Lower Urinary Tract Symptoms in Systemic Sclerosis

Completed

• Conditions: Systemic Sclerosis; Urinary Symptoms

• Registration Number: NCT01971294
• Lead Sponsor: University Hospital, Geneva

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-23
• Study First Submitted QC: 2013-10-23
• Study First Posted: 2013-10-29
• Primary Completion: 2015-10
• Study Completion: 2022-10
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-12
• Last Update Posted: 2023-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 334

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence/incidence of urinary symptoms in scleroderma	Inclusion and every year for 2 years

Secondary Outcome Measures

Name	Time	Method
Short Form 36 Health Survey (SF-36)	At inclusion and after 2 years	Quality of life (lower, better)
Incontinence Quality of Life (IQol)	At inclusion and after 2 years	Quality of life (0-100; higher, better), specific for urinary incontinence
Mortality	During two years
Urinary tract infection	During two years

Trial Locations

Locations (4)

Azienda Ospedaliera Spedali Civili di Brescia; 🇮🇹 Brescia, Italy

Universtiy Hospital, Geneva; 🇨🇭 Geneva, Switzerland

Hôpital Cochin; 🇫🇷 Paris, France

Azienda Ospedaliera di Padova; 🇮🇹 Padova, Italy