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

Hospital Clinic of Barcelona

Status

Active, not recruiting

Conditions

Obstructive Defecation

Anal Incontinence

Treatments

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

Study type

Observational

Funder types

Other

Identifiers

NCT06525207

HCB/2024/0523

Details and patient eligibility

About

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.

Enrollment

75 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.