Lower Urinary Tract Symptoms in Systemic Sclerosis

Sponsor

University Hospital, Geneva (Other)

Overall Status

Unknown status

CT.gov ID

NCT01971294

Collaborator

University Hospital, Paris (Other), Azienda Ospedaliera di Padova (Other), Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Other)

480

Enrollment

Locations

Duration (Months)

120

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Symptoms Systemic Sclerosis

Study Design

Study Type:

Observational

Anticipated Enrollment :

480 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Lower Urinary Tract Symptoms in Patients Suffering From Systemic Sclerosis: a Multi-centric Longitudinal Study

Study Start Date :

Oct 1, 2013

Anticipated Primary Completion Date :

Oct 1, 2015

Anticipated Study Completion Date :

Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Systemic sclerosis Adult suffering from systemic sclerosis included in the EUSTAR network of Brescia (I), Geneva (CH), Padova (I) and Paris (F).

Outcome Measures

Primary Outcome Measures

Prevalence/incidence of urinary symptoms in scleroderma [Inclusion and every year for 2 years]

Secondary Outcome Measures

Quality of life [At inclusion and after 2 years]
Mortality [During two years]
Urinary tract infection [During two years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Hôpital Cochin	Paris	France	75014
2	Azienda Ospedaliera Spedali Civili di Brescia	Brescia	Italy	25124
3	Azienda Ospedaliera di Padova	Padova	Italy	35121
4	Universtiy Hospital, Geneva	Geneva	Switzerland	1205

Sponsors and Collaborators

University Hospital, Geneva
University Hospital, Paris
Azienda Ospedaliera di Padova
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Investigators

Study Director: Carlo Chizzolini, Pr, University Hospital, Geneva
Study Chair: Yannick Allanor, Pr, Département de médecine interne, Hôpital Cochin, Paris
Study Chair: Franco Cozzi, MD, Department of Rheumatology, Azienda Ospedaliera di Padova, Padova (I)
Study Chair: Paolo Airo, MD, Department of Rheumatology and Clinical Immunology, Azienda Ospedaliera Spedali Civili di Brescia, Brescia (I)
Study Chair: Franco Franceschini, MD, Department of Rheumatology and Clinical Immunology, Azienda Ospedaliera Spedali Civili di Brescia, Brescia (I)