Comparative Effect of 3 Different Cranberry Extracts on Cystitis Related Urinary Comfort in Women

Study Overview
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Brief Summary
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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.

Official Title
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Comparative Observational Study Evaluating the Urinary Comfort Related to Cystitis Symptoms Episodes and the Satisfaction of Women Following the Consumption of 3 Cranberry Extracts

Conditions
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Recurrent Cystitis

Intervention / Treatment
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* Dietary Supplement: X
* Dietary Supplement: Y
* Dietary Supplement: Z


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cranberry extract X<br>373 mg per Day | Dietary Supplement: X<br>* exocyan<br>|
| Cranberry extract Y<br>404 mg per Day | Dietary Supplement: Y<br>* exocyan<br>|
| Cranberry extract Z<br>2090 mg per Day | Dietary Supplement: Z<br>* exocyan<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |