Ultrasound and EMG Guided Botox Injection for the Treatment of Non-Relaxing Puborectalis Syndrome

• Status: Terminated
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

Our study aims to determine the efficacy of ultrasound and EMG guided Botox injections into the puborectalis muscle in women with non-relaxing puborectalis syndrome. With use of this technique, we believe we will find that Botox injections decrease symptom severity and improve quality of life (QOL) in patients with NRPS. All enrolled patients will receive ultrasound and EMG guided Botox injections at three points along the puborectalis muscle. Post-injection data will be obtained with a defecation diary and questionnaire data at the 2-week, 3-month, and 6-month intervals.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Karen Noblett; University of California, Irvine
• Collaborators: Allergan; American Urogynecologic Society
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

Inclusion Criteria:

• Female

• 18 years of age or older

• Diagnosis of non-relaxing puborectalis syndrome

Exclusion Criteria:

• Allergy or sensitivity to botulinum toxin

• Pregnancy or plan to become pregnant in the subsequent 6 months after injection

• Undiagnosed ano-rectal mass, lesion, or infection

• Stage II or greater rectocele