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
  Purpose

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
Urinary Symptoms
Systemic Sclerosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Lower Urinary Tract Symptoms in Patients Suffering From Systemic Sclerosis: a Multi-centric Longitudinal Study

Resource links provided by NLM:


Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • Prevalence/incidence of urinary symptoms in scleroderma [ Time Frame: Inclusion and every year for 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 480
Study Start Date: October 2013
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Systemic sclerosis
Adult suffering from systemic sclerosis included in the EUSTAR network of Brescia (I), Geneva (CH), Padova (I) and Paris (F).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01971294

Locations
France
Hôpital Cochin
Paris, France, 75014
Italy
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, Italy, 25124
Azienda Ospedaliera di Padova
Padova, Italy, 35121
Switzerland
Universtiy Hospital, Geneva
Geneva, Switzerland, 1205
Sponsors and Collaborators
University Hospital, Geneva
University Hospital, Paris
Azienda Ospedaliera di Padova
Azienda Ospedaliera 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)
  More Information

No publications provided

Responsible Party: Gregor John, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT01971294     History of Changes
Other Study ID Numbers: CER 12-291
Study First Received: October 23, 2013
Last Updated: October 23, 2013
Health Authority: Switzerland: Federal Office of Public Health

Keywords provided by University Hospital, Geneva:
Urinary symptoms
Systemic sclerosis
Severity index
Urinary tract infection
mortality
Quality of life

Additional relevant MeSH terms:
Scleroderma, Systemic
Scleroderma, Diffuse
Sclerosis
Lower Urinary Tract Symptoms
Connective Tissue Diseases
Skin Diseases
Pathologic Processes
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014