Botulinum Toxin Type A for Pelvic Floor Dysfunction

N/A

Waitlist Available

Led By Eman A Elkadry, MD

Research Sponsored by Boston Urogynecology Associates

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks following pelvic floor injection

Awards & highlights

All Individual Drugs Already Approved

Summary

The purpose of this study is to determine whether there is a change in patient-reported pelvic pain following pelvic floor injections of 200 units of Botox compared with 20cc of normal saline.

Eligible Conditions

Pelvic Floor Dysfunction

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks following pelvic floor injection

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks following pelvic floor injection

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks following pelvic floor injection for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To evaluate the change in patient-reported pelvic pain following pelvic floor injections of 200 units of Botox compared with 20cc of normal saline.

Secondary study objectives

To evaluate the change in patient-reported pelvic pain following Botox injections in conjunction with pelvic floor physical therapy compared to saline injections with physical therapy.

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Botulinum Toxin Type AActive Control1 Intervention

Patients in the treatment group will receive 200 Units of Botulinum toxin diluted in 20 mL of saline injected globally into their pelvic floor muscles followed by 8 treatments of pelvic floor physical therapy.

Group II: SalinePlacebo Group1 Intervention

Patients in the placebo group will receive 20 mL of saline injected globally into their pelvic floor muscles followed by 8 treatments of pelvic floor physical therapy.

Do I qualify?Apply below to find out