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Neurotoxin
Ultrasound and EMG Guided Botox Injection for the Treatment of Non-Relaxing Puborectalis Syndrome
Phase 2 & 3
Waitlist Available
Led By Karen Noblett, MD
Research Sponsored by University of California, Irvine
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 baseline to 6 months
Awards & highlights
No Placebo-Only Group
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.
Eligible Conditions
- Anismus
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Symptoms Based on Scores Using the PAC-SYM and Wexner Constipation Questionnaires.
PAC-SYM and Wexner Scores
Secondary study objectives
Change in Pressures on Anal Manometry
Other study objectives
Change in quality of life based on scores using the PAC-QOL questionnaire.
Change in the anorectal angle during defecation using defecography
Side effects data
From 2021 Phase 3 trial • 300 Patients • NCT042495832%
Headache
1%
COVID-19
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment
Placebo
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Botulinum toxin (Botox) injectionExperimental Treatment1 Intervention
All patients will be given the active Botox injection and thus this study will remain open-label and non-randomized as this is a pilot study to determine initial efficacy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
botulinum toxin
2020
Completed Phase 3
~610
Find a Location
Who is running the clinical trial?
AllerganIndustry Sponsor
781 Previous Clinical Trials
276,678 Total Patients Enrolled
University of California, IrvineLead Sponsor
566 Previous Clinical Trials
1,933,071 Total Patients Enrolled
Karen NoblettLead Sponsor
American Urogynecologic SocietyOTHER
10 Previous Clinical Trials
683 Total Patients Enrolled
Karen Noblett, MDPrincipal InvestigatorUniversity of California, Irvine
10 Previous Clinical Trials
1,125 Total Patients Enrolled