A Study to Assess Anal Pressures by Manometry in Health People

Overview

About this study

The specific aims of this study are to measure recto-anal pressures measured by portable manometry at rest, during squeeze, during simulated evacuation, rectal distention, and during a Valsalva maneuver in asymptomatic healthy women and men.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  1. Do not meet symptom-based criteria for constipation, fecal incontinence or irritable bowel syndrome by validated questionnaires
  2. Able to provide written informed consent before participating in the study
  3. Able to communicate adequately with the investigator and to comply with the requirements for the entire study.

Exclusion Criteria

  1. BMI ≥ 30 kg/m²
  2. Clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric or other disease that may interfere with the objectives of the study and/or pose safety concerns.
  3. During digital rectal examination, markedly reduced anal contractile response or perineal descent during simulated evacuation.
  4. Medications that may alter gastrointestinal motility, e.g., serotoninergic agents, alpha adrenergic agonists or antagonists, calcium channel blockers or opiates.
  5. Prior pelvic radiation; history of or current inflammatory bowel disease
  6. Putative risk factors for pelvic floor trauma, i.e. > 4 vaginal deliveries, known birthweight >4500 gms (Macrosomia), known 4th degree perineal tear, or known forceps use.
  7. Any anorectal procedures (including for hemorrhoids)

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Adil Bharucha, M.B.B.S., M.D.

Closed for enrollment

Contact information:

Kelly Feuerhak CCRP

(507)255-6802

Feuerhak.Kelly@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

.
CLS-20402163

Mayo Clinic Footer