Open label longitudinal study of Botox and chronic pelvic pain 03/102
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.
Allergan Pty Ltd
58 participants
Apr 19, 2005
Interventional
Conditions
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.
Eligibility
Inclusion Criteria1
- (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
Exclusion Criteria1
- (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.
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Interventions
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.
Locations(1)
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ACTRN12605000515695