Lower Urinary Tract Symptoms in Systemic Sclerosis
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| ClinicalTrials.gov Identifier: NCT01971294 |
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Recruitment Status : Unknown
Verified October 2013 by Gregor John, University Hospital, Geneva.
Recruitment status was: Enrolling by invitation
First Posted : October 29, 2013
Last Update Posted : October 29, 2013
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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.
| Condition or disease |
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| Urinary Symptoms Systemic Sclerosis |
| Study Type : | Observational |
| Estimated Enrollment : | 480 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Lower Urinary Tract Symptoms in Patients Suffering From Systemic Sclerosis: a Multi-centric Longitudinal Study |
| Study Start Date : | October 2013 |
| Estimated Primary Completion Date : | October 2015 |
| Estimated Study Completion Date : | October 2015 |
| Group/Cohort |
|---|
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Systemic sclerosis
Adult suffering from systemic sclerosis included in the EUSTAR network of Brescia (I), Geneva (CH), Padova (I) and Paris (F).
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- Prevalence/incidence of urinary symptoms in scleroderma [ Time Frame: Inclusion and every year for 2 years ]
- Quality of life [ Time Frame: At inclusion and after 2 years ]
- Mortality [ Time Frame: During two years ]
- Urinary tract infection [ Time Frame: During two years ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01971294
| France | |
| Hôpital Cochin | |
| Paris, France, 75014 | |
| Italy | |
| Azienda Ospedaliera Spedali Civili di Brescia | |
| Brescia, Italy, 25124 | |
| Azienda Ospedaliera di Padova | |
| Padova, Italy, 35121 | |
| Switzerland | |
| Universtiy Hospital, Geneva | |
| Geneva, Switzerland, 1205 | |
| Study Director: | Carlo Chizzolini, Pr | University Hospital, Geneva | |
| Study Chair: | Yannick Allanor, Pr | Département de médecine interne, Hôpital Cochin, Paris | |
| Study Chair: | Franco Cozzi, MD | Department of Rheumatology, Azienda Ospedaliera di Padova, Padova (I) | |
| Study Chair: | Paolo Airo, MD | Department of Rheumatology and Clinical Immunology, Azienda Ospedaliera Spedali Civili di Brescia, Brescia (I) | |
| Study Chair: | Franco Franceschini, MD | Department of Rheumatology and Clinical Immunology, Azienda Ospedaliera Spedali Civili di Brescia, Brescia (I) |
| Responsible Party: | Gregor John, University Hospital, Geneva |
| ClinicalTrials.gov Identifier: | NCT01971294 |
| Other Study ID Numbers: |
CER 12-291 |
| First Posted: | October 29, 2013 Key Record Dates |
| Last Update Posted: | October 29, 2013 |
| Last Verified: | October 2013 |
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Urinary symptoms Systemic sclerosis Severity index |
Urinary tract infection mortality Quality of life |
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Scleroderma, Systemic Scleroderma, Diffuse Sclerosis Lower Urinary Tract Symptoms |
Pathologic Processes Connective Tissue Diseases Skin Diseases Urological Manifestations |