By InvitationNot Applicable

Rectal Evacuation Disorders and Straining-associated Symptoms in Bleeding Hemorrhoids

United States100 participantsStarted 2025-12-05

Plain-language summary

This study aims to understand the mechanisms of straining on anorectal testing, to better help people receive more effective treatment advice. The study also aims to understand how point-of-care anorectal testing with an FDA-cleared device called Rectal Expulsion Device (RED) helps to identify people that might benefit from specific treatments that target pelvic floor muscle problems that lead to straining and hemorrhoids.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * Participants had a colonoscopy within the last 12 months for rectal bleeding (with no cause of bleeding found other than hemorrhoids). * Participants provider placed an order for anorectal manometry to the University of Michigan Exclusion Criteria: * Anal fissure * Pregnancy

What they're measuring

Intra-class correlation (ICC) between overall Patient Assessment of Constipation Symptom Score (PAC-SYM) and Hemorrhoid Disease Symptom Score (HDSS) sum scores

Timeframe: Day 1 (standard of care clinic visit)

Trial details

NCT IDNCT07161765

SponsorUniversity of Michigan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09

View on ClinicalTrials.gov More Bleeding Hemorrhoids trials