with documented pelvic floor muscle spasm with regards to pain, quality of life and anxiety state and to determine an efficacy curve and dosage intervals for repeat injections.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35849 0
Address 35849 0
Country 35849 0
Phone 35849 0
Fax 35849 0
Email 35849 0
Contact person for public queries
Name 9792 0
Ms Sherin Jarvis
Address 9792 0
Department of Endogynaecology
Royal Hospital for Women
Level 2
Barker Street
Randwick NSW 2031
Country 9792 0
Australia
Phone 9792 0
+61 2 93826557
Fax 9792 0
+61 2 93826244
Email 9792 0
Jarviss@sesahs.nsw.gov.au
Contact person for scientific queries
Name 720 0
Ms Sherin Jarvis
Address 720 0
Department of Endogynaecology
Royal Hospital for Women
Level 2
Barker Street
Randwick NSW 2031
Country 720 0
Australia
Phone 720 0
+61 2 93826557
Fax 720 0
+61 2 93826244
Email 720 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