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Completed

NCT Number: NCT01778660

Standard Versus Mnemonic Counseling for Fecal Incontinence

This study compares standard versus mnemonic counseling for the treatment of fecal incontinence. A mnemonic is a word or rhyme used to aid memory. Our hypothesis is that women randomised to mnemonic counseling will higher recall of treatments, satisfaction with the physician visit and greater improvement in their quality of life when compared to women who received standard counseling.

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Key information

Conditions

Fecal Incontinence Behavior Counselling Digestive System Diseases Gastrointestinal Diseases Health Behavior Intestinal Diseases Patient Satisfaction Rectal Diseases Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Over 18 years of age
  • Diagnosed with fecal incontinence by on of the attending physicians
  • Bothersome fecal incontinence symptoms for at least 3 months
  • Able to give informed consent
  • Able to speak, read and comprehend English

Exclusion criteria

  • Younger than 18 years
  • Fecal Incontinence <3 months
  • Unable to give informed consent
  • Unable to speak, read and comprehend English
  • Diagnosis of active colorectal or anal malignancy, inflammatory bowel disease, recto-vaginal fistula, and rectal prolapse

Treatment and study plan

Type of Counselling (Mnemonic)

Other

standard

Other

Primary outcomes

  1. Recall

    Time frame: We are measuring the difference in recall the day of the physician counseling and 2 months after physician counselling

    Patients will be asked to recall treatments recommended for fecal incontinence.

Secondary outcomes

  1. Questionare on the Quality of the Physician and Patient Interaction

    Time frame: Patients will complete this questionnaire following the physician counseling on day 1 of enrollment.

  2. Modified Manchester

    Time frame: We are comparing the score change from after the physician counselling on day 1 of enrollment and at 2 month follow-up.

Sponsors and collaborators

Lead sponsor

University of New Mexico

Other

Registry information

Official study title

Standard Versus Mnemonic Counseling for Fecal Incontinence: a Pilot Randomised Control Trial

Acronym: FIT

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 29, 2013
Registry last updated
Apr 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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