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.

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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000559617

Enrollment

Registered

2005-09-29

Start date

2004-01-07

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 examine the effects of Botox injected into the pelvic floor muscles of women with demonstrable pelvic floor spasm, as regards to pain symptoms, sexual activity, quality of life and economic analysis compared to placebo.

Interventions

Botox injected into the pelvic floor. Twelve weeks intensive follow-up with further follow up at six months following BOTOX injection.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking 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 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).

Exclusion criteria

(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.

Outcome results