Healthy
Conditions
Keywords
ARM procedure, ARM measurement, asymptomatic, Healthy, anorectal function, anorectal
Brief summary
The research study will be conducted to obtain baseline, or "normative" information to compare an air charged HRAM catheter to traditional solid catheter measures using the IAPWG standardized testing protocol and London classification.
Detailed description
The primary purpose of this research study is to obtain normative datasets for traditional measures of anorectal function with an air charged HRAM catheter in healthy subjects using the IAPWG standardized testing protocol and London classification for anorectal manometry (ARM) measurement. A secondary purpose is to qualitatively compare the performance of air charged and solid state HRAM catheters in determining values for traditional measures of anorectal function in a subset of study subjects using the IAPWG standardized testing protocol and London classification for ARM measurement.
Interventions
DIAGNOSTIC_TESTAir Charged Catheter ARM Procedure
Normative datasets for traditional measures of anorectal function with an air charged HRAM catheter will be collected in healthy subjects using the IAPWG standardized testing protocol and London classification for ARM measurement.
DIAGNOSTIC_TESTSolid State Catheter ARM Procedure
Normative datasets for traditional measures of anorectal function with a solid state HRAM catheter will be collected in some healthy subjects using the IAPWG standardized testing protocol and London classification for ARM measurement for comparison to the air charged catheter.
Sponsors
Laborie Medical Technologies Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 1\. Male and female volunteers, 18-65 years old * 2\. Willing to provide informed consent * 3\. Willing and able to follow instructions for ARM procedure
Exclusion criteria
* 1\. Documented history of gastrointestinal disorders such as: * a. fecal incontinence, * b. irritable bowel syndrome (IBS), * c. functional constipation, as defined by two or more of these symptoms for at least 25% of the time over the past 3 months: * i. excessive straining, * ii. hard or lumpy stools, * iii. sensation of incomplete evacuation, * iv. a feeling of anorectal blockage, * v. manual maneuvers to facilitate defecation, * vi. or fewer than 3 bowel movements per week. * d. functional diarrhea, as defined by the following symptoms over the past 3 months: * i. Loose or watery stools * ii. Lack of pain with diarrhea * iii. Diarrhea occurring in at least 75% of bowel movements * iv. No identifiable causes * 2\. Use of medications that may affect gastrointestinal motility as determined by healthcare professional. * 3\. Prior pelvic radiation, * 4\. Prior anorectal surgical procedures, including treatment for hemorrhoids, * 5\. Risk factors for pelvic floor trauma: * a. more than 4 vaginal deliveries, * b. vaginal delivery with birthweight greater than 4500gms (macrosomia), * c. known 4th degree perineal tear or known forceps use during delivery. * 6\. Contraindicated for ARM testing * 7\. Has gastrointestinal symptoms and is indicated for ARM testing * 8\. Subject is currently pregnant or plans to become pregnant during the course of their enrollment in the study, as self-reported.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement Performance of Air Charged Catheter in cm | Day 1 | Functional anal canal length, cm, as measured by the air charged catheter |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measurement Performance of Solid State Catheter in cm | Day 1 | Functional anal canal length, cm, as measured by a solid state catheter |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 41.47 years STANDARD_DEVIATION 12.033 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 62 Participants |
| Region of Enrollment United States | 81 participants |
| Sex: Female, Male Female | 60 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 81 |
| other Total, other adverse events | 0 / 81 |
| serious Total, serious adverse events | 0 / 81 |
Outcome results
None listed