Evaluation of the Effectiveness of a Protocol for the Management of Female Functional Urinary Signs (PharmaCyst')

University Hospital, Angers

Status: Terminated

Conditions: Cystitis Acute

Treatments: Other: Pharmacist management

Study type: Interventional

Funder types: Other

Identifiers

NCT05510128

49RC22_0240

Details and patient eligibility

About

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.

Enrollment: 145 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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145 participants in 2 patient groups

Management with the protocol

Experimental group

Description:

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.

Treatment:

Other: Pharmacist management

Standard care

No Intervention group

Description:

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.