An interventional study of medical shared decision and Standard medical care in Cystitis, sponsored by University Hospital, Bordeaux. Completed at 1 site in France. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-05-27.
Sponsored by University Hospital, Bordeaux · Not applicable, Interventional, and Treatment
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.
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.
69 studies on the registry are indexed under Cystitis; 17 are open to participants now.
This study's enrollment of 169 is above the median of 112 across 50 interventional studies indexed under Cystitis.
Browse Cystitis studies →University Hospital, Bordeaux is the lead sponsor of 806 studies on the registry; 197 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patient recruited from general practitioner in this group will use a share making tool decision to adapt antibiotherapy
Procedure: medical shared decision
Patients recruited from general practitioner will receive the standard medical care
Procedure: Standard medical care
The experimental group will use the share decision making tool during consultation to adapt antibiotherapy
control group will act as usual in their practice.
Use of antibiotic for acute cystitis without risk of complication
Time frame: Day 14 after inclusion (day 0)
Score at the "Activity Impairment Assessment" scale
Scale from 0 (never) to 4 (always) on several items about usuals activities limitations.
Time frame: 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.
Time frame: 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.
Time frame: Between Day 15 and Day 90
Plan to share: No
Ran from Jul 2020 to primary completion in Dec 2021, 16 months.
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This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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