Status:
ACTIVE_NOT_RECRUITING
New Diagnostic Tools in the Evaluation of the Posterior Compartment of the Women Pelvic Floor
Lead Sponsor:
Hospital Clinic of Barcelona
Conditions:
Anal Incontinence
Obstructive Defecation
Eligibility:
FEMALE
18+ years
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT06525207
Start Date
September 1 2024
End Date
December 1 2026
Last Update
October 9 2024
Active Locations (1)
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1
Hospital Clínic of Barcelona
Barcelona, Barcelona, Spain, 08036