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ActivePhase 4ACTRN12605000515695

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.

Sponsor

Allergan Pty Ltd

Enrollment

58 participants

Start Date

Apr 19, 2005

Study Type

Interventional

Conditions

Chronic pelvic pain

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

Sex: FemalesMin Age: 18 YearssMax Age: 55 Yearss

Plain Language Summary

Simplified for easier understanding

This is a clinical study looking at: Open label longitudinal study of Botox and chronic pelvic pain 03/102. 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 my... 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

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) an

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)

Australia

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ACTRN12605000515695

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