Standard Versus Mnemonic Counseling for Fecal Incontinence

NCT01778660 | Completed

• 2 other identifiers: CTSC-12-429CTSTC025-3
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Fecal Incontinence; Counselling; Patient Satisfaction

Keywords

Fecal Incontinence; Treatment options; Patient Satisfaction

Outcome Measures

Primary Outcomes (1)

• Recall

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

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

Secondary Outcomes (2)

• 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.

Study Arms (2)

Standard Counselling

ACTIVE COMPARATOR

Patients in this arm are randomised to standard counselling.

Other: Standard

Mnemonic Counselling

EXPERIMENTAL

Patients in this arm are randomised to counselling with the aid of a mnemonic.

Other: Type of Counselling (Mnemonic)

Interventions

Type of Counselling (Mnemonic) OTHER

Mnemonic Counselling

Standard OTHER

Standard Counselling

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of New Mexico: lead

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

Related Publications (1)

• Cichowski SB, Dunivan GC, Rogers RG, Murrietta AM, Komesu YM. Standard compared with mnemonic counseling for fecal incontinence: a randomized controlled trial. Obstet Gynecol. 2015 May;125(5):1063-1070. doi: 10.1097/AOG.0000000000000755.

  PMID: 25932833 DERIVED

MeSH Terms

Conditions

Fecal Incontinence; Patient Satisfaction

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Sara Cichowski, M.D.

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 16, 2013
• First Posted: January 29, 2013
• Study Start: February 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: April 8, 2014

Record last verified: 2013-01

Locations

US (1)