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OpenTrials
Completed

NCT Number: NCT01971294

Lower Urinary Tract Symptoms in Systemic Sclerosis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Cochin, Paris, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Prevalence/incidence of urinary symptoms in scleroderma

    Time frame: Inclusion and every year for 2 years

Secondary outcomes

  1. Short Form 36 Health Survey (SF-36)

    Time frame: At inclusion and after 2 years

    Quality of life (lower, better)

  2. Mortality

    Time frame: During two years

  3. Urinary tract infection

    Time frame: During two years

  4. Incontinence Quality of Life (IQol)

    Time frame: At inclusion and after 2 years

    Quality of life (0-100; higher, better), specific for urinary incontinence

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Collaborators

  • Azienda Ospedaliera di Padova
  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
  • University Hospital, Paris

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2022
First posted
Oct 29, 2013
Registry last updated
May 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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