New Diagnostic Tools in the Evaluation of the Posterior Compartment of the Women Pelvic Floor

NCT06525207 | Active Not Recruiting FDA Device

• 1 other identifier: HCB/2024/0523
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Anal Incontinence; Obstructive Defecation

Keywords

Impedance Planimetry; High Definition Anorectal Manometry

Outcome Measures

Primary Outcomes (2)

• 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)

  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)

  Baseline

Secondary Outcomes (5)

• Asses the diagnostic accuracy of the functional topographic images obtained from High-definition anorectal manometry.

  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)

  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)

  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)

  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)

  Baseline

Study Arms (3)

Anal incontinence group

Women with anal incontinence and no symptoms of constipation

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

Device: Impedance Planimetry, High-definition anorectal manometry and Pelvic Floor Ultrasonography

Healthy volunteer group

Women without any defecation disorders

Device: Impedance Planimetry, High-definition anorectal manometry and Pelvic Floor Ultrasonography

Interventions

Impedance Planimetry, High-definition anorectal manometry and Pelvic Floor Ultrasonography DEVICE

Global morpho-functional assessment of the anal sphincter complex using Impedance Planimetry, High-definition anorectal manometry and Pelvic Floor Ultrasonography

Anal incontinence group; Healthy volunteer group; Obstructive defecation group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women presenting symptoms of posterior compartment pelvic floor dysfunction (such as anal incontinence or obstructive defecation) referred for anorectal manometry evaluation.

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Hospital Clínic of Barcelona

Barcelona, Barcelona, 08036, Spain

Location

Related Publications (5)

• 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.

  PMID: 27657739 BACKGROUND

• 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.

  PMID: 30637863 BACKGROUND

• 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.

  PMID: 26046765 BACKGROUND

• 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.

  PMID: 32157322 BACKGROUND

• 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.

  PMID: 32408091 BACKGROUND

MeSH Terms

Conditions

Encopresis

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Neurogastroenterology and Motility section, Gastroenterology department

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: July 29, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)