Fecal IncontinenceMANOPRESSNCT05058326
Severity of Fecal Incontinence and Manometric Values Using the Anopress® Device in Women
An observational study of Fecal Incontinence and Anal; Sphincter, Incontinence, run by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta at 1 site in Spain.
Trial summary
The purpose of this study is to stablish a correlation between fecal incontinence severity scales (Wexner \& St. Mark's) and manometric values obtained using the Anopress® portable manometry and values obtained using endoanal ultrasound in women with fecal incontinence. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fecal Incontinence, Anal; Sphincter, Incontinence, Incontinence, Urge
- What is being tested?
- Portable endoanal manometry, Endoanal ultrasound and Incontinence severity scale questionaires
- How many people
- 41 participants
- Where
- 1 siteSpain
- Study dates
- 20 Sep 2020to 1 Oct 2021
- How long will I take part?
- 18 Months
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women over 18 years referred to our outpatient's clinic with the clinical diagnosis of fecal incontinence.
Who may be able to join
- Patients with the clinical diagnosis of fecal incontinence
- Age ≥ 18 years.
- Informed consent signed by the patient and the researcher.
Who cannot join
- Patients with psychiatric illnesses, addictions or any disorder that prevents understanding of the study.
- Inability to read or understand the questionnaires.
- Inability to read or understand any of the informed consent languages (Catalan, Spanish).
- Any patient who, due to his medical characteristics, presents a high individual risk when being included and completing the study.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitari Dr. Josep Trueta de Girona
Girona, Catalonia, 17007
About this study
The purpose of this study is to stablish a correlation between fecal incontinence severity scales (Wexner \& St. Mark's) and manometric values obtained using the Anopress® portable manometry and values obtained using endoanal ultrasound in women with fecal incontinence.
Read the detailed description
The Anopress® portable anal manometry will be used to measure the pressures of the anal canal in different phases: rest, squeeze, strain and endurance.
All female patients referred with the diagnosis of fecal incontinence giving written informed consent will undergo a endoanal portable manometry at our outpatients clinics. They will be asked to fill out the severity questionaries (Sant Mark's and Wexner). All data will be collected for analysis.
An endoanal ultrasound will be performed in all patients to assess the sphincter integrity.
- Being tested
- Portable endoanal manometry, Endoanal ultrasound, Incontinence severity scale questionaires
- Keywords
- Anal manometry, Anal portable manometry, Fecal incontinence severity, Endoanal ultrasound
- Medical subject headings
- Fecal Incontinence, Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Portable endoanal manometryDiagnostic test
Endoanal manometry values will be obtained using de Anopress® device. Fecal incontinence severity questionaries will be filled and collected.
Endoanal ultrasoundDiagnostic test
To assess the integrity of the anal canal.
Incontinence severity scale questionairesOther
Wexner and St. Mark's scales.
| Study group | Role | What they receive |
|---|---|---|
| TEST GROUP | Women with fecal incontinence referred to outpatients clinic. Receives: Diagnostic Test: Portable endoanal manometry; Diagnostic Test: Endoanal ultrasound; Other: Incontinence severity scale questionaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stablish a correlation between Wexner fecal incontinence severity scales and manometric values obtained using the Anopress® portable manometry in women with fecal incontinence
Spearman and Pearson correlation will be used to assess correlations between values
Measured: During the procedure
Stablish a correlation between St. Mark's fecal incontinence severity scales and manometric values obtained using the Anopress® portable manometry in women with fecal incontinence
Spearman and Pearson correlation will be used to assess correlations between values
Measured: During the procedure
Secondary outcomes (2)
Stablish a correlation between St.Mark's fecal incontinence severity scales and values obtained using endoanal ultrasound in women with fecal incontinence
Spearman and Pearson correlation will be used to assess correlations between values
Measured: During the procedure
Stablish a correlation between Wexner fecal incontinence severity scales and values obtained using endoanal ultrasound in women with fecal incontinence
Spearman and Pearson correlation will be used to assess correlations between values
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start20 Sep 2020
- Primary completion1 Oct 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05058326
- Sponsor's protocol ID
- 052020
- Acronym
- MANOPRESS
- Status last verified
- Mar 2022
- First submitted
- 13 Sep 2021
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Severity of Fecal Incontinence and Manometric Values Using the Anopress® Device in Women
- ClinicalTrials.gov ID
- NCT05058326
- Acronym / sponsor ID
- MANOPRESS / 052020
- Keywords
- Anal manometry, Anal portable manometry, Fecal incontinence severity, Endoanal ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Institut d'Investigació Biomèdica de Girona Dr. Josep TruetaUniversity, hospital or other
- Study start
- 20 Sep 2020 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 27 Sep 2021 (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.
The purpose of this study is to stablish a correlation between fecal incontinence severity scales (Wexner \& St. Mark's) and manometric values obtained using the Anopress® portable manometry and values obtained using endoanal ultrasound in women with fecal incontinence.
Detailed description
The Anopress® portable anal manometry will be used to measure the pressures of the anal canal in different phases: rest, squeeze, strain and endurance.
All female patients referred with the diagnosis of fecal incontinence giving written informed consent will undergo a endoanal portable manometry at our outpatients clinics. They will be asked to fill out the severity questionaries (Sant Mark's and Wexner). All data will be collected for analysis.
An endoanal ultrasound will be performed in all patients to assess the sphincter integrity.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 18 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TEST GROUP | – | Diagnostic Test: Portable endoanal manometry, Diagnostic Test: Endoanal ultrasound, Other: Incontinence severity scale questionairesWomen with fecal incontinence referred to outpatients clinic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women over 18 years referred to our outpatient's clinic with the clinical diagnosis of fecal incontinence.
Key inclusion criteria (3 listed)
- Patients with the clinical diagnosis of fecal incontinence
- Age ≥ 18 years.
- Informed consent signed by the patient and the researcher.
Key exclusion criteria (4 listed)
- Patients with psychiatric illnesses, addictions or any disorder that prevents understanding of the study.
- Inability to read or understand the questionnaires.
- Inability to read or understand any of the informed consent languages (Catalan, Spanish).
- Any patient who, due to his medical characteristics, presents a high individual risk when being included and completing the study.
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 |
|---|---|---|
| Portable endoanal manometryEndoanal manometry values will be obtained using de Anopress® device. Fecal incontinence severity questionaries will be filled and collected. | Diagnostic test | TEST GROUP |
| Endoanal ultrasoundTo assess the integrity of the anal canal. | Diagnostic test | TEST GROUP |
| Incontinence severity scale questionairesWexner and St. Mark's scales. | Other | TEST GROUP |
Primary outcome
Stablish a correlation between Wexner fecal incontinence severity scales and manometric values obtained using the Anopress® portable manometry in women with fecal incontinence
Time frame: During the procedure
Spearman and Pearson correlation will be used to assess correlations between values
Stablish a correlation between St. Mark's fecal incontinence severity scales and manometric values obtained using the Anopress® portable manometry in women with fecal incontinence
Time frame: During the procedure
Spearman and Pearson correlation will be used to assess correlations between values
2 secondary outcomes
Stablish a correlation between St.Mark's fecal incontinence severity scales and values obtained using endoanal ultrasound in women with fecal incontinence
Time frame: During the procedure
Stablish a correlation between Wexner fecal incontinence severity scales and values obtained using endoanal ultrasound in women with fecal incontinence
Time frame: During the procedure
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 31 Mar 2022.
- Individual participant dataSharing planned: No
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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 Anal; Sphincter, Incontinence, run by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta at 1 site in Spain.
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 3 inclusion and 4 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 31 Mar 2022. 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 Spain. 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?
Stablish a correlation between Wexner fecal incontinence severity scales and manometric values obtained using the Anopress® portable manometry in women with fecal incontinence (time frame: During the procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Mar 2022.