Lower Urinary Tract Symptoms in Systemic Sclerosis

NCT01971294 | Completed

• 1 other identifier: CER 12-291
• Study Type: observational
• Target: 334
• Locations: 3 countries
• Sites: 4

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.

Conditions

Urinary Symptoms; Systemic Sclerosis

Keywords

Urinary symptoms; Systemic sclerosis; Severity index; Urinary tract infection; mortality; Quality of life

Outcome Measures

Primary Outcomes (1)

• Prevalence/incidence of urinary symptoms in scleroderma

  Inclusion and every year for 2 years

Secondary Outcomes (4)

• Short Form 36 Health Survey (SF-36)

  At inclusion and after 2 years

• Mortality

  During two years

• Urinary tract infection

  During two years

• Incontinence Quality of Life (IQol)

  At inclusion and after 2 years

Study Arms (1)

Systemic sclerosis

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (4)

Hôpital Cochin

Paris, 75014, France

Location

Azienda Ospedaliera Spedali Civili di Brescia

Brescia, 25124, Italy

Location

Azienda Ospedaliera di Padova

Padua, 35121, Italy

Location

Universtiy Hospital, Geneva

Geneva, 1205, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 29073343 DERIVED

• 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.

  PMID: 28977630 DERIVED

MeSH Terms

Conditions

Scleroderma, Systemic; Urinary Tract Infections

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Carlo Chizzolini, Pr

  University Hospital, Geneva

  STUDY DIRECTOR

• 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)

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gregor John

Study Record Dates

• First Submitted: October 23, 2013
• First Posted: October 29, 2013
• Study Start: October 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2022
• Last Updated: May 16, 2023

Record last verified: 2023-05

Locations

CH (1); FR (1); IT (2)