Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06525207

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Anal Incontinence Behavior Behavioral Symptoms Elimination Disorders Encopresis Mental Disorders Obstructive Defecation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Hospital Clínic of Barcelona

Barcelona, 08036, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Assess the diagnostic accuracy of the Impedance Planimetry system in patients with anal incontinence, obstructive defecation and healthy women.

    Time frame: Baseline

    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)

  2. Assess the diagnostic accuracy of the High-definition anorectal manometry in patients with anal incontinence, obstructive defecation and healthy women.

    Time frame: Baseline

    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)

Secondary outcomes

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

    Time frame: Baseline

    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.

  2. 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)

    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)

    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.

  3. 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)

    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)

    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.

  4. 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)

    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)

    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.

  5. 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)

    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)

    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.

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 29, 2024
Registry last updated
Oct 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.