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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University of California, Irvine
Sponsor:
Collaborators:
American Urogynecologic Society
Allergan
Information provided by (Responsible Party):
Samantha Reiter, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT01780636
First received: January 25, 2013
Last updated: January 28, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Non-relaxing Puborectalis Syndrome
Drug: botulinum toxin
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • Change in symptoms based on scores using the PAC-SYM and Wexner Constipation questionnaires. [ Time Frame: Baseline to 6 months post-injection ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change in pressures on anal manometry [ Time Frame: Baseline to 3 months post-injection ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Change in quality of life based on scores using the PAC-QOL questionnaire. [ Time Frame: Baseline to 6 months post-Botox injection ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    To assess the change in the anorectal angle during defecation using defecography at baseline and 3 months after Botox injections into the puborectalis muscle


Estimated Enrollment: 30
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)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01780636

Contacts
Contact: Anthony Gaddi, MD 714-456-8564 tgaddi@uci.edu
Contact: Samantha Reiter, MS 714-456-6846 reiters@uci.edu

Locations
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         
Sponsors and Collaborators
University of California, Irvine
American Urogynecologic Society
Allergan
Investigators
Principal Investigator: Karen Noblett, MD University of California, Irvine
  More Information

Additional Information:
Publications:

Responsible Party: Samantha Reiter, Karen Noblett, MD, University of California, Irvine
ClinicalTrials.gov Identifier: NCT01780636     History of Changes
Other Study ID Numbers: ALLERGAN-72570
Study First Received: January 25, 2013
Last Updated: January 28, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, Irvine:
Non relaxing puborectalis syndrome
Botulinum toxin A
Botox
Constipation

Additional relevant MeSH terms:
Botulinum Toxins
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014