Lower Urinary Tract Symptoms in Systemic Sclerosis

Systemic Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01971294
• Other study ID #: CER 12-291
• Status: Completed
• Start date: October 2013
• Est. completion date: October 2022

Study information

• Verified date: May 2023
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 334
• Est. completion date: October 2022
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lower Urinary Tract Symptoms
• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis
• Urinary Symptoms

Locations

Country	Name	City	State
France	Hôpital Cochin	Paris
Italy	Azienda Ospedaliera Spedali Civili di Brescia	Brescia
Italy	Azienda Ospedaliera di Padova	Padova
Switzerland	Universtiy Hospital, Geneva	Geneva

Sponsors (4)

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

Countries where clinical trial is conducted

France,  Italy,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence/incidence of urinary symptoms in scleroderma		Inclusion and every year for 2 years
Secondary	Short Form 36 Health Survey (SF-36)	Quality of life (lower, better)	At inclusion and after 2 years
Secondary	Mortality		During two years
Secondary	Urinary tract infection		During two years
Secondary	Incontinence Quality of Life (IQol)	Quality of life (0-100; higher, better), specific for urinary incontinence	At inclusion and after 2 years