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

N/AActive Not RecruitingNCT06525207

Hospital Clinic of Barcelona75 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Anal Incontinence Obstructive Defecation

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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)

Time frame: 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)

Time frame: Baseline

Secondary Outcomes

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.

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)

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.

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)

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.

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)

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.

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)

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.

Time frame: Baseline

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes