CystitisARIBONCT04272281
Use of a Share Decision Making Tool in the Care of Acute Cystitis Without Risk of Complication in Primary Care
A study testing medical shared decision and Standard medical care in people with Cystitis, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
the aim of this trial is to demonstrate that when caring women with symptoms of acute cystitis without any risk of complication, general practitioner may use share decision making tool to help patients better understand the stakes of taking antibiotics. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Cystitis
- What is being tested?
- medical shared decision and Standard medical care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 169 participants
- Where
- 1 siteFrance
- Study dates
- 22 Jul 2020to 17 Feb 2022
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- woman
- between 18 and 65 years
- symptom of acute cystitis without risk of complication
- affiliated to the French public welfare system
- with signed consent
Who cannot join
- anomaly of the urinary canal
- pregnancy
- more than 3 cystitis during the last year
- cancer, immunosuppression
- hemopathy, fever
- back-pain
Show all 9Show fewer
- severe renal failure
- refuse to give consent and previously participate to the study
- under guardianship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Utilisation d'un Outil de décision médicale partagée Dans la Prise en Charge Des Cystites Aigues Sans Risque de Complication en médecine générale : Comparaison de la Consommation d'Antibiotique Entre Deux Groupes randomisés en Cluster.
the aim of this trial is to demonstrate that when caring women with symptoms of acute cystitis without any risk of complication, general practitioner may use share decision making tool to help patients better understand the stakes of taking antibiotics.
Read the detailed description
Each year, more than 2.000.000 patients visit their general practitioners for a acute cystitis. The scientific literature shows that acute cystitis without risk of complication cause complications, such as pyelonephritis, in a very rare cases. However, French guidelines systematically request an antibiotic therapy as soon as the diagnostic is confirmed with the only goal to lowering symptomatology.
Recent studies show that some informed women would like not to take antibiotics and pain-killers could be as effective as antibiotics. Canadian studies assessing share decision making tools in patients with acute respiratory infection have shown that matching antibiotic treatment with the patient values lower such prescription without any impact on clinical outcomes .
Investigators aim to assess a similar strategy in patients with acute cystitis. This study will compare a group following French guidelines versus one using a share decision making tool to determine if, after being informed of the benefice and risk of this treatment, patient still want an antibiotic. Targeting instead of systematic prescription will reduce antibiotic consumption.
After diagnostic of acute cystitis to a woman between 18 and 65 years, investigators check if they filing all study criteria and ask for authorization to add them to the study. Then they'll act following their group instruction, and get information (antibiotic prescription or not, score to the Activity Impairment Assessment (AIA) scale, Score to satisfaction scale). Then patients will be followed by phone contact on day 5, day 14 and day 90 after inclusion to get information on antibiotic use, AIA and satisfaction scores and clinical outcomes, such urinary infection. Data on antibiotics delivery by pharmacy will be obtained through National assurance database.
- Conditions
- Cystitis
- Being tested
- medical shared decision, Standard medical care
- Keywords
- primary health care, share decision making, antibiotics, daily activities
- Medical subject headings
- Cystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medical shared decisionProcedure or surgery
The experimental group will use the share decision making tool during consultation to adapt antibiotherapy
Standard medical careProcedure or surgery
control group will act as usual in their practice.
| Study group | Role | What they receive |
|---|---|---|
| Share making tool decision | Experimental | Patient recruited from general practitioner in this group will use a share making tool decision to adapt antibiotherapy Receives: Procedure: medical shared decision |
| Standard recommandation | Active comparator | Patients recruited from general practitioner will receive the standard medical care Receives: Procedure: Standard medical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of antibiotic for acute cystitis without risk of complication
Measured: Day 14 after inclusion (day 0)
Secondary outcomes (3)
Score at the "Activity Impairment Assessment" scale
Scale from 0 (never) to 4 (always) on several items about usuals activities limitations.
Measured: Day 0, Day 5 and Day14
Score at the satisfaction scale
Scale from 0 (not satisfied) to 10 (very satisfied) on satisfation about medical care.
Measured: Day 0, Day 5, Day14 and Day 90
Recurrence of the infection
Infection reccurence will be assessed with the number of dispensation of antibiotics between day 15 and day 90.
Measured: Between Day 15 and Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start22 Jul 2020
- Primary completion3 Dec 2021
- Study completion17 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 CystitisStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04272281
- Sponsor's protocol ID
- CHUBX 2017/48
- Other IDs
- 2019-A02354-53
- Acronym
- ARIBO
- Status last verified
- Mar 2022
- First submitted
- 14 Feb 2020
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guillaume Dumont, Jean-Philippe Joseph, Thomas Ferte, Pierre Poulizac, Marion Kret, Guillaume Conort, Yves-Marie Vincent ; Cystitis: Clinical Findings and Diagnostic Uncertainty in General Practice Results From a Cluster-Randomised Controlled Trial ; International Journal of Clinical Pratice ; March 2026 ; Research Gate : DOI:10.1155/ijcp/6710022
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilisation d'un Outil de décision médicale partagée Dans la Prise en Charge Des Cystites Aigues Sans Risque de Complication en médecine générale : Comparaison de la Consommation d'Antibiotique Entre Deux Groupes randomisés en Cluster.
- ClinicalTrials.gov ID
- NCT04272281
- Acronym / sponsor ID
- ARIBO / CHUBX 2017/48
- Conditions
- Cystitis
- Keywords
- primary health care, share decision making, antibiotics, daily activities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 22 Jul 2020 (actual)
- Primary completion
- 3 Dec 2021 (actual)
- Study completion
- 17 Feb 2022 (actual)
- First posted
- 17 Feb 2020 (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.
the aim of this trial is to demonstrate that when caring women with symptoms of acute cystitis without any risk of complication, general practitioner may use share decision making tool to help patients better understand the stakes of taking antibiotics.
Detailed description
Each year, more than 2.000.000 patients visit their general practitioners for a acute cystitis. The scientific literature shows that acute cystitis without risk of complication cause complications, such as pyelonephritis, in a very rare cases. However, French guidelines systematically request an antibiotic therapy as soon as the diagnostic is confirmed with the only goal to lowering symptomatology.
Recent studies show that some informed women would like not to take antibiotics and pain-killers could be as effective as antibiotics. Canadian studies assessing share decision making tools in patients with acute respiratory infection have shown that matching antibiotic treatment with the patient values lower such prescription without any impact on clinical outcomes .
Investigators aim to assess a similar strategy in patients with acute cystitis. This study will compare a group following French guidelines versus one using a share decision making tool to determine if, after being informed of the benefice and risk of this treatment, patient still want an antibiotic. Targeting instead of systematic prescription will reduce antibiotic consumption.
After diagnostic of acute cystitis to a woman between 18 and 65 years, investigators check if they filing all study criteria and ask for authorization to add them to the study. Then they'll act following their group instruction, and get information (antibiotic prescription or not, score to the Activity Impairment Assessment (AIA) scale, Score to satisfaction scale). Then patients will be followed by phone contact on day 5, day 14 and day 90 after inclusion to get information on antibiotic use, AIA and satisfaction scores and clinical outcomes, such urinary infection. Data on antibiotics delivery by pharmacy will be obtained through National assurance database.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Share making tool decision | Experimental | Procedure: medical shared decisionPatient recruited from general practitioner in this group will use a share making tool decision to adapt antibiotherapy |
| Standard recommandation | Active comparator | Procedure: Standard medical carePatients recruited from general practitioner will receive the standard medical care |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- woman
- between 18 and 65 years
- symptom of acute cystitis without risk of complication
- affiliated to the French public welfare system
- with signed consent
Key exclusion criteria (9 listed)
- anomaly of the urinary canal
- pregnancy
- more than 3 cystitis during the last year
- cancer, immunosuppression
- hemopathy, fever
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 |
|---|---|---|
| medical shared decisionThe experimental group will use the share decision making tool during consultation to adapt antibiotherapy | Procedure or surgery | Share making tool decision |
| Standard medical carecontrol group will act as usual in their practice. | Procedure or surgery | Standard recommandation |
Primary outcome
Use of antibiotic for acute cystitis without risk of complication
Time frame: Day 14 after inclusion (day 0)
3 secondary outcomes
Score at the "Activity Impairment Assessment" scale
Time frame: Day 0, Day 5 and Day14
Score at the satisfaction scale
Time frame: Day 0, Day 5, Day14 and Day 90
Recurrence of the infection
Time frame: Between Day 15 and Day 90
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 27 May 2026.
- Results publicationGuillaume Dumont, Jean-Philippe Joseph, Thomas Ferte, Pierre Poulizac, Marion Kret, Guillaume Conort, Yves-Marie Vincent ; Cystitis: Clinical Findings and Diagnostic Uncertainty in General Practice Results From a Cluster-Randomised Controlled Trial ; International Journal of Clinical Pratice ; March 2026 ; Research Gate : DOI:10.1155/ijcp/6710022
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing medical shared decision and Standard medical care in people with Cystitis, run by University Hospital, Bordeaux 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 5 inclusion and 9 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 27 May 2026. 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?
Use of antibiotic for acute cystitis without risk of complication (time frame: Day 14 after inclusion (day 0)). 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 NCT04272281, 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 27 May 2026.