Recurrent CystitisNCT04962971
Comparative Effect of 3 Different Cranberry Extracts on Cystitis Related Urinary Comfort in Women
An observational study of Recurrent Cystitis, run by CEN Biotech at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Recurrent Cystitis
- What is being tested?
- X, Y and Z
- How many people
- 216 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2020to 1 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Recurrent Cystitis
- Being tested
- X, Y, Z
- Medical subject headings
- Cystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XDietary supplement
exocyan
YDietary supplement
exocyan
ZDietary supplement
exocyan
| Study group | Role | What they receive |
|---|---|---|
| Cranberry extract X | 373 mg per Day Receives: Dietary Supplement: X | |
| Cranberry extract Y | 404 mg per Day Receives: Dietary Supplement: Y | |
| Cranberry extract Z | 2090 mg per Day Receives: Dietary Supplement: Z |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the Quality of life related to urinary discomfort
ACCS Quality of life score
Measured: at weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Change of the Urinary comfort
Visual Analogic score
Measured: on weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Secondary outcomes (7)
Intensity of urinary disconfort
Global ACCS score
Measured: Every day during each urinary symptoms episod (Week 0 to Week 24)
Patient Global Impression of Improvement
PGI-I scale related to Urinary discomfort
Measured: Week 4,Week 12,Week 24
Evolution of the impact of urinary discomfort on psychosocial life
Likert 5 points scales
Measured: 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
Measured: on Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Satisfaction of the supplementation
Likert 5 points scales
Measured: Week 4,Week 12,Week 24
Tolerance of the supplementation
Adverse events assessment
Measured: Week 4,Week 12,Week 24
Observance of the supplementation
Total products minus remaining products
Measured: on Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start1 Sep 2020
- Primary completion1 Oct 2021
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Recurrent CystitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- CEN Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nexira, CEN Nutriment
- Responsible party
- Sponsor
- Investigators
- Christine JUHEL, Study director, CEN Nutriment
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04962971
- Sponsor's protocol ID
- C1635
- Status last verified
- Jul 2021
- First submitted
- 17 Jun 2021
- Last updated
- 18 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Guillemet D, Juhel C, Rigaudier F, Herpin F, Meudec E. Comparative Evaluation of Three Cranberry Formulations in Women with Recurrent Urinary Tract Infections: An Observational Study. Res Rep Urol. 2026 Sep 7;18:613306. doi: 10.2147/RRU.S613306. eCollection 2026.
PubMed 42730009
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04962971
- Acronym / sponsor ID
- C1635
- Conditions
- Recurrent Cystitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- CEN BiotechIndustry (pharma, biotech, devices)
- Collaborators
- Nexira, CEN Nutriment
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 15 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cranberry extract X | – | Dietary Supplement: X373 mg per Day |
| Cranberry extract Y | – | Dietary Supplement: Y404 mg per Day |
| Cranberry extract Z | – | Dietary Supplement: Z2090 mg per Day |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xexocyan | Dietary supplement | Cranberry extract X |
| Yexocyan | Dietary supplement | Cranberry extract Y |
| Zexocyan | Dietary supplement | Cranberry extract Z |
Primary outcome
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
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
7 secondary outcomes
Intensity of urinary disconfort
Time frame: Every day during each urinary symptoms episod (Week 0 to Week 24)
Patient Global Impression of Improvement
Time frame: Week 4,Week 12,Week 24
Evolution of the impact of urinary discomfort on psychosocial life
Time frame: Week 0,Week 4,Week 12,Week 24
Duration without antibiotic treatment
Time frame: on Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Satisfaction of the supplementation
Time frame: Week 4,Week 12,Week 24
Tolerance of the supplementation
Time frame: Week 4,Week 12,Week 24
Observance of the supplementation
Time frame: on Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2022.
- Derived from this study: PubMed 42730009Guillemet D, Juhel C, Rigaudier F, Herpin F, Meudec E. Comparative Evaluation of Three Cranberry Formulations in Women with Recurrent Urinary Tract Infections: An Observational Study. Res Rep Urol. 2026 Sep 7;18:613306. doi: 10.2147/RRU.S613306. eCollection 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine JUHEL study director
CEN Nutriment
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Recurrent Cystitis, run by CEN Biotech at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04962971, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2022.