Active — Not RecruitingNot Applicable

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

Spain75 participantsStarted 2024-09-01

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

Timeframe: Baseline

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

Timeframe: Baseline

Trial details

NCT IDNCT06525207

SponsorHospital Clinic of Barcelona

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-09-01

View on ClinicalTrials.gov More Anal Incontinence trials

Plain-language summary

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: Baseline

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

Timeframe: Baseline