Non-relaxing Puborectalis Syndrome
Conditions
Keywords
Non relaxing puborectalis syndrome, Botulinum toxin A, Botox, Constipation
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.
Interventions
DRUGbotulinum toxin
Sponsors
American Urogynecologic Society
Allergan
Karen Noblett
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Symptoms Based on Scores Using the PAC-SYM and Wexner Constipation Questionnaires. | 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. |
| PAC-SYM and Wexner Scores | Baseline to 6 months | Scores on a scale The baseline scores were compared to scores at 6 months to evaluate the degree of improvement |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pressures on Anal Manometry | 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. |
Countries
United States
Participant flow
Recruitment details
Females over 18 were recruited from the URO/GYN and colorectal clinic. They have been diagnosed with non relaxing puborectalis syndrome.
Participants by arm
| Arm | Count |
|---|---|
| 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.
botulinum toxin | 7 |
| Total | 7 |
Baseline characteristics
| Characteristic | Botulinum Toxin (Botox) Injection |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Age, Continuous | 55 YEARS |
| Region of Enrollment United States | 7 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 7 |
| other Total, other adverse events | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 |
Outcome results
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.
Time frame: Baseline to 6 months post-injection
Population: All females between the ages of 40-75 and data was insufficient to analyze as target enrollment was not met and terminated due to poor recruitment. The data for this outcome measure was not collected.
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
Time frame: Baseline to 6 months
Population: All 7 received Botox and data was insufficient to analyze as target enrollment was not met and terminated due to poor recruitment. The data for this outcome measure was not collected.
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.
Time frame: Baseline to 6 months post-injection
Population: All female between ages 40-75. Data was insufficient to analyze as target enrollment was not met and terminated due to poor recruitment. The data for this outcome measure was not collected.