Trial Outcomes & Findings for Ultrasound and EMG Guided Botox Injection for the Treatment of Non-Relaxing Puborectalis Syndrome (NCT NCT01780636)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2/PHASE3

Target enrollment

7 participants

Primary outcome timeframe

Baseline to 6 months post-injection

Results posted on

2021-11-03

Participant Flow

Females over 18 were recruited from the URO/GYN and colorectal clinic. They have been diagnosed with non relaxing puborectalis syndrome.

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	7
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Botulinum Toxin (Botox) Injection n=7 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	55 YEARS n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 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.

Scores on a scale The baseline scores were compared to scores at 6 months to evaluate the degree of improvement

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome data not reported

Adverse Events

Botulinum Toxin (Botox) Injection

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Karen Noblett

UC Irvine

Phone: 714-456-6807

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place