Urinary SymptomsNCT01971294
Lower Urinary Tract Symptoms in Systemic Sclerosis
An observational study of Urinary Symptoms and Systemic Sclerosis, run by University Hospital, Geneva at 4 sites in 3 countries.
Trial summary
Urinary symptoms must be frequent in Scleroderma. In one hand, mobility limitation by joint stiffness and skin sclerosis, forced diuresis due to heart involvement (cardiomyopathy or pulmonary hypertension), diuretics use and corticoid-induced hyperglycaemia, as well as narcotic medication use, puts patients at higher… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Symptoms, Systemic Sclerosis
- How many people
- 334 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Oct 2013to Oct 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: Systemic sclerosis suffering patients in Brescia (I), Geneva (CH), Padova (I) and Paris (F)
Who may be able to join
- Adult suffering from systemic sclerosis included in network of Brescia (I), Geneva (CH), Padova (I) and Paris (F).
Who cannot join
- Those unable to understand the rules and implications of the study, end of life patients, the pregnant women and anuric patients
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Italy2 sites
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, 25124
Azienda Ospedaliera di Padova
Padova, 35121
About this study
Official title: Lower Urinary Tract Symptoms in Patients Suffering From Systemic Sclerosis: a Multi-centric Longitudinal Study
Urinary symptoms must be frequent in Scleroderma. In one hand, mobility limitation by joint stiffness and skin sclerosis, forced diuresis due to heart involvement (cardiomyopathy or pulmonary hypertension), diuretics use and corticoid-induced hyperglycaemia, as well as narcotic medication use, puts patients at higher risk of secondary bladder filling and voiding dysfunction. In another hand, few case report and small sample observational studies have identified a specific sclerosis of the urinary tract. Those two mechanisms must be more frequent in the diffuse cutaneous form of scleroderma (dcSSc) compare to the limited one (lcSSc). But prevalence or incidence is unknown.
Urinary symptoms are seldom reported by those suffering from them and are rarely part of a systemic evaluation. In a threatening disease, urinary symptoms assessment might seem to be of no priority. But LUTS have a real impact on many aspect of everyday living. Furthermore urinary tract involvement might predispose to urinary tract infection due to flow limitation and stagnation. Since it is an inner fibrosis it might be associated with a more aggressive form of disease conferring a greater loss of physical function, higher risk for hospital admission and death.
Read more
Thus, identifying urinary symptoms would permit to address specific rehabilitation or medication therapy, in order to minimize the consequences of the bothersome symptoms and identify those subjects at higher risk of urinary infection, aggressive disease/loss of function or death.
This study will also give basement to build an interventional study directed toward LUTS treatment in this population.
In this prospective cohort we would like to:
- Compare the prevalence of lower urinary tract symptoms (LUTS) in diffuse and limited forms of systemic sclerosis.
- Determine the prevalence (at inclusion) and incidence (in a two years period) of LUTS among patients suffering from systemic sclerosis.
- Evaluate the impact of LUTS symptoms on Quality of life.
- Compare the discrimination ability of Cochin-hand score and HAQ score to predict incontinence in this population.
- Evaluate the association between LUTS symptoms, hospital admission rate, urinary tract infection, mortality and loss of autonomy.
- Conditions
- Urinary Symptoms, Systemic Sclerosis
- Keywords
- Urinary symptoms, Systemic sclerosis, Severity index, Urinary tract infection, mortality, Quality of life
- Medical subject headings
- Scleroderma, Systemic, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Systemic sclerosis | Adult suffering from systemic sclerosis included in the EUSTAR network of Brescia (I), Geneva (CH), Padova (I) and Paris (F). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence/incidence of urinary symptoms in scleroderma
Measured: Inclusion and every year for 2 years
Secondary outcomes (4)
Short Form 36 Health Survey (SF-36)
Quality of life (lower, better)
Measured: At inclusion and after 2 years
Mortality
Measured: During two years
Urinary tract infection
Measured: During two years
Incontinence Quality of Life (IQol)
Quality of life (0-100; higher, better), specific for urinary incontinence
Measured: At inclusion and after 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionOct 2015
- Study completionOct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Urinary SymptomsStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe 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
- 334 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Paris, Azienda Ospedaliera di Padova, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Responsible party
- Principal investigator, Gregor John, University Hospital, Geneva
- Investigators
- Carlo Chizzolini, Pr, Study director, University Hospital, GenevaYannick Allanor, Pr, Study chair, Département de médecine interne, Hôpital Cochin, ParisFranco Cozzi, MD, Study chair, Department of Rheumatology, Azienda Ospedaliera di Padova, Padova (I)Paolo Airo, MD, Study chair, Department of Rheumatology and Clinical Immunology, Azienda Ospedaliera Spedali Civili di Brescia, Brescia (I)Franco Franceschini, MD, Study chair, Department of Rheumatology and Clinical Immunology, Azienda Ospedaliera Spedali Civili di Brescia, Brescia (I)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01971294
- Sponsor's protocol ID
- CER 12-291
- Status last verified
- May 2023
- First submitted
- 23 Oct 2013
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
John G, Avouac J, Piantoni S, Polito P, Fredi M, Cozzi F, Airo P, Truchetet ME, Franceschini F, Allanore Y, Chizzolini C. Prevalence and Disease-Specific Risk Factors for Lower Urinary Tract Symptoms in Systemic Sclerosis: An International Multicenter Study. Arthritis Care Res (Hoboken). 2018 Aug;70(8):1218-1227. doi: 10.1002/acr.23454. Epub 2018 Jun 19.
PubMed 29073343John G, Allanore Y, Polito P, Piantoni S, Fredi M, Avouac J, Franceschini F, Truchetet ME, Cozzi F, Airo P, Chizzolini C. The limited cutaneous form of systemic sclerosis is associated with urinary incontinence: an international multicentre study. Rheumatology (Oxford). 2017 Nov 1;56(11):1874-1883. doi: 10.1093/rheumatology/kex230.
PubMed 28977630
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lower Urinary Tract Symptoms in Patients Suffering From Systemic Sclerosis: a Multi-centric Longitudinal Study
- ClinicalTrials.gov ID
- NCT01971294
- Acronym / sponsor ID
- CER 12-291
- Conditions
- Urinary Symptoms, Systemic Sclerosis
- Keywords
- Urinary symptoms, Systemic sclerosis, Severity index, Urinary tract infection, mortality, Quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 334 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Collaborators
- University Hospital, Paris, Azienda Ospedaliera di Padova, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Study start
- Oct 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2022 (actual)
- First posted
- 29 Oct 2013 (estimated)
- 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.
Urinary symptoms must be frequent in Scleroderma. In one hand, mobility limitation by joint stiffness and skin sclerosis, forced diuresis due to heart involvement (cardiomyopathy or pulmonary hypertension), diuretics use and corticoid-induced hyperglycaemia, as well as narcotic medication use, puts patients at higher risk of secondary bladder filling and voiding dysfunction. In another hand, few case report and small sample observational studies have identified a specific sclerosis of the urinary tract. Those two mechanisms must be more frequent in the diffuse cutaneous form of scleroderma (dcSSc) compare to the limited one (lcSSc). But prevalence or incidence is unknown.
Urinary symptoms are seldom reported by those suffering from them and are rarely part of a systemic evaluation. In a threatening disease, urinary symptoms assessment might seem to be of no priority. But LUTS have a real impact on many aspect of everyday living. Furthermore urinary tract involvement might predispose to urinary tract infection due to flow limitation and stagnation. Since it is an inner fibrosis it might be associated with a more aggressive form of disease conferring a greater loss of physical function, higher risk for hospital admission and death.
Thus, identifying urinary symptoms would permit to address specific rehabilitation or medication therapy, in order to minimize the consequences of the bothersome symptoms and identify those subjects at higher risk of urinary infection, aggressive disease/loss of function or death.
This study will also give basement to build an interventional study directed toward LUTS treatment in this population.
In this prospective cohort we would like to:
- Compare the prevalence of lower urinary tract symptoms (LUTS) in diffuse and limited forms of systemic sclerosis.
- Determine the prevalence (at inclusion) and incidence (in a two years period) of LUTS among patients suffering from systemic sclerosis.
- Evaluate the impact of LUTS symptoms on Quality of life.
- Compare the discrimination ability of Cochin-hand score and HAQ score to predict incontinence in this population.
- Evaluate the association between LUTS symptoms, hospital admission rate, urinary tract infection, mortality and loss of autonomy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Systemic sclerosis | – | –Adult suffering from systemic sclerosis included in the EUSTAR network of Brescia (I), Geneva (CH), Padova (I) and Paris (F). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Systemic sclerosis suffering patients in Brescia (I), Geneva (CH), Padova (I) and Paris (F)
Key inclusion criteria (1 listed)
- Adult suffering from systemic sclerosis included in network of Brescia (I), Geneva (CH), Padova (I) and Paris (F).
Key exclusion criteria (1 listed)
- Those unable to understand the rules and implications of the study, end of life patients, the pregnant women and anuric patients
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
Prevalence/incidence of urinary symptoms in scleroderma
Time frame: Inclusion and every year for 2 years
4 secondary outcomes
Short Form 36 Health Survey (SF-36)
Time frame: At inclusion and after 2 years
Mortality
Time frame: During two years
Urinary tract infection
Time frame: During two years
Incontinence Quality of Life (IQol)
Time frame: At inclusion and after 2 years
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 16 May 2023.
- Derived from this study: PubMed 29073343John G, Avouac J, Piantoni S, Polito P, Fredi M, Cozzi F, Airo P, Truchetet ME, Franceschini F, Allanore Y, Chizzolini C. Prevalence and Disease-Specific Risk Factors for Lower Urinary Tract Symptoms in Systemic Sclerosis: An International Multicenter Study. Arthritis Care Res (Hoboken). 2018 Aug;70(8):1218-1227. doi: 10.1002/acr.23454. Epub 2018 Jun 19.
- Derived from this study: PubMed 28977630John G, Allanore Y, Polito P, Piantoni S, Fredi M, Avouac J, Franceschini F, Truchetet ME, Cozzi F, Airo P, Chizzolini C. The limited cutaneous form of systemic sclerosis is associated with urinary incontinence: an international multicentre study. Rheumatology (Oxford). 2017 Nov 1;56(11):1874-1883. doi: 10.1093/rheumatology/kex230.
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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.
Carlo Chizzolini, Pr study director
University Hospital, Geneva
Yannick Allanor, Pr study chair
Département de médecine interne, Hôpital Cochin, Paris
Franco Cozzi, MD study chair
Department of Rheumatology, Azienda Ospedaliera di Padova, Padova (I)
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Symptoms and Systemic Sclerosis, run by University Hospital, Geneva at 4 sites in 3 countries.
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 1 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 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy, France, Switzerland. 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?
Prevalence/incidence of urinary symptoms in scleroderma (time frame: Inclusion and every year for 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01971294, which also lists 2 linked publications.
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 16 May 2023.