Fecal Continence DisordersNATUROSTATIQNCT04566640
Fecal Incontinence and Rectal Static Disorder
An observational study of Fecal Continence Disorders and Posterior Pelvic Static Disorders, run by Rennes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fecal Continence Disorders, Posterior Pelvic Static Disorders
- How many people
- 85 participants
- Where
- 1 siteFrance
- Study dates
- 15 May 2021to 17 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients having a posterior pelvic static disorder diagnosed and having benefited from a functional review in proctology between 2005 and 2019 in the proctology department of the University Hospital of Rennes
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- persons of full age subject to legal protection (safeguard of justice, guardianship, trusteeship), persons deprived of liberty
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evolution of Fecal Incontinence in Patients With Rectal Static Disorder
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.
Read the 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.
- Keywords
- Fecal incontinence, pelvic static disorders
- Medical subject headings
- Fecal Incontinence
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal incontinence defined by a Cleveland score > 5
The 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.
Measured: 6 weeks
Secondary outcomes (2)
natural history of constipation symptoms in patients with posterior pelvic static disorders
Evaluation of Constipation Symptoms (Kess Score),
Measured: 6 weeks
quality of life in patients with posterior pelvic static disorders
Quality of Life Score (Score SF36)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start15 May 2021
- Primary completion17 Aug 2022
- Study completion17 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fecal Continence DisordersStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04566640
- Sponsor's protocol ID
- 35RC20_3074_NATUROSTATIQ
- Acronym
- NATUROSTATIQ
- Status last verified
- Jun 2026
- First submitted
- 15 Sep 2020
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of Fecal Incontinence in Patients With Rectal Static Disorder
- ClinicalTrials.gov ID
- NCT04566640
- Acronym / sponsor ID
- NATUROSTATIQ / 35RC20_3074_NATUROSTATIQ
- Keywords
- Fecal incontinence, pelvic static disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 15 May 2021 (actual)
- Primary completion
- 17 Aug 2022 (actual)
- Study completion
- 17 Aug 2022 (actual)
- First posted
- 28 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients having a posterior pelvic static disorder diagnosed and having benefited from a functional review in proctology between 2005 and 2019 in the proctology department of the University Hospital of Rennes
Key inclusion criteria (11 listed)
- 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 :
Key exclusion criteria (1 listed)
- persons of full age subject to legal protection (safeguard of justice, guardianship, trusteeship), persons deprived of liberty
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fecal incontinence defined by a Cleveland score > 5
Time frame: 6 weeks
The 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.
2 secondary outcomes
natural history of constipation symptoms in patients with posterior pelvic static disorders
Time frame: 6 weeks
quality of life in patients with posterior pelvic static disorders
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fecal Continence Disorders and Posterior Pelvic Static Disorders, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fecal incontinence defined by a Cleveland score > 5 (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026; AzTrials last refreshed its copy on 2 Nov 2026.