NCT04962971

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
216

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2021

Completed
28 days until next milestone

First Posted

Study publicly available on registry

July 15, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

April 18, 2022

Status Verified

July 1, 2021

Enrollment Period

1.1 years

First QC Date

June 17, 2021

Last Update Submit

April 11, 2022

Conditions

Recurrent Cystitis

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (7)

  • 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

  • Evolution of the impact of urinary discomfort on psychosocial life

    Week 0,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

  • Satisfaction of the supplementation

    Week 4,Week 12,Week 24

  • +2 more secondary outcomes

Other Outcomes (1)

  • Cystitis symptomatic episodes occurence

    Week 0 to Week 24

Study Arms (3)

Cranberry extract X

373 mg per Day

Dietary Supplement: X

Cranberry extract Y

404 mg per Day

Dietary Supplement: Y

Cranberry extract Z

2090 mg per Day

Dietary Supplement: Z

Interventions

XDIETARY_SUPPLEMENT

exocyan

Cranberry extract X
YDIETARY_SUPPLEMENT

exocyan

Cranberry extract Y
ZDIETARY_SUPPLEMENT

exocyan

Cranberry extract Z

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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)

You may not qualify if:

  • 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,
  • have an allergy known to plants of the cranberry family or to one of the components of the products.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CEN Nutriment

Dijon, Burgundy, 21000, France

Location

MeSH Terms

Conditions

Cystitis

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Christine JUHEL

    CEN Nutriment

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2021

First Posted

July 15, 2021

Study Start

September 1, 2020

Primary Completion

October 1, 2021

Study Completion

February 1, 2022

Last Updated

April 18, 2022

Record last verified: 2021-07

Locations

FR(1)