Anal IncontinenceNCT06525207
New Diagnostic Tools in the Evaluation of the Posterior Compartment of the Women Pelvic Floor
An observational study of Anal Incontinence and Obstructive Defecation, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
The goal of this observational study is to evaluate the pressure and distensibility index of the anal sphincter complex using high-definition anorectal manometry and the Impedance Planimetry system in women with fecal incontinence or constipation, as well as in a group of healthy volunteer women. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anal Incontinence, Obstructive Defecation
- What is being tested?
- Impedance Planimetry, High-definition anorectal manometry and Pelvic Floor Ultrasonography
- Type of treatment
- Medical device
- How many people
- 75 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2024to 1 Dec 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women presenting symptoms of posterior compartment pelvic floor dysfunction (such as anal incontinence or obstructive defecation) referred for anorectal manometry evaluation.
Who may be able to join
- Anal incontinence group: Women over 18 years old with predominantly fecal incontinence symptoms (St Mark > 6 points) and without constipation (KESS score < 10 points)
- Obstructive defecation group: Women over 18 years old with constipation symptoms and obstructive defecation (KESS score ≥ 10 points) and without fecal incontinence symptoms (St Mark < 1 point).
- Control group (healthy volunteers): Women over 18 years old without fecal incontinence (St Mark < 1 point) or constipation (KESS score < 10 points).
Who cannot join
- Anal incontinence and obstructive defecation groups: presence of anorectal tumors, ileo-anal/rectal anastomosis, previous anorectal surgeries (except primary repair of obstetric anal sphincter injury), anal stenosis, anal fistula, anal fissure, previous pelvic radiotherapy, use of opioids except loperamide, and history of inflammatory bowel disease (IBD).
- Control group (healthy volunteers): exclusion criteria are the same as for the patients groups and also include any volunteer with a history of systemic sclerosis, diabetes affecting target organs or insulin dependence, neurological conditions (stroke, multiple sclerosis, spinal cord injury, cauda equina syndrome, polyneuropathies), and history of pelvic floor disorder.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this observational study is to evaluate the pressure and distensibility index of the anal sphincter complex using high-definition anorectal manometry and the Impedance Planimetry system in women with fecal incontinence or constipation, as well as in a group of healthy volunteer women. The main questions it aims to answer are:
Assess the diagnostic accuracy of the Impedance Planimetry system compared to high-definition anorectal manometry (HD-ARM) in patients with anal incontinence and obstructive defecation.
Read more
Evaluate the diagnostic accuracy of three-dimensional reconstruction of the anal sphincter complex using HD-ARM to identify anal sphincter complex lesions compared to pelvic floor ultrasonography.
Determine the impact on the quality of life in women with anal incontinence and obstructive defecation based on the severity of symptoms assessed by validated scales
Participants will undergo the following tasks:
Undergo high-definition anorectal manometry and Impedance Planimetry testing.
Undergo pelvic floor ultrasonography to assess structural and functional aspects
Complete validated scales to assess symptoms and quality of life related to anal incontinence and obstructive defecation.
- Conditions
- Anal Incontinence, Obstructive Defecation
- Being tested
- Impedance Planimetry, High-definition anorectal manometry and Pelvic Floor Ultrasonography
- Keywords
- Impedance Planimetry, High Definition Anorectal Manometry
- Medical subject headings
- Encopresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impedance Planimetry, High-definition anorectal manometry and Pelvic Floor UltrasonographyDevice
Global morpho-functional assessment of the anal sphincter complex using Impedance Planimetry, High-definition anorectal manometry and Pelvic Floor Ultrasonography
| Study group | Role | What they receive |
|---|---|---|
| Anal incontinence group | Women with anal incontinence and no symptoms of constipation Receives: Device: Impedance Planimetry, High-definition anorectal manometry and Pelvic Floor Ultrasonography | |
| Obstructive defecation group | Women with constipation and predominant symptoms of obstructive defecation, without symptoms of anal incontinence Receives: Device: Impedance Planimetry, High-definition anorectal manometry and Pelvic Floor Ultrasonography | |
| Healthy volunteer group | Women without any defecation disorders Receives: Device: Impedance Planimetry, High-definition anorectal manometry and Pelvic Floor Ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the diagnostic accuracy of the Impedance Planimetry system in patients with anal incontinence, obstructive defecation and healthy women.
Assess the diagnostic accuracy of the Impedance Planimetry system by distensibility index of anal sphincter complex evaluated by the Impedance Planimetry system in patients with anal incontinence, obstructive defecation and healthy women.
Unit of Measure: Distensibility Index (mm^2/mmHg)
Measured: Baseline
Assess the diagnostic accuracy of the High-definition anorectal manometry in patients with anal incontinence, obstructive defecation and healthy women.
Assess the diagnostic accuracy of the High-definition anorectal manometry in patients with anal incontinence, obstructive defecation and healthy women.
Unit of Measure: Pressure (mmHg)
Measured: Baseline
Secondary outcomes (5)
Asses the diagnostic accuracy of the functional topographic images obtained from High-definition anorectal manometry.
Asses the diagnostic accuracy of sphincter disorders (descending perineum syndrome, rectal prolapse, intussusception and sphincter defects) using functional three-dimensional topographic images obtained from high-definition anorectal manometry compared with pelvic floor ultrasonography.
Measured: Baseline
Determine the impact on the quality of life in women with anal incontinence using the SF-12 questionnaire, based on the severity of the symptoms (St. Mark's score)
Determine the impact on the quality of life in women with anal incontinence using the SF-12 questionnaire, based on the severity of the symptoms (St. Mark's score)
Questionnaires:
- Short form 12 health survey questionnaire (SF-12). Range from 0 to 100, with higher scores mean better quality of life.
- St. Mark's incontinence score (St. Mark). Range from 0 to 24, with higher scores indicating worse symptom severity.
Measured: Baseline
Determine the impact on the quality of life in women with obstructive defecation using the SF-12 questionnaire, based on the severity of the symptoms (KESS score)
Determine the impact on the quality of life in women with obstructive defecation using the SF-12 questionnaire, based on the severity of the symptoms (KESS score)
Questionnaires:
- Short form 12 health survey questionnaire (SF-12). Range from 0 to 100, with higher scores mean better quality of life.
- Knowles-Eccersley-Scott-Symptom Constipation Score (KESS). Range from 0 to 39, with higher scores indicating worse symptom severity.
Measured: Baseline
Determine the impact on the quality of life in women with anal incontinence using the FIQLS questionnaire, based on the severity of the symptoms (St. Mark's score)
Determine the impact on the quality of life in women with anal incontinence using the FIQLS questionnaire, based on the severity of the symptoms (St. Mark's score)
Questionnaires:
- Fecal Incontinence Quality of Life Scale (FIQLS). Range from 29 to 116, with lower indicating a worse quality of life.
- St. Mark's incontinence score (St. Mark). Range from 0 to 24, with higher scores indicating worse symptom severity.
Measured: Baseline
Determine the impact on the quality of life in women with obstructive defecation using the CVE-20 questionnaire, based on the severity of the symptoms (KESS score)
Determine the impact on the quality of life in women with obstructive defecation using the CVE-20 questionnaire, based on the severity of the symptoms (KESS score)
Questionnaires:
- Quality of life specific questionnaire for constipated patients (CV-20). Range from 0 to 80, with higher scores mean better quality of life.
- Knowles-Eccersley-Scott-Symptom Constipation Score (KESS). Range from 0 to 39, with higher scores indicating worse symptom severity.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start1 Sep 2024
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Anal IncontinenceStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- 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
- 75 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Barba, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06525207
- Sponsor's protocol ID
- HCB/2024/0523
- Status last verified
- Oct 2024
- First submitted
- 17 Jul 2024
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Rezaie A, Iriana S, Pimentel M, Murrell Z, Fleshner P, Zaghiyan K. Can three-dimensional high-resolution anorectal manometry detect anal sphincter defects in patients with faecal incontinence? Colorectal Dis. 2017 May;19(5):468-475. doi: 10.1111/codi.13530.
PubMed 27657739Vollebregt PF, Rasijeff AMP, Pares D, Grossi U, Carrington EV, Knowles CH, Scott SM. Functional anal canal length measurement using high-resolution anorectal manometry to investigate anal sphincter dysfunction in patients with fecal incontinence or constipation. Neurogastroenterol Motil. 2019 Mar;31(3):e13532. doi: 10.1111/nmo.13532. Epub 2019 Jan 13.
PubMed 30637863Benezech A, Behr M, Bouvier M, Grimaud JC, Vitton V. Three-dimensional high-resolution anorectal manometry: does it allow automated analysis of sphincter defects? Colorectal Dis. 2015 Oct;17(10):O202-7. doi: 10.1111/codi.13017.
PubMed 26046765Everist R, Burrell M, Mallitt KA, Parkin K, Patton V, Karantanis E. Postpartum anal incontinence in women with and without obstetric anal sphincter injuries. Int Urogynecol J. 2020 Nov;31(11):2269-2275. doi: 10.1007/s00192-020-04267-8. Epub 2020 Mar 10.
PubMed 32157322Taithongchai A, Thakar R, Sultan AH. Management of subsequent pregnancies following fourth-degree obstetric anal sphincter injuries (OASIS). Eur J Obstet Gynecol Reprod Biol. 2020 Jul;250:80-85. doi: 10.1016/j.ejogrb.2020.04.063. Epub 2020 May 4.
PubMed 32408091
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Diagnostic Tools in the Evaluation of the Posterior Compartment of the Women Pelvic Floor
- ClinicalTrials.gov ID
- NCT06525207
- Acronym / sponsor ID
- HCB/2024/0523
- Conditions
- Anal Incontinence, Obstructive Defecation
- Keywords
- Impedance Planimetry, High Definition Anorectal Manometry
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 29 Jul 2024 (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 goal of this observational study is to evaluate the pressure and distensibility index of the anal sphincter complex using high-definition anorectal manometry and the Impedance Planimetry system in women with fecal incontinence or constipation, as well as in a group of healthy volunteer women. The main questions it aims to answer are:
Assess the diagnostic accuracy of the Impedance Planimetry system compared to high-definition anorectal manometry (HD-ARM) in patients with anal incontinence and obstructive defecation.
Evaluate the diagnostic accuracy of three-dimensional reconstruction of the anal sphincter complex using HD-ARM to identify anal sphincter complex lesions compared to pelvic floor ultrasonography.
Determine the impact on the quality of life in women with anal incontinence and obstructive defecation based on the severity of symptoms assessed by validated scales
Participants will undergo the following tasks:
Undergo high-definition anorectal manometry and Impedance Planimetry testing.
Undergo pelvic floor ultrasonography to assess structural and functional aspects
Complete validated scales to assess symptoms and quality of life related to anal incontinence and obstructive defecation.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anal incontinence group | – | Device: Impedance Planimetry, High-definition anorectal manometry and Pelvic Floor UltrasonographyWomen with anal incontinence and no symptoms of constipation |
| Obstructive defecation group | – | Device: Impedance Planimetry, High-definition anorectal manometry and Pelvic Floor UltrasonographyWomen with constipation and predominant symptoms of obstructive defecation, without symptoms of anal incontinence |
| Healthy volunteer group | – | Device: Impedance Planimetry, High-definition anorectal manometry and Pelvic Floor UltrasonographyWomen without any defecation disorders |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women presenting symptoms of posterior compartment pelvic floor dysfunction (such as anal incontinence or obstructive defecation) referred for anorectal manometry evaluation.
Key inclusion criteria (3 listed)
- Anal incontinence group: Women over 18 years old with predominantly fecal incontinence symptoms (St Mark > 6 points) and without constipation (KESS score < 10 points)
- Obstructive defecation group: Women over 18 years old with constipation symptoms and obstructive defecation (KESS score ≥ 10 points) and without fecal incontinence symptoms (St Mark < 1 point).
- Control group (healthy volunteers): Women over 18 years old without fecal incontinence (St Mark < 1 point) or constipation (KESS score < 10 points).
Key exclusion criteria (2 listed)
- Anal incontinence and obstructive defecation groups: presence of anorectal tumors, ileo-anal/rectal anastomosis, previous anorectal surgeries (except primary repair of obstetric anal sphincter injury), anal stenosis, anal fistula, anal fissure, previous pelvic radiotherapy, use of opioids except loperamide, and history of inflammatory bowel disease (IBD).
- Control group (healthy volunteers): exclusion criteria are the same as for the patients groups and also include any volunteer with a history of systemic sclerosis, diabetes affecting target organs or insulin dependence, neurological conditions (stroke, multiple sclerosis, spinal cord injury, cauda equina syndrome, polyneuropathies), and history of pelvic floor disorder.
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 |
|---|---|---|
| Impedance Planimetry, High-definition anorectal manometry and Pelvic Floor UltrasonographyGlobal morpho-functional assessment of the anal sphincter complex using Impedance Planimetry, High-definition anorectal manometry and Pelvic Floor Ultrasonography | Device | Anal incontinence group, Healthy volunteer group, Obstructive defecation group |
Primary outcome
Assess the diagnostic accuracy of the Impedance Planimetry system in patients with anal incontinence, obstructive defecation and healthy women.
Time frame: Baseline
Assess the diagnostic accuracy of the Impedance Planimetry system by distensibility index of anal sphincter complex evaluated by the Impedance Planimetry system in patients with anal incontinence, obstructive defecation and healthy women. Unit of Measure: Distensibility Index (mm^2/mmHg)
Assess the diagnostic accuracy of the High-definition anorectal manometry in patients with anal incontinence, obstructive defecation and healthy women.
Time frame: Baseline
Assess the diagnostic accuracy of the High-definition anorectal manometry in patients with anal incontinence, obstructive defecation and healthy women. Unit of Measure: Pressure (mmHg)
5 secondary outcomes
Asses the diagnostic accuracy of the functional topographic images obtained from High-definition anorectal manometry.
Time frame: Baseline
Determine the impact on the quality of life in women with anal incontinence using the SF-12 questionnaire, based on the severity of the symptoms (St. Mark's score)
Time frame: Baseline
Determine the impact on the quality of life in women with obstructive defecation using the SF-12 questionnaire, based on the severity of the symptoms (KESS score)
Time frame: Baseline
Determine the impact on the quality of life in women with anal incontinence using the FIQLS questionnaire, based on the severity of the symptoms (St. Mark's score)
Time frame: Baseline
Determine the impact on the quality of life in women with obstructive defecation using the CVE-20 questionnaire, based on the severity of the symptoms (KESS score)
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Results publication: PubMed 27657739Rezaie A, Iriana S, Pimentel M, Murrell Z, Fleshner P, Zaghiyan K. Can three-dimensional high-resolution anorectal manometry detect anal sphincter defects in patients with faecal incontinence? Colorectal Dis. 2017 May;19(5):468-475. doi: 10.1111/codi.13530.
- Results publication: PubMed 30637863Vollebregt PF, Rasijeff AMP, Pares D, Grossi U, Carrington EV, Knowles CH, Scott SM. Functional anal canal length measurement using high-resolution anorectal manometry to investigate anal sphincter dysfunction in patients with fecal incontinence or constipation. Neurogastroenterol Motil. 2019 Mar;31(3):e13532. doi: 10.1111/nmo.13532. Epub 2019 Jan 13.
- Results publication: PubMed 26046765Benezech A, Behr M, Bouvier M, Grimaud JC, Vitton V. Three-dimensional high-resolution anorectal manometry: does it allow automated analysis of sphincter defects? Colorectal Dis. 2015 Oct;17(10):O202-7. doi: 10.1111/codi.13017.
- Results publication: PubMed 32157322Everist R, Burrell M, Mallitt KA, Parkin K, Patton V, Karantanis E. Postpartum anal incontinence in women with and without obstetric anal sphincter injuries. Int Urogynecol J. 2020 Nov;31(11):2269-2275. doi: 10.1007/s00192-020-04267-8. Epub 2020 Mar 10.
- Results publication: PubMed 32408091Taithongchai A, Thakar R, Sultan AH. Management of subsequent pregnancies following fourth-degree obstetric anal sphincter injuries (OASIS). Eur J Obstet Gynecol Reprod Biol. 2020 Jul;250:80-85. doi: 10.1016/j.ejogrb.2020.04.063. Epub 2020 May 4.
- 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 Anal Incontinence and Obstructive Defecation, run by Hospital Clinic of Barcelona 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 2 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: under way, not looking for participants, as of the sponsor's last update on 9 Oct 2024. 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?
This study is still under way. Results are not available in the source record yet.
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?
Assess the diagnostic accuracy of the Impedance Planimetry system in patients with anal incontinence, obstructive defecation and healthy women. (time frame: Baseline). 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?
On the ClinicalTrials.gov record for NCT06525207, which also lists 5 linked publications.
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 9 Oct 2024.