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.

Allergan Australia Pty Ltd0 sites60 target enrollmentSeptember 29, 2005

Overview

No summary available.

Registry

who.int

Start Date

September 29, 2005

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

Female

Sponsor

Allergan Australia Pty Ltd

•(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.