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

Not Applicable

Terminated

• Conditions: Cystitis Acute
• Interventions: Other: Pharmacist management

• Registration Number: NCT05510128
• Lead Sponsor: University Hospital, Angers

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-20
• Study First Submitted QC: 2022-08-18
• Study First Posted: 2022-08-22
• Study Start: 2023-06-30
• Primary Completion: 2024-10-29
• Status Verified: 2025-01
• Study Completion: 2025-01-29
• Last Update Submitted: 2025-01-30
• Last Update Posted: 2025-02-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 145

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Management with the protocol	Pharmacist management	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.

Primary Outcome Measures

Name	Time	Method
The evolution of the symptoms at D3	Enrollment, Day 3	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

Secondary Outcome Measures

Name	Time	Method
Use of a medical consultation or an emergency service	At 10 days	Nature of consultations provided
Performing a urine culture	At 3 days and 10 days	Number of urine culture performed
Taking medication to relieve the symptoms of the infection	Day 10	Nature of medication used
Occurrence of an adverse event at D3 and D10	At 3 days	Nature of adverse events
The evolution of the symptoms at D10	Enrollment, Day 10	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
Performing a urine dipstick	Enrollment, Day 3, Day 10	Number of urine dipstick performed
Recurrence of a urinary tract infection within 3 months (M3)	At 3 months	Number of cystitis encountered

Trial Locations

Locations (14)

Pharmacie de la Source; 🇫🇷 Sougé-le-Ganelon, France

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; 🇫🇷 Roeze-sur-sarthe, France

Pharmacie Llacuna; 🇫🇷 Sainte-anne Sur Brivet, France

Pharmacie du Chemin Vert; 🇫🇷 Saumur, France