Standard Versus Mnemonic Counseling for Fecal Incontinence

Not Applicable

Completed

• Conditions: Counselling; Fecal Incontinence; Patient Satisfaction
• Interventions: Other: Standard; Other: Type of Counselling (Mnemonic)

• Registration Number: NCT01778660
• Lead Sponsor: University of New Mexico

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-01
• Study First Submitted: 2013-01-16
• Study First Submitted QC: 2013-01-28
• Study First Posted: 2013-01-29
• Study Start: 2013-02
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Last Update Submitted: 2014-04-04
• Last Update Posted: 2014-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Counselling	Standard	Patients in this arm are randomised to standard counselling.
Mnemonic Counselling	Type of Counselling (Mnemonic)	Patients in this arm are randomised to counselling with the aid of a mnemonic.

Primary Outcome Measures

Name	Time	Method
Recall	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 Outcome Measures

Name	Time	Method
Questionare on the Quality of the Physician and Patient Interaction	Patients will complete this questionnaire following the physician counseling on day 1 of enrollment.
Modified Manchester	We are comparing the score change from after the physician counselling on day 1 of enrollment and at 2 month follow-up.

Trial Locations

Locations (1)

University of New Mexico; 🇺🇸 Albuquerque, New Mexico, United States