Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT07225803

Management of Dyssynergic Defecation

Led by Mayo Clinic · Updated on 2025-11-10

200

Participants Needed

1

Research Sites

206 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of this research is to better understand constipation and improve biofeedback treatments.

CONDITIONS

Official Title

Management of Dyssynergic Defecation

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Men and women aged 18-80 years who can provide written informed consent and comply with study requirements
  • Meet Rome III criteria for functional constipation and/or irritable bowel syndrome based on questionnaires
  • Have objective evidence of dyssynergic defecation on anorectal testing
Not Eligible

You will not qualify if you...

  • Significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric, or other diseases that may affect safety or study objectives
  • History of total, hemi-, or subtotal colectomy or abdominal surgery within 60 days before the study (segmental colon resection for diverticulitis allowed)
  • Current anal fissure
  • Significant structural abnormalities like rectocele larger than 4 cm, large enterocele, or full thickness rectal prolapse
  • Current or past colon or rectal cancer, scleroderma, inflammatory bowel disease, congenital anorectal abnormalities, solitary rectal ulcer syndrome, rectal resection, or pelvic irradiation
  • Pregnant or nursing women, prisoners, and institutionalized individuals
  • Body mass index over 35 kg/m2
  • Use of opioid analgesics or GLP-1 receptor agonists (must stop opioids at least 1 week before screening and stay off during study)
  • Current use of anticholinergics (e.g., amitriptyline, hyoscyamine) above low dose tricyclic antidepressants
  • Use of laxatives, linaclotide, lubiprostone, or prucalopride unless discontinued at least 3 days before screening and stayed off during study
  • Any other factors increasing risk or affecting data integrity

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Mayo Clinic

Rochester, Minnesota, United States, 55905

Actively Recruiting

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Research Team

K

Kelly J. Feuerhak, RN, CCRP

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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