Clinical trial NCT01971294: Lower Urinary Tract Symptoms in Systemic Sclerosis
Official title: Lower Urinary Tract Symptoms in Patients Suffering From Systemic Sclerosis: a Multi-centric Longitudinal Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Symptoms
Systemic Sclerosis
Keywords: Urinary symptoms
Systemic sclerosis
Severity index
Urinary tract infection
mortality
Quality of life
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
Collaborators: name: University Hospital, Paris
name: Azienda Ospedaliera di Padova
name: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
First posted: 2013-10-29
Enrollment: 334
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Systemic sclerosis suffering patients in Brescia (I), Geneva (CH), Padova (I) and Paris (F)

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

Adult suffering from systemic sclerosis included in network of Brescia (I), Geneva (CH), Padova (I) and Paris (F).

Exclusion Criteria:

Those unable to understand the rules and implications of the study, end of life patients, the pregnant women and anuric patients

Primary outcomes:
measure: Prevalence/incidence of urinary symptoms in scleroderma
timeFrame: Inclusion and every year for 2 years
Secondary outcomes:
measure: Short Form 36 Health Survey (SF-36)
timeFrame: At inclusion and after 2 years
measure: Mortality
timeFrame: During two years
measure: Urinary tract infection
timeFrame: During two years
measure: Incontinence Quality of Life (IQol)
timeFrame: At inclusion and after 2 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Cochin
city: Brescia
country: Italy
facility: Azienda Ospedaliera Spedali Civili di Brescia
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
city: Geneva
country: Switzerland
facility: Universtiy Hospital, Geneva
Study officials:
affiliation: University Hospital, Geneva
name: Carlo Chizzolini, Pr
role: STUDY_DIRECTOR
affiliation: Département de médecine interne, Hôpital Cochin, Paris
name: Yannick Allanor, Pr
role: STUDY_CHAIR
affiliation: Department of Rheumatology, Azienda Ospedaliera di Padova, Padova (I)
name: Franco Cozzi, MD
role: STUDY_CHAIR
affiliation: Department of Rheumatology and Clinical Immunology, Azienda Ospedaliera Spedali Civili di Brescia, Brescia (I)
name: Paolo Airo, MD
role: STUDY_CHAIR
affiliation: Department of Rheumatology and Clinical Immunology, Azienda Ospedaliera Spedali Civili di Brescia, Brescia (I)
name: Franco Franceschini, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: John 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.