Ultrasound and EMG Guided Botox Injection for the Treatment of Non-Relaxing Puborectalis Syndrome
Recruitment status was: Recruiting
Non-relaxing puborectalis syndrome (NRPS) is an obstructive defecatory disorder that presents with chronic constipation, anismus, or a sensation of incomplete rectal emptying. The specific etiology of this syndrome is unknown. The true incidence of NRPS is unknown, but it is estimated that 4% of patients with defecatory disorders have NRPS. Previous therapies for non-relaxing PRS have included biofeedback, pelvic floor physical therapy, dietary changes, laxatives, enemas, and surgical division of the puborectalis muscle. Unfortunately, responses to these treatments have been variable at best. Direct injection of botulinum toxin (Botox) into the puborectalis muscle is an alternative approach for treating NRPS and has recently been reported in a limited number of studies. Botox blocks cholinergic nerve endings in the autonomic nervous system and has been used to weaken the puborectalis muscle in constipated patients.
Our study aims to determine the efficacy of ultrasound and EMG guided Botox injections into the puborectalis muscle in women with NRPS. 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.
We plan to compare patient reported symptoms, symptom severity, and QOL prior to Botox injections with symptoms and QOL at 2-week, 3-month, and 6-month intervals after Botox injection into the puborectalis muscle 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. Additional injections will be offered to patients who fail the initial treatment.
|Non-relaxing Puborectalis Syndrome||Drug: botulinum toxin||Phase 2 Phase 3|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Ultrasound and EMG Guided Botox Injection for the Treatment of Non-Relaxing Puborectalis Syndrome|
- Change in symptoms based on scores using the PAC-SYM and Wexner Constipation questionnaires. [ Time Frame: Baseline to 6 months post-injection ]To assess whether Botox injections into the puborectalis muscle will improve patient's symptoms based on scores using the PAC-SYM and Wexner Constipation validated questionnaires at baseline, 2 weeks, 3 months, and 6 months post-Botox injection to determine severity of symptoms.
- Change in pressures on anal manometry [ Time Frame: Baseline to 3 months post-injection ]To assess the change in pressures on anal manometry before and after Botox injections into the puborectalis muscle at baseline and 3 months post-Botox injection.
- Change in quality of life based on scores using the PAC-QOL questionnaire. [ Time Frame: Baseline to 6 months post-Botox injection ]To assess whether Botox injections into the puborectalis muscle will improve patient's quality of life based on scores using the PAC-QOL validated questionnaire at 2 weeks, 3 months, and 6 months post-Botox injection.
- Change in the anorectal angle during defecation using defecography [ Time Frame: Baseline to 3 months post-injection ]To assess the change in the anorectal angle during defecation using defecography at baseline and 3 months after Botox injections into the puborectalis muscle
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||July 2014|
|Estimated Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
Experimental: Botulinum toxin (Botox) injection
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.
Drug: botulinum toxin
Other Name: Botox (Allergan, Irvine, CA)
Please refer to this study by its ClinicalTrials.gov identifier: NCT01780636
|Contact: Anthony Gaddi, MDemail@example.com|
|Contact: Samantha Reiter, MSfirstname.lastname@example.org|
|United States, California|
|University of California, Irvine Medical Center||Recruiting|
|Orange, California, United States, 92868|
|Principal Investigator: Karen Noblett, MD|
|Sub-Investigator: Anthony Gaddi, MD|
|Sub-Investigator: Felicia Lane, MD|
|Sub-Investigator: Stephanie Jacobs, MD|
|Sub-Investigator: Lauren Cadish, MD|
|Sub-Investigator: Allison Serra, MD|
|Principal Investigator:||Karen Noblett, MD||University of California, Irvine|