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.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000515695

Enrollment

Registered

2005-09-26

Start date

2005-04-19

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

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.

Study design

Allocation

Non-randomised trial

Intervention model

Other

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Healthy volunteers

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

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.

Outcome results