Non-relaxing Puborectalis Syndrome Clinical Trial
Official title:
Ultrasound and EMG Guided Botox Injection for the Treatment of Non-Relaxing Puborectalis Syndrome
| Verified date | October 2021 |
| Source | University of California, Irvine |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 7 |
| Est. completion date | July 2014 |
| Est. primary completion date | January 2014 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of California, Irvine Medical Center | Orange | California |
| Lead Sponsor | Collaborator |
|---|---|
| Karen Noblett | Allergan, American Urogynecologic Society |
United States,
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* Note: There are 15 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in Symptoms Based on Scores Using the PAC-SYM and Wexner Constipation Questionnaires. | 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 | |
| Primary | PAC-SYM and Wexner Scores | 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 | Change in Pressures on Anal Manometry | 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 |