Comparative Observational Study Evaluating the Urinary Comfort Related to Cystitis Symptoms Episodes and the Satisfaction of Women Following the Consumption of 3 Cranberry Extracts
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 216
- 试验地点
- 1
- 主要终点
- Change of the Urinary comfort
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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.
结局指标
主要结局
Change of the Urinary comfort
时间窗: 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
时间窗: at weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
ACCS Quality of life score
次要结局
- Intensity of urinary disconfort(Every day during each urinary symptoms episod (Week 0 to Week 24))
- Patient Global Impression of Improvement(Week 4,Week 12,Week 24)
- Duration without antibiotic treatment(on Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24)
- Observance of the supplementation(on Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24)
- Tolerance of the supplementation(Week 4,Week 12,Week 24)
- Evolution of the impact of urinary discomfort on psychosocial life(Week 0,Week 4,Week 12,Week 24)
- Satisfaction of the supplementation(Week 4,Week 12,Week 24)