Assessment of Rectal Sensibility * A Physiological Experiment Examining Urge in Patients with Fecal Incontinence

Assessment of Rectal Sensibility * A Physiological Experiment Examining Urge in Patients with Fecal Incontinence - Assessment of Rectal Sensibility

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON49506

Enrollment

Registered

2020-07-02

Start date

2020-07-01

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bowel incontinence Fecal incontinence

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Mentally competent adults - Complaints of faecal incontinence: defined as the uncontrolled passage of fecal material that occurred at least two to four times in a four-week period for the past six months (Rome IV criteria) (Researchprotocol page 12 - Study population)

Exclusion criteria

Exclusion criteria: 1. Complaints other than faecal incontinence, like for instance obstipation or diarrhea; 2. Anomalies (congenital,traumatic (other than birth trauma) and postsurgical); (Researchprotocol page 12 - Study population)

Design outcomes

Primary

Measure	Time frame
Minimally inflated balloon with attached weight: - Weight in grams to induce first urge Water-inflated balloon in seated position: - Volume in milliliters to induce first urge	—

Secondary

Measure	Time frame
Minimally inflated balloon with attached weight: - Weight in grams to induce first sensation - Weight in grams to induce desire to defecate - Weight in grams to induce maximum tolerable sensation Water-inflated balloon in seated position: - Volume in milliliters to induce first sensation - Volume in milliliters to induce desire to defecate - Volume in milliliters to induce maximum tolerable sensation Air-inflated balloon in left lateral position: - Volume in milliliters to induce first sensation - Volume in milliliters to induce first urge - Volume in milliliters to induce desire to defecate - Volume in milliliters to induce maximum tolerable sensation Water-inflated balloon in left lateral position: - Volume in milliliters to induce first sensation - Volume in milliliters to induce first urge - Volume in milliliters to induce desire to defecate - Volume in milliliters to induce maximum tolerable sensation Air-inflated balloon in seated position: - Volume in milliliters to induce first sensation - Volume in milliliters to induce first urge - Volume in milliliters to induce desire to defecate - Volume in milliliters to induce maximum tolerable sensation	—

Measure

Time frame

Minimally inflated balloon with attached weight: - Weight in grams to induce first sensation - Weight in grams to induce desire to defecate - Weight in grams to induce maximum tolerable sensation Water-inflated balloon in seated position: - Volume in milliliters to induce first sensation - Volume in milliliters to induce desire to defecate - Volume in milliliters to induce maximum tolerable sensation Air-inflated balloon in left lateral position: - Volume in milliliters to induce first sensation - Volume in milliliters to induce first urge - Volume in milliliters to induce desire to defecate - Volume in milliliters to induce maximum tolerable sensation Water-inflated balloon in left lateral position: - Volume in milliliters to induce first sensation - Volume in milliliters to induce first urge - Volume in milliliters to induce desire to defecate - Volume in milliliters to induce maximum tolerable sensation Air-inflated balloon in seated position: - Volume in milliliters to induce first sensation - Volume in milliliters to induce first urge - Volume in milliliters to induce desire to defecate - Volume in milliliters to induce maximum tolerable sensation

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Countries

Netherlands

Outcome results