Recurrent Cystitis
Conditions
Brief summary
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.
Interventions
Sponsors
Nexira
CEN Nutriment
CEN Biotech
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* having had at least 3 symptomatic episodes of cystitis (including 1 urinary tract infection confirmed by a doctor) during the last 12 months * whose episode had a significant impact on quality of life / urinary discomfort (ACSS Dimension QoL ≥ 2) * had a smartphone compatible with Nurstrial smartphone application (e-CRF)
Exclusion criteria
* to be a pregnant or breastfeeding woman or planning to be pregnant within 6 months, * currently taking any other supplementation for urinary comfort or having taken any other cranberry-based food supplement in the past 3 months, * to be under antibiotic treatment or during the last 7 days preceding inclusion, * have urinary discomfort with a severe impact on quality of life (ACSS QoL\> 7) during the last 24 hours prior to inclusion, * have an allergy known to plants of the cranberry family or to one of the components of the products.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of the Urinary comfort | on weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 | Visual Analogic score |
| Change of the Quality of life related to urinary discomfort | at weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 | ACCS Quality of life score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Global Impression of Improvement | Week 4,Week 12,Week 24 | PGI-I scale related to Urinary discomfort |
| Evolution of the impact of urinary discomfort on psychosocial life | Week 0,Week 4,Week 12,Week 24 | Likert 5 points scales |
| Duration without antibiotic treatment | on Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 | Collection of the intake and the duration of the antibiotic treatment, if applicable |
| Tolerance of the supplementation | Week 4,Week 12,Week 24 | Adverse events assessment |
| Observance of the supplementation | on Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 | Total products minus remaining products |
| Satisfaction of the supplementation | Week 4,Week 12,Week 24 | Likert 5 points scales |
| Intensity of urinary disconfort | Every day during each urinary symptoms episod (Week 0 to Week 24) | Global ACCS score |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cystitis symptomatic episodes occurence | Week 0 to Week 24 | Number of cystitis symptomatic episodes self-reported |
Countries
France
Outcome results
None listed