Evaluation of the Effectiveness of a Protocol for the Management of Female Functional Urinary Signs

Study Overview
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Brief Summary
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Every year, between 4 and 6 million French people are affected by a urinary infection; the vast majority of these are women. Although the diagnosis of an uncomplicated urinary tract infection is simple to make, it requires prompt medical management to relieve the symptoms. The lack of immediate of a physician can slow down the management of patients affected by this condition, and lead to an inappropriate referral of patients to the emergency services. Because of their wide availability, accessibility, and geographical distribution throughout the country, pharmacists are primary health care professionals who are regularly called upon to respond to patients with this type of infection. A national protocol exists in France, but it is very difficult to apply. The PharmaCyst' study aims to evaluate its application in community pharmacies.

Official Title
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Evaluation of the Effectiveness of the Application of a Protocol for the Management of Female Functional Urinary Signs in French Community Pharmacies

Conditions
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Cystitis Acute

Intervention / Treatment
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* Other: Pharmacist management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female Age ≥ 18 and <65 years Patient with less than 3 days of simple urinary tract infection symptoms: Burning, pain on urination Dysuria Pollakiuria Urinary urgency Patient affiliated or beneficiary of a social insurance Patient having signed an informed consent. Exclusion Criteria: More than 3 cystitis in the last 12 months; Last cystitis less than 15 days old; Presence of fever; Presence of back pain; Presence of a functional or organic anomaly of the urinary tract (bladder residue, vesico-ureteral reflux, lithiasis, tumor); Pruritus or vaginal discharge; Vomiting, diarrhea, diffuse abdominal pain; Risk factors for C3G-resistant enterobacteria infection (grade B): Exposure to an antibiotic (amoxicillin-clavulanic acid, C2G, C3G, fluoroquinolones) within the previous 3 months; A nosocomial or healthcare-associated infection; A history of colonization or infection with C3G-resistant enterobacteria within the last 3 months; A trip to a foreign country within the last 3 months in known geographical areas at risk (in particular the Indian subcontinent, South-East Asia, the Middle East and North Africa, the Mediterranean basin); Hospitalization within 3 months; Hospitalization within 6 months for UTI; Known severe renal insufficiency (creatinine clearance < 30 mL/min); Severe immunosuppression or immunosuppressive treatments; Contraindications to drugs planned for experimental management (pivmecillinam and fosfomycin) or combination of drugs not recommended; Pregnant women (confirmed or suspected pregnancy), breastfeeding women or women in labour; Person deprived of liberty by judicial or administrative decision; Person under forced psychiatric care; Person admitted to a health or social institution for purposes other than research; Person subject to a legal protection measure; A person who is unable to give consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Management with the protocol<br>Patients who participate in the study in the experimental arm benefit from an adapted management, which falls under the application of the national cooperation protocol. This management may lead to the dispensing of an antibiotic by the pharmacist himself. | Other: Pharmacist management<br>* When a patient comes to the pharmacy with signs of urinary burning, the following will follow: Completion of the acute cystitis symptoms score (ACSS) questionnaire. Measure the temperature. Perform a urine dipstick. If the patient's temperature is normal, the urine dipstick is positive, and the absence of pain in the lumbar fossa is verified, the pharmacist can dispense an appropriate antibiotic himself. A reminder of the hygienic-dietary rules is also issued, and a communication to the patient's general practitioner will be made.<br>|
| No Intervention: Standard care<br>Patients participating in the study in the control arm will benefit from a management comparable to the current one. In addition to a reminder of the hygienic and dietary rules by the pharmacist, the patient may be offered a drug indicated for improving urinary comfort. The pharmacist should also remind the patient that she can consult a doctor, especially in case of non relief or aggravation of symptoms. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The evolution of the symptoms at D3 | Difference in the score from the first part of the Acute Cystitis Symptome Score questionnaire. The minimum value is 0 and the maximun value is 18. A higher score mean worse outcome | Enrollment, Day 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The evolution of the symptoms at D10 | Difference in the score from the first part of the Acute Cystitis Symptome Score questionnaire. The minimum value is 0 and the maximun value is 18. A higher score mean worse outcome | Enrollment, Day 10 | 
| Use of a medical consultation or an emergency service | Number of consultations provided | At 3 days | 
| Use of a medical consultation or an emergency service | Nature of consultations provided | At 10 days | 
| Performing a urine dipstick | Number of urine dipstick performed | Enrollment, Day 3, Day 10 | 
| Performing a urine culture | Number of urine culture performed | At 3 days and 10 days | 
| Taking medication to relieve the symptoms of the infection | Number of medication used | Enrollment, | 
| Taking medication to relieve the symptoms of the infection | Nature of medication used | Day 3, | 
| Taking medication to relieve the symptoms of the infection | Nature of medication used | Day 10 | 
| Occurrence of an adverse event at D3 and D10 | Number of adverse events | At 10 days | 
| Occurrence of an adverse event at D3 and D10 | Nature of adverse events | At 3 days | 
| Recurrence of a urinary tract infection within 3 months (M3) | Number of cystitis encountered | At 3 months |