Clinical trial NCT01780636: Ultrasound and EMG Guided Botox Injection for the Treatment of Non-Relaxing Puborectalis Syndrome
Official title: Ultrasound and EMG Guided Botox Injection for the Treatment of Non-Relaxing Puborectalis Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Non-relaxing Puborectalis Syndrome
Keywords: Non relaxing puborectalis syndrome
Botulinum toxin A
Botox
Constipation
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: American Urogynecologic Society
name: Allergan
First posted: 2013-01-31
Enrollment: 7
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility 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

Primary outcomes:
measure: Change in Symptoms Based on Scores Using the PAC-SYM and Wexner Constipation Questionnaires.
timeFrame: Baseline to 6 months post-injection
measure: PAC-SYM and Wexner Scores
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Change in Pressures on Anal Manometry
timeFrame: Baseline to 6 months post-injection
Other outcomes:
Locations:
city: Orange
country: United States
facility: University of California, Irvine Medical Center
state: California
Study officials:
affiliation: University of California, Irvine
name: Karen Noblett, MD
role: PRINCIPAL_INVESTIGATOR
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