Fecal IncontinenceNCT05755763
Validity and Reliability of the Turkish St. Marks Incontinence Score
An observational study of Fecal Incontinence and Pelvic Floor Disorders, run by Atlas University at 1 site in Turkey (Türkiye).
Trial summary
For the Turkish validity and reliability study of St.Mark's (Vaizey) Incontinence Score, which consists of 7 questions, it will be applied to 65 people diagnosed with anal incontinence after it is translated by translation-retranslation method. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fecal Incontinence, Pelvic Floor Disorders
- What is being tested?
- Anal incontinence patients with St. Mark's Incontinence Score
- How many people
- 65 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Feb 2023to 10 Mar 2023
- Phase
- Observational
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients over the age of 18 who were diagnosed with anal incontinence in our clinic will be included in the study. Persons who have difficulties in understanding and writing Turkish will be excluded from the study. Patients will fill out the St. Mark's Incontinence Score.
Who may be able to join
- people with the complatint of anal incontinence
- being volunteered to participate
Who cannot join
- having difficulties in understanding and speaking Turkish
Trial locations and contacts
1 site in 1 country.
About this study
For the Turkish validity and reliability study of St.Mark's (Vaizey) Incontinence Score, which consists of 7 questions, it will be applied to 65 people diagnosed with anal incontinence after it is translated by translation-retranslation method.
- Conditions
- Fecal Incontinence, Pelvic Floor Disorders
- Being tested
- Anal incontinence patients with St. Mark's Incontinence Score
- Medical subject headings
- Fecal Incontinence, Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anal incontinence patients with St. Mark's Incontinence ScoreOther
The scale was applied to the patients who applied to our clinic with the diagnosis of anal incontinence.
What is being measured
The primary outcome is the main question the study is designed to answer.
Turkish Validation and Reliability of St. Mark's Incontinence Score
St. Mark's Incontinence Score which shows the disease severity of anal incontinence patients and is used in the follow-up of their recovery status. The Turkish validity and reliability study of Mark's incontinence score will be conducted and it will be translated into Turkish.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start7 Feb 2023
- Primary completion8 Mar 2023
- Study completion10 Mar 2023
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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atlas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin Ecem Temel Pekmez, Atlas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05755763
- Sponsor's protocol ID
- YETPekmez
- Status last verified
- Mar 2023
- First submitted
- 23 Feb 2023
- Last updated
- 23 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ersoy O, Ecem Temel Y. Validity and Reliability of the Turkish St. Mark's Incontinence Score. Turk J Gastroenterol. 2026 Feb 19;37(4):448-454. doi: 10.5152/tjg.2026.25551.
PubMed 41942390
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of the Turkish St. Marks Incontinence Score
- ClinicalTrials.gov ID
- NCT05755763
- Acronym / sponsor ID
- YETPekmez
- Conditions
- Fecal Incontinence, Pelvic Floor Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Atlas UniversityUniversity, hospital or other
- Study start
- 7 Feb 2023 (actual)
- Primary completion
- 8 Mar 2023 (actual)
- Study completion
- 10 Mar 2023 (actual)
- First posted
- 6 Mar 2023 (actual)
- 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.
For the Turkish validity and reliability study of St.Mark's (Vaizey) Incontinence Score, which consists of 7 questions, it will be applied to 65 people diagnosed with anal incontinence after it is translated by translation-retranslation method.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over the age of 18 who were diagnosed with anal incontinence in our clinic will be included in the study. Persons who have difficulties in understanding and writing Turkish will be excluded from the study. Patients will fill out the St. Mark's Incontinence Score.
Key inclusion criteria (2 listed)
- people with the complatint of anal incontinence
- being volunteered to participate
Key exclusion criteria (1 listed)
- having difficulties in understanding and speaking Turkish
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 |
|---|---|---|
| Anal incontinence patients with St. Mark's Incontinence ScoreThe scale was applied to the patients who applied to our clinic with the diagnosis of anal incontinence. | Other | – |
Primary outcome
Turkish Validation and Reliability of St. Mark's Incontinence Score
Time frame: 1 month
St. Mark's Incontinence Score which shows the disease severity of anal incontinence patients and is used in the follow-up of their recovery status. The Turkish validity and reliability study of Mark's incontinence score will be conducted and it will be translated into Turkish.
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 23 Mar 2023.
- Derived from this study: PubMed 41942390Ersoy O, Ecem Temel Y. Validity and Reliability of the Turkish St. Mark's Incontinence Score. Turk J Gastroenterol. 2026 Feb 19;37(4):448-454. doi: 10.5152/tjg.2026.25551.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fecal Incontinence and Pelvic Floor Disorders, run by Atlas University at 1 site in Turkey (Türkiye).
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 2 inclusion and 1 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 23 Mar 2023. 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 Turkey (Türkiye). 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?
Turkish Validation and Reliability of St. Mark's Incontinence Score (time frame: 1 month). 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 NCT05755763, 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 23 Mar 2023.