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

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 Overview

• Status: Active, not recruiting
• Conditions: Anal Incontinence; Obstructive Defecation
• Intervention / Treatment: Device: Impedance Planimetry, High-definition anorectal manometry and Pelvic Floor Ultrasonography

• Study Type: Observational
• Enrollment (Estimated): 75

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic of Barcelona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Anal incontinence group; Women with anal incontinence and no symptoms of constipation	Device: 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	Device: 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	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	Baseline

Collaborators and Investigators

• Sponsor: Hospital Clinic of Barcelona

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: July 17, 2024
• First Submitted That Met QC Criteria: July 24, 2024
• First Posted (Actual): July 29, 2024

Study Record Updates

• Last Update Posted (Estimated): October 9, 2024
• Last Update Submitted That Met QC Criteria: October 5, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Impedance Planimetry; High Definition Anorectal Manometry
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Fecal Incontinence
• Other Study ID Numbers: HCB/2024/0523

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes