Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2019-A02354-53 | Other Identifier | ANSM |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Share making tool decision | Experimental | Patient recruited from general practitioner in this group will use a share making tool decision to adapt antibiotherapy |
|
| Standard recommandation | Active Comparator | Patients recruited from general practitioner will receive the standard medical care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| medical shared decision | Procedure | The experimental group will use the share decision making tool during consultation to adapt antibiotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Use of antibiotic for acute cystitis without risk of complication | Day 14 after inclusion (day 0) |
| Measure | Description | Time Frame |
|---|---|---|
| Score at the "Activity Impairment Assessment" scale | Scale from 0 (never) to 4 (always) on several items about usuals activities limitations. | Day 0, Day 5 and Day14 |
| Score at the satisfaction scale |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Bordeaux | Bordeaux | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003556 | Cystitis |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Standard medical care | Procedure | control group will act as usual in their practice. |
|
Scale from 0 (not satisfied) to 10 (very satisfied) on satisfation about medical care.
| 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. | Between Day 15 and Day 90 |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |