Lower Urinary Tract Symptoms in Systemic Sclerosis

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
University Hospital, Paris
Azienda Ospedaliera di Padova
Azienda Ospedaliera Spedali Civili di Brescia
Information provided by (Responsible Party):
Gregor John, University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT01971294
First received: October 23, 2013
Last updated: NA
Last verified: October 2013
History: No changes posted

October 23, 2013
October 23, 2013
October 2013
October 2015   (final data collection date for primary outcome measure)
Prevalence/incidence of urinary symptoms in scleroderma [ Time Frame: Inclusion and every year for 2 years ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Quality of life [ Time Frame: At inclusion and after 2 years ] [ Designated as safety issue: No ]
  • Mortality [ Time Frame: During two years ] [ Designated as safety issue: No ]
  • Urinary tract infection [ Time Frame: During two years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Lower Urinary Tract Symptoms in Systemic Sclerosis
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.

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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Systemic sclerosis suffering patients in Brescia (I), Geneva (CH), Padova (I) and Paris (F)

  • Urinary Symptoms
  • Systemic Sclerosis
Not Provided
Systemic sclerosis
Adult suffering from systemic sclerosis included in the EUSTAR network of Brescia (I), Geneva (CH), Padova (I) and Paris (F).
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
480
October 2015
October 2015   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France,   Italy,   Switzerland
 
NCT01971294
CER 12-291
No
Gregor John, University Hospital, Geneva
University Hospital, Geneva
  • University Hospital, Paris
  • Azienda Ospedaliera di Padova
  • Azienda Ospedaliera Spedali Civili di Brescia
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)
University Hospital, Geneva
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP