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

Recurrent Cystitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04962971
• Other study ID #: C1635
• Status: Completed
• Start date: September 1, 2020
• Est. completion date: February 1, 2022

Study information

• Verified date: July 2021
• Source: CEN Biotech
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: February 1, 2022
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cystitis
• Recurrent Cystitis

Intervention

Dietary Supplement:
• X
exocyan
• Y
exocyan
• Z
exocyan

Locations

Country	Name	City	State
France	CEN Nutriment	Dijon	Burgundy

Sponsors (3)

Lead Sponsor	Collaborator
CEN Biotech	CEN Nutriment, Nexira

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cystitis symptomatic episodes occurence	Number of cystitis symptomatic episodes self-reported	Week 0 to Week 24
Primary	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
Primary	Change of the Urinary comfort	Visual Analogic score	on weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Secondary	Intensity of urinary disconfort	Global ACCS score	Every day during each urinary symptoms episod (Week 0 to Week 24)
Secondary	Patient Global Impression of Improvement	PGI-I scale related to Urinary discomfort	Week 4,Week 12,Week 24
Secondary	Evolution of the impact of urinary discomfort on psychosocial life	Likert 5 points scales	Week 0,Week 4,Week 12,Week 24
Secondary	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
Secondary	Satisfaction of the supplementation	Likert 5 points scales	Week 4,Week 12,Week 24
Secondary	Tolerance of the supplementation	Adverse events assessment	Week 4,Week 12,Week 24
Secondary	Observance of the supplementation	Total products minus remaining products	on Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24