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Lower Urinary Tract Symptoms in Systemic Sclerosis

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01971294
Enrollment
334
Registered
2013-10-29
Start date
2013-10-31
Completion date
2022-10-31
Last updated
2023-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Sclerosis, Urinary Symptoms

Keywords

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

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.

Interventions

None listed

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Prevalence/incidence of urinary symptoms in sclerodermaInclusion and every year for 2 years

Secondary

MeasureTime frameDescription
Short Form 36 Health Survey (SF-36)At inclusion and after 2 yearsQuality of life (lower, better)
MortalityDuring two years
Urinary tract infectionDuring two years
Incontinence Quality of Life (IQol)At inclusion and after 2 yearsQuality of life (0-100; higher, better), specific for urinary incontinence

Countries

France, Italy, Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026