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

NCT ID: NCT05510128

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 145 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-30
• Study Completion Date: 2025-01-29

Brief Summary

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.

Conditions

Cystitis Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Management with the protocol

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.

Group Type: EXPERIMENTAL

Pharmacist management

Intervention Type: OTHER

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.

Standard care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Pharmacist management

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

agence régionale de santé Pays de la Loire

UNKNOWN

Sponsor Role: collaborator

union régionale des professionnels de santé pharmaciens libéraux Pays de la Loire

UNKNOWN

Sponsor Role: collaborator

Direction Générale de l'offre de Soins (DGOS)

UNKNOWN

Sponsor Role: collaborator

University Hospital, Angers

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sébastien Faure, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Angers

Aline Ramond-Roquin, Professor

Role: STUDY_DIRECTOR

University of Angers

Locations

Pharmacie du Pays De Retz

Bourgneuf-en-Retz, , France

Pharmacie de Brûlon

Brûlon, , France

Pharmacie Degueille

Chemazé, , France

Pharmacie Nicolleau-Dilé

Chemillé-Melay, , France

Pharmacie des Halles

Craon, , France

Pharmacie de la Place

La Ferté-Bernard, , France

Pharmacie de la Pointe

Le Mans, , France

Pharmacie du Centre

Le May-sur-Èvre, , France

Pharmacie du Louet

Mûrs-Erigné, , France

Pharmacie des Arcades

Nozay, , France

Pharmacie Deroche

Roézé-sur-Sarthe, , France

Pharmacie Llacuna

Sainte-Anne-sur-Brivet, , France

Pharmacie du Chemin Vert

Saumur, , France

Pharmacie de la Source

Sougé-le-Ganelon, , France

Countries

France

Other Identifiers

49RC22_0240

Identifier Type: -

Identifier Source: org_study_id