Lower Urinary Tract Symptoms in Systemic Sclerosis

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01971294
Study type	Observational
Source	University Hospital, Geneva
Contact
Status	Completed
Phase
Start date	October 2013
Completion date	October 2022

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.