New Diagnostic Tools in the Evaluation of the Posterior Compartment of the Women Pelvic Floor
NCT ID: NCT06525207
Last Updated: 2024-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
75 participants
OBSERVATIONAL
2024-09-01
2026-12-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Anal incontinence group
Women with anal incontinence and no symptoms of constipation
Impedance Planimetry, High-definition anorectal manometry and Pelvic Floor Ultrasonography
Global morpho-functional assessment of the anal sphincter complex using 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
Impedance Planimetry, High-definition anorectal manometry and Pelvic Floor Ultrasonography
Global morpho-functional assessment of the anal sphincter complex using Impedance Planimetry, High-definition anorectal manometry and Pelvic Floor Ultrasonography
Healthy volunteer group
Women without any defecation disorders
Impedance Planimetry, High-definition anorectal manometry and Pelvic Floor Ultrasonography
Global morpho-functional assessment of the anal sphincter complex using Impedance Planimetry, High-definition anorectal manometry and Pelvic Floor Ultrasonography
Interventions
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Impedance Planimetry, High-definition anorectal manometry and Pelvic Floor Ultrasonography
Global morpho-functional assessment of the anal sphincter complex using Impedance Planimetry, High-definition anorectal manometry and Pelvic Floor Ultrasonography
Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
18 Years
FEMALE
Yes
Sponsors
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Hospital Clinic of Barcelona
OTHER
Responsible Party
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Elizabeth Barba
Head of Neurogastroenterology and Motility section, Gastroenterology department
Locations
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Hospital Clínic of Barcelona
Barcelona, Barcelona, Spain
Countries
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References
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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.
Vollebregt 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.
Benezech 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.
Everist 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.
Taithongchai 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.
Other Identifiers
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HCB/2024/0523
Identifier Type: -
Identifier Source: org_study_id
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