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| Name | Class |
|---|---|
| Nexira | INDUSTRY |
| CEN Nutriment | UNKNOWN |
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Urinary discomfort includes a set of signs such as an urgent need to urinate, high frequency of urination per day, discomfort / difficulty or burning sensation when urinating, smelly urine. This urinary discomfort represents in women 2 to 5% of the reasons for consultation (Berg, 1991) and can have various etiologies but the bacterial origin is the most frequent. Cranberries are traditionally used for urinary comfort and the prevention of urinary disorders with bacterial origin.
The study objective is to collect in real life efficacy and tolerance data from the consumption of 3 cranberry extracts in order to highlight the qualitative and quantitative characteristics of these extracts which are directly involved in the improvement of urinary discomfort or situation of recurrent cystitis symptomatic episodes in women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cranberry extract X | 373 mg per Day |
| |
| Cranberry extract Y | 404 mg per Day |
| |
| Cranberry extract Z | 2090 mg per Day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| X | Dietary Supplement | exocyan |
| |
| Y |
| Measure | Description | Time Frame |
|---|---|---|
| Change of the Quality of life related to urinary discomfort | ACCS Quality of life score | at weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 |
| Change of the Urinary comfort | Visual Analogic score | on weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Intensity of urinary disconfort | Global ACCS score | Every day during each urinary symptoms episod (Week 0 to Week 24) |
| Patient Global Impression of Improvement | PGI-I scale related to Urinary discomfort |
| Measure | Description | Time Frame |
|---|---|---|
| Cystitis symptomatic episodes occurence | Number of cystitis symptomatic episodes self-reported | Week 0 to Week 24 |
Inclusion Criteria:
Exclusion Criteria:
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The first 216 women of the CEN Nutriment (Clinical Investigation Center) volunteer panel corresponding to the selection criteria and wishing to participate in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Christine JUHEL | CEN Nutriment | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CEN Nutriment | Dijon | Burgundy | 21000 | France |
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| ID | Term |
|---|---|
| D003556 | Cystitis |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Dietary Supplement |
exocyan |
|
| Z | Dietary Supplement | exocyan |
|
| Week 4,Week 12,Week 24 |
| Evolution of the impact of urinary discomfort on psychosocial life | Likert 5 points scales | Week 0,Week 4,Week 12,Week 24 |
| Duration without antibiotic treatment | Collection of the intake and the duration of the antibiotic treatment, if applicable | on Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 |
| Satisfaction of the supplementation | Likert 5 points scales | Week 4,Week 12,Week 24 |
| Tolerance of the supplementation | Adverse events assessment | Week 4,Week 12,Week 24 |
| Observance of the supplementation | Total products minus remaining products | on Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |