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Fecal Incontinence and Rectal Static Disorder

Evolution of Fecal Incontinence in Patients With Rectal Static Disorder

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04566640
Acronym
NATUROSTATIQ
Enrollment
85
Registered
2020-09-28
Start date
2021-05-15
Completion date
2022-08-17
Last updated
2026-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fecal Continence Disorders, Posterior Pelvic Static Disorders

Keywords

Fecal incontinence, pelvic static disorders

Brief summary

This study evaluate the rate of occurrence of fecal incontinence in patients who had surgery for posterior pelvic static disorder versus those with medical management. The aim is also to assess the natural history of constipation symptoms and quality of life in patients with posterior pelvic static disorder.

Detailed description

Data of all patients with posterior pelvic static disorder are collected prospectively and consecutively in the Fondamentum database since 2005, secured and hosted by the Rennes University Hospital. The data from initial functional assessment, carried out as part of routine care between 2005 and 2019, include a clinical examination of pelvic static disorders, anorectal manometry, defecography, collection of symptoms by questioning and by a systematic questionnaire completed by the patient during the routine care consultation. Patients identified from this database and meeting the selection criteria will receive an information letter along with a questionnaire and a stamped envelope for returning the questionnaire. The self-questionnaires will focus on collecting symptoms related to static disorders (incontinence, constipation, quality of life). Regarding the management of pelvic static disorder, we will detail whether it was operated or not, and what were the proposed medical care. Upon receipt of the questionnaire, the new data will be entered into the research-specific database and will complete the clinical data resulting from the extraction of the care base The self-administered questionnaire sent to patients includes validated constipation (score of kess) and fecal incontinence (Cleveland) questionnaires, and quality of life questions from the validated SF36 questionnaire. It also includes a visual scale ranging from -5 to +5.

Interventions

None listed

Sponsors

Rennes University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patient over 18 years of age * Having a disorder of posterior pelvic statics * Diagnosed during the period 2005 - 2019 * Having a functional assessment in proctology between 2005 and 2019 in the proctology department of the Rennes University Hospital Center (CHU) * This complete functional assessment was carried out in consultation with proctology, as part of routine care, and included : * Data from the interrogation * Reported symptoms: incontinence, constipation and quality of life (collected through questioning and through a questionnaire systematically completed by the patient during the routine care consultation), * A clinical examination * Anorectal manometry * A defecography * no one who does not object to participation in the research

Exclusion criteria

* persons of full age subject to legal protection (safeguard of justice, guardianship, trusteeship), persons deprived of liberty

Design outcomes

Primary

MeasureTime frameDescription
Fecal incontinence defined by a Cleveland score > 56 weeksThe objective of the study is to compare the rate of occurrence of fecal incontinence in patients who have had surgery for a disorder of posterior pelvic statics versus those with medical management.

Secondary

MeasureTime frameDescription
natural history of constipation symptoms in patients with posterior pelvic static disorders6 weeksEvaluation of Constipation Symptoms (Kess Score),
quality of life in patients with posterior pelvic static disorders6 weeksQuality of Life Score (Score SF36)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 13, 2026