Validation of anal function assessment indices using a simultaneous electromyography and manometry device, and exploratory evaluation of a home-based anorectal training model in postoperative patients with anorectal malformation and Hirschsprung disease: a multicenter, open-label, single-arm specified clinical study (ARMHD-BFApp02)
Exploratory study of anal function assessment and home-based anorectal training in postoperative patients with anorectal malformation and Hirschsprung disease
Ara Momoko
Hokkaido University Hospital
Kita 14 Nishi 5, Kita-ku, Sapporo, Hokkaido, Japan
+81-11-706-5927
crbs2601_armhd-bfapp02@pop.med.hokudai.ac.jp
Imaizumi Ken
Hokkaido University Hospital
Kita 14 Nishi 5, Kita-ku, Sapporo, Hokkaido, Japan
+81-11-706-7931
crbs2601_armhd-bfapp02@pop.med.hokudai.ac.jp
Recruiting
Sept. 07, 2026
40
Interventional
non-randomized controlled trial
open(masking not used)
uncontrolled control
single assignment
diagnostic purpose
Inclusion Criteria:
1. Participants who have undergone definitive surgery for anorectal malformation or Hirschsprung disease
2. Participants who are 4 years of age or older and younger than 16 years of age at the time informed consent is obtained.
3. Participants who do not have a stoma at the time informed consent is obtained.
4. Participants from whom written informed consent has been voluntarily obtained from their legally acceptable representative, after sufficient explanation and understanding regarding participation in this study.
5. Participants who have received an explanation appropriate to their age and level of understanding, and from whom assent to study participation has been obtained to the extent possible.
For participation in Cohort 2, in addition to the above, participants must meet all of the following criteria at enrollment:
1. Participants with fecal incontinence occurring at least once per week.
2. Participants from whom additional consent for participation in the home-based anorectal function training program has been obtained from both the participant and their legally acceptable representative.
3. Participants who have a home environment in which they can perform home-based anorectal function training for 1 minute or more and less than 5 minutes per session, 1 to 3 times per day, for 28 days.
4. Participants who, with the support of a parent or guardian, are able to record training implementation, receive assistance with device operation, and undergo safety monitoring.
5. Participants who are judged by the investigator to be able to safely and continuously perform the home-based training.
Exclusion Criteria:
1. Participants who are unable to cooperate with anal examination or the measurements specified in this study.
2. Participants in whom safe digital rectal examination or safe insertion of the probe and performance of the measurements are difficult because of anal stenosis or other anatomical reasons.
3. Participants who are judged to have marked difficulty in understanding or completing the study procedures, even after taking their age or developmental stage into consideration.
4. Participants with an implantable cardioverter-defibrillator, pacemaker, or sacral nerve stimulation device.
5. Participants with a history of hypersensitivity to the material of the pelvic floor probe or to the lubricant.
6. Participants who have participated within the past 90 days in another interventional study involving an investigational device, investigational drug, or any other intervention that could affect the evaluation of this study.
7. Participants for whom initiation of new bowel function training, biofeedback therapy, or any other intervention that may substantially affect the evaluation of this study is planned during the study period, or whose current management is expected to change in such a way at the start of the study.
8. Participants who are otherwise judged by the principal investigator or subinvestigator to be inappropriate for inclusion in the study from the standpoint of safety or validity of assessment.
For Cohort 2, in addition to the above, participants meeting any of the following criteria will be excluded:
1. Participants who have difficulty operating the home training device or related application and are not expected to be able to use them appropriately even with assistance from their legally acceptable representative or others.
2. Participants for whom it is not possible to ensure recording of training implementation status or a system for reporting adverse events.
3. Participants who are judged by the investigator to have a home environment or living circumstances in which home-based training would impose an excessive burden.
4age old over
16age old not
Both
Anorectal malformation and Hirschsprung disease
Cohort 1: Anorectal function assessment using an unapproved simultaneous electromyography-manometry device (procedural assessment intervention). Cohort 2: In addition to the above assessments, a 4-week home-based anorectal function training intervention using a dedicated biofeedback therapy support application.
simultaneous electromyography-manometry, anorectal function assessment, biofeedback, home-based anorectal function training, mobile application
D000071056; D006627
D004576; D008365; D001676; D063731
Correlation coefficient between intra-anal electromyographic activity and intra-anal pressure during anal contraction.
1. Endpoints related to anorectal function testing
Electromyographic values and intra-anal pressure values during anal contraction and at rest, measured using the simultaneous electromyography-manometry device
Phase difference between intra-anal electromyographic activity and intra-anal pressure measured using the simultaneous electromyography-manometry device
Correlation of measurements obtained with the simultaneous electromyography-manometry device and those obtained with conventional devices (electromyography and anorectal manometry)
Duration of sustained contraction
Reproducibility of measurements based on repeated assessments (test-retest reliability)
2. Endpoints related to associations with clinical indicators
Association between device-derived measurement indices and bowel function-related indicators
Indices based on the bowel diary
Number of days with fecal incontinence
Number of episodes of underwear staining
Number of incontinence episodes
Patient-reported outcomes (JASGAP, Bowel Function Score, and PedsQL 4.0 SF15)
3. Longitudinal changes under usual care (Cohort 1)
Changes in bowel function-related indicators and device-derived measurement indices at enrollment and 28 days later.
4. Efficacy of home-based anorectal function training (Cohort 2)
Changes in fecal incontinence-related indicators, patient-reported outcomes, and device-derived measurement indices (e.g., electromyographic values, pressure values, and phase difference) before and after the intervention.
5. Intervention exposure to home-based anorectal function training (Cohort 2)
Usage log data on implementation of home-based anorectal function training, including number of training sessions, duration of training, and content of each session, will be collected and evaluated.
