Clinical trial NCT04962971: Comparative Effect of 3 Different Cranberry Extracts on Cystitis Related Urinary Comfort in Women
Official title: Comparative Observational Study Evaluating the Urinary Comfort Related to Cystitis Symptoms Episodes and the Satisfaction of Women Following the Consumption of 3 Cranberry Extracts
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Recurrent Cystitis
Lead sponsor: CEN Biotech
Sponsor class: INDUSTRY
Collaborators: name: Nexira
name: CEN Nutriment
First posted: 2021-07-15
Enrollment: 216
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change of the Quality of life related to urinary discomfort
timeFrame: at weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
measure: Change of the Urinary comfort
timeFrame: on weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Secondary outcomes:
measure: Intensity of urinary disconfort
timeFrame: Every day during each urinary symptoms episod (Week 0 to Week 24)
measure: Patient Global Impression of Improvement
timeFrame: Week 4,Week 12,Week 24
measure: Evolution of the impact of urinary discomfort on psychosocial life
timeFrame: Week 0,Week 4,Week 12,Week 24
measure: Duration without antibiotic treatment
timeFrame: on Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
measure: Satisfaction of the supplementation
timeFrame: Week 4,Week 12,Week 24
measure: Tolerance of the supplementation
timeFrame: Week 4,Week 12,Week 24
measure: Observance of the supplementation
timeFrame: on Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Other outcomes:
measure: Cystitis symptomatic episodes occurence
timeFrame: Week 0 to Week 24
Locations:
city: Dijon
country: France
facility: CEN Nutriment
state: Burgundy
Study officials:
affiliation: CEN Nutriment
name: Christine JUHEL
role: STUDY_DIRECTOR
References: