An interventional study of Share making decision tool and Delegation protocol in Acute Cystitis, sponsored by University Hospital, Bordeaux. Recruiting at 26 sites in France. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by University Hospital, Bordeaux · Not applicable, Interventional, and Treatment
The purpose of this trial is to demonstrate that when treating acute cystitis without risk of complication, pharmacists may use share Decision Making tool to help patients to better understand the stakes of taking antibiotics and adapt the management of the delegation protocol.
This will select patients in need of antibiotics and preserve the full-capacities of non-treated one.
Each year, in France, more than 2.000.000 patients visit for a acute cystitis. The literature shows that acute cystitis without risk of complication cause pyelonephritis only on really rare situation, but french delegation protocols to pharmacist ask for systematic antibiotic therapy as soon as the diagnostic is made with the only goal to lowering symptomatology. Studies shows that some informed women would like not to take antibiotics while others studies show us that pain-killers could be as effective as antibiotics on case of low symptomatology.
This study will compare a group following only the French protocols for delegating acute cystitis to the pharmacist with a group using the same protocol, but supplementing it with a shared decision-making tool to determine whether, after being informed of the benefits and risks of this treatment, patients still wish to receive 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 informations (antibiotic prescription or not, patient socio-demographic criteria). Then patients will be followed by telephone on D14 to know if they've take antibiotics and to obtain the following information: AIA scale, O'Connor Scale, Satisfaction scale, if there has been visit to the emergency room or doctor. Antibiotics delivery on pharmacy will be watch by National assurance number of the included patients
69 studies on the registry are indexed under Cystitis; 17 are open to participants now.
This study's planned enrollment of 506 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.
woman, between 18 and 65 years, coming to a pharmacy randomized in the experimental group for symptom of acute cystitis without risk of complication
Other: Share making decision tool
woman, between 18 and 65 years, coming to a pharmacy randomized in the control group for symptom of acute cystitis without risk of complication
Other: Delegation protocol
the experimental group will apply the delegation protocol, but if the protocol recommends antibiotic therapy, the researchers will propose a shared decision using a specific tool to determine with the patient whether to deliver the antibiotic
the control group will apply the delegation protocol alone
Dispensing of antibiotic
Dispensing of antibiotic for acute cystitis without risk of complication on the 14 days following the first visit to the pharmacy.
Time frame: day 14 after inclusion
Activity Impairment Assessment(AIA) scale
5-item ranging from 0 (no impact) to 4 (constant impact). It has no sub-dimensions and allows for an overall assessment (sum of the scores for each item) ranging from 0 (no discomfort/no incapacity) to 20 (total discomfort/ total incapacity).
Time frame: day 14 after inclusion
Satisfaction scale
Satisfaction score on a scale from 0 (dissatisfaction) to 10 (total satisfaction)
Time frame: day 14 after inclusion
O'Connor scale
16-item scale rated from 1 to 5. Each score is converted to a base of 100 (1=0, 5=100). The total average of the items out of 100 determines: \< 25: Low conflict - the person is probably ready to make a decision. 25-37.5: Moderate conflict - some discomfort may still exist. ≥ 37.5: High conflict - the person probably needs help deciding.
Time frame: day 14 after inclusion
Medical consultation
Consultations with a doctor or at the emergency room for urinary tract infection and/or possible complications among patients diagnosed with uncomplicated cystitis within two weeks of visiting the pharmacy (telephone survey at two weeks).
Time frame: day 14 after inclusion
Plan to share: No
No publications or documents are linked to this record.
Started May 2026 (actual). Primary completion is estimated for Nov 2026, 6 months after the start.
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