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

October 5, 2021 updated by: Karen Noblett
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Orange, California, United States, 92868
        • University of California, Irvine Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Botox (Allergan, Irvine, CA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 from baseline to 6 months post-Botox injection to determine severity of symptoms. The PAC-SYM questionnaire unabbreviated title is Patient Assessment of Constipation-Symptoms and the total score is summed ranging from 0 to 44. The Wexner Constipation questionnaire total score is summed ranging from 0 to 30. Both questionnaires have higher values representing a worse outcome.
Baseline to 6 months post-injection
PAC-SYM and Wexner Scores
Time Frame: Baseline to 6 months
Scores on a scale The baseline scores were compared to scores at 6 months to evaluate the degree of improvement
Baseline to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pressures on Anal Manometry
Time Frame: Baseline to 6 months post-injection
To assess the change in pressures on anal manometry before and after Botox injections into the puborectalis muscle from baseline to 6 months post-Botox injection. Anal manometry is a test done in clinic to assess bowel function. Average resting pressure is recorded using the advanced diagnostic equipment. Above 40 mmHg is normal for resting pressure. Also, average squeeze pressure will be recorded. Greater than 100 mmHg is normal for average squeeze pressure.
Baseline to 6 months post-injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karen Noblett

Collaborators

Allergan
American Urogynecologic Society

Investigators

  • Principal Investigator: Karen Noblett, MD, University of California, Irvine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2013

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

January 25, 2013

First Submitted That Met QC Criteria

January 28, 2013

First Posted (Estimate)

January 31, 2013

Study Record Updates

Last Update Posted (Actual)

November 3, 2021

Last Update Submitted That Met QC Criteria

October 5, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALLERGAN-72570 HS# 2012-8750

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Non-relaxing Puborectalis Syndrome

Clinical Trials on botulinum toxin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saint Lucia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe