New Diagnostic Tools in the Evaluation of the Posterior Compartment of the Women Pelvic Floor
NCT Number: NCT06525207
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Anal Incontinence|Obstructive Defecation
Interventions: DEVICE: Impedance Planimetry, High-definition anorectal manometry and Pelvic Floor Ultrasonography
Sponsor: Hospital Clinic of Barcelona
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 75
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2026-12-01
Locations: Hospital Clínic of Barcelona, Barcelona, 08036, Spain

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.

Primary Outcome Measures: 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: 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