Lower Urinary Tract Symptoms in Systemic Sclerosis

NCT ID: NCT01971294

Last Updated: 2023-05-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 334 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2022-10-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Systemic sclerosis

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

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Paris

OTHER

Sponsor Role: collaborator

Azienda Ospedaliera di Padova

OTHER

Sponsor Role: collaborator

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

OTHER

Sponsor Role: collaborator

University Hospital, Geneva

OTHER

Sponsor Role: lead

Responsible Party

Gregor John

Gregor John

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carlo Chizzolini, Pr

Role: STUDY_DIRECTOR

University Hospital, Geneva

Yannick Allanor, Pr

Role: STUDY_CHAIR

Département de médecine interne, Hôpital Cochin, Paris

Franco Cozzi, MD

Role: STUDY_CHAIR

Department of Rheumatology, Azienda Ospedaliera di Padova, Padova (I)

Paolo Airo, MD

Role: STUDY_CHAIR

Department of Rheumatology and Clinical Immunology, Azienda Ospedaliera Spedali Civili di Brescia, Brescia (I)

Franco Franceschini, MD

Role: STUDY_CHAIR

Department of Rheumatology and Clinical Immunology, Azienda Ospedaliera Spedali Civili di Brescia, Brescia (I)

Locations

Hôpital Cochin

Paris, , France

Azienda Ospedaliera Spedali Civili di Brescia

Brescia, , Italy

Azienda Ospedaliera di Padova

Padua, , Italy

Universtiy Hospital, Geneva

Geneva, , Switzerland

Countries

France; Italy; Switzerland

References

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.

Reference Type: DERIVED

PMID: 29073343 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28977630 (View on PubMed)

Other Identifiers

CER 12-291

Identifier Type: -

Identifier Source: org_study_id