Study of the Efficacy and Safety of Pediatric Pelvic Floor Muscle Probes

JRCT ID: jRCTs012230063

Registered date:11/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Anorectal malformation
• Date of first enrollment: 11/03/2024
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Patients will be underwent electromyography of the anal sphincter muscle using a newly developed pediatric pelvic floor muscle probe for research.

Outcome(s)

• Primary Outcome: Difference between the mean value of the myogenic potential of the anal sphincter at rest and the mean value of the myogenic potential of the anal sphincter during voluntary contraction

Secondary Outcome

(1) Correlation between the difference in myogenic potential of the anal sphincter at rest and during voluntary contraction and the difference in anal manometry
(2) Correlation between myogenic potential of the anal sphincter and anal manometry at rest
(3) Correlation between myogenic potential of the anal sphincter and anal manometry during voluntary contraction
(4) Sensitivity, specificity and AUC value of anal sphincter electromyography
(5) Relationship between anal sphincter electromyography and anal manometry and defecatory function score
(6) Relationship between anal sphincter electromyography and anal pressure test and defecatory function score
(7) Exploratory analysis to establish an evaluation method of anal function using anal pressure test values.
*The analysis items required for the development of the medical device shall be added sequentially.

Safety Outcome(s)
(1) Pain assessment associated with anal sphincter electromyography (Pain Rating Scale)
(2) Detalis and rate of adverse events of sphincter electromyography

Key inclusion & exclusion criteria

• Age minimum: >= 4age old
• Age maximum: < 16age old
• Gender: Both

Include criteria

Patients who meet all of the following criteria will be considered
(1) Patients who are at least 4 years old but less than 16 years old at the time of consent
(2) Patients who do not have a colostomy at the time of consent
(3) Persons who have received a full explanation of their participation in this study, and who have obtained the free and voluntary written consent of their surrogate after full understanding.

Exclude criteria

Patients who with any one of the following conditions will be excluded from the study.
(1) Patients who are unable to cooperation in anorectal examinations
(2) Patients who are unable to undergo rectal examination due to anal stenosis
(3) Patients with mental reterdation
(4) Patients with an implanted defibrillator or pacemaker
(5) Patients with a history of hypersensitivity to pelvic floor muscle probe materials or lubricants
(6) Other patients determined to be inappropriate as research patients by the principal investigator or subinvestigator

Related Information

• Primary Sponsor: Taketomi Akinobu
• Source(s) of Monetary Support: Sofken Co.Ltd.,FUJITA MEDICAL INSTRUMENTS CO.,LTD.,Digireha, Inc.