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.
- Conditions
- Chronic pelvic pain and levator spasm.Alternative and Complementary Medicine - Pain management
- Registration Number
- ACTRN12605000559617
- Lead Sponsor
- Allergan Australia Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 60
(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).
(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
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method