CompletedPhase 4ACTRN12605000559617

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.


Sponsor

Allergan Australia Pty Ltd

Enrollment

60 participants

Start Date

Jan 7, 2004

Study Type

Interventional

Conditions

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.


Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 55 Yearss

Plain Language Summary

Simplified for easier understanding

This is a clinical study looking at: 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.. It may be open to women aged 18 to 55. Key requirements include: (1)History of chronic pelvic pain for two or more years (2)Documented pelvic floor hypertonicity, with at least two of the following: Muscular myal... Participation typically involves medical assessments and follow-up visits as part of the research.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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

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


Locations(1)

Australia

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ACTRN12605000559617