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

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

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.

Study Overview

• Status: Completed
• Conditions: Recurrent Cystitis
• Intervention / Treatment: Dietary supplement: X; Dietary supplement: Y; Dietary supplement: Z

• Study Type: Observational
• Enrollment (Actual): 216

Contacts and Locations

Study Locations

• France
  • Burgundy
    • Dijon, Burgundy, France, 21000
      • CEN Nutriment

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cranberry extract X; 373 mg per Day	Dietary supplement: X; exocyan
Cranberry extract Y; 404 mg per Day	Dietary supplement: Y; exocyan
Cranberry extract Z; 2090 mg per Day	Dietary supplement: Z; exocyan

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cystitis symptomatic episodes occurence	Number of cystitis symptomatic episodes self-reported	Week 0 to Week 24

Collaborators and Investigators

• Sponsor: CEN Biotech
• Collaborators: Nexira; CEN Nutriment
• Investigators: Study Director: Christine JUHEL, CEN Nutriment

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): October 1, 2021
• Study Completion (Actual): February 1, 2022

Study Registration Dates

• First Submitted: June 17, 2021
• First Submitted That Met QC Criteria: July 5, 2021
• First Posted (Actual): July 15, 2021

Study Record Updates

• Last Update Posted (Actual): April 18, 2022
• Last Update Submitted That Met QC Criteria: April 11, 2022
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Cystitis
• Other Study ID Numbers: C1635

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No