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OpenTrials
Completed

NCT Number: NCT04962971

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

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.

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Key information

Conditions

Recurrent Cystitis Cystitis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urinary Bladder Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

CEN Nutriment

Dijon, Burgundy, 21000, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

X

Dietary Supplement

exocyan

Y

Dietary Supplement

exocyan

Z

Dietary Supplement

exocyan

Primary outcomes

  1. Change of the Quality of life related to urinary discomfort

    Time frame: at weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24

    ACCS Quality of life score

  2. Change of the Urinary comfort

    Time frame: on weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24

    Visual Analogic score

Secondary outcomes

  1. Intensity of urinary disconfort

    Time frame: Every day during each urinary symptoms episod (Week 0 to Week 24)

    Global ACCS score

  2. Patient Global Impression of Improvement

    Time frame: Week 4,Week 12,Week 24

    PGI-I scale related to Urinary discomfort

  3. Evolution of the impact of urinary discomfort on psychosocial life

    Time frame: Week 0,Week 4,Week 12,Week 24

    Likert 5 points scales

  4. Duration without antibiotic treatment

    Time frame: on Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24

    Collection of the intake and the duration of the antibiotic treatment, if applicable

  5. Satisfaction of the supplementation

    Time frame: Week 4,Week 12,Week 24

    Likert 5 points scales

  6. Tolerance of the supplementation

    Time frame: Week 4,Week 12,Week 24

    Adverse events assessment

  7. Observance of the supplementation

    Time frame: on Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24

    Total products minus remaining products

Other outcomes

  1. Cystitis symptomatic episodes occurence

    Time frame: Week 0 to Week 24

    Number of cystitis symptomatic episodes self-reported

Sponsors and collaborators

Lead sponsor

CEN Biotech

Industry

Collaborators

  • CEN Nutriment
  • Nexira

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Jul 15, 2021
Registry last updated
Apr 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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