Fecal IncontinenceFITNCT01778660
Standard Versus Mnemonic Counseling for Fecal Incontinence
A study testing Type of Counselling (Mnemonic) and Standard in people with Fecal Incontinence and Counselling, run by University of New Mexico at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fecal Incontinence, Counselling, Patient Satisfaction
- What is being tested?
- Type of Counselling (Mnemonic) and Standard
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Feb 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico
Albuquerque, New Mexico, 87131
About this study
Official title: Standard Versus Mnemonic Counseling for Fecal Incontinence: a Pilot Randomised Control Trial
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
- Being tested
- Type of Counselling (Mnemonic), Standard
- Keywords
- Fecal Incontinence, Treatment options, Patient Satisfaction
- Medical subject headings
- Fecal Incontinence, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Type of Counselling (Mnemonic)Other
StandardOther
| Study group | Role | What they receive |
|---|---|---|
| Standard Counselling | Active comparator | Patients in this arm are randomised to standard counselling. Receives: Other: Standard |
| Mnemonic Counselling | Experimental | Patients in this arm are randomised to counselling with the aid of a mnemonic. Receives: Other: Type of Counselling (Mnemonic) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recall
Patients will be asked to recall treatments recommended for fecal incontinence.
Measured: 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
Measured: Patients will complete this questionnaire following the physician counseling on day 1 of enrollment.
Modified Manchester
Measured: We are comparing the score change from after the physician counselling on day 1 of enrollment and at 2 month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2013 (estimated)
- Study startFeb 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fecal IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Cichowski, University of New Mexico
- Investigators
- Sara Cichowski, M.D., Principal investigator, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01778660
- Sponsor's protocol ID
- CTSC-12-429
- Other IDs
- CTSTC025-3
- Acronym
- FIT
- Status last verified
- Jan 2013
- First submitted
- 16 Jan 2013
- Last updated
- 8 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25932833
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standard Versus Mnemonic Counseling for Fecal Incontinence: a Pilot Randomised Control Trial
- ClinicalTrials.gov ID
- NCT01778660
- Acronym / sponsor ID
- FIT / CTSC-12-429
- Conditions
- Fecal Incontinence, Counselling, Patient Satisfaction
- Keywords
- Fecal Incontinence, Treatment options, Patient Satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 29 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Counselling | Active comparator | Other: StandardPatients in this arm are randomised to standard counselling. |
| Mnemonic Counselling | Experimental | Other: Type of Counselling (Mnemonic)Patients in this arm are randomised to counselling with the aid of a mnemonic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Type of Counselling (Mnemonic) | Other | Mnemonic Counselling |
| Standard | Other | Standard Counselling |
Primary outcome
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.
2 secondary outcomes
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2014.
- Derived from this study: PubMed 25932833Cichowski 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Cichowski, M.D. principal investigator
University of New Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Type of Counselling (Mnemonic) and Standard in people with Fecal Incontinence and Counselling, run by University of New Mexico at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recall (time frame: We are measuring the difference in recall the day of the physician counseling and 2 months after physician counselling). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01778660, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2014.