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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cystitis Acute
• Intervention / Treatment: Other: Pharmacist management

• Study Type: Interventional
• Enrollment (Estimated): 480
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Arthur Piraux, PharmD, PhD; Phone Number: +33 0241226732; Email: arthur.piraux@univ-angers.fr
• Study Contact Backup: Name: Anthéa Loiez; Phone Number: +33 0241353637; Email: anthea.loiez@chu-angers.fr

Study Locations

• France
  • Bourgneuf-en-retz, France, 44580
    • Recruiting
    • Pharmacie du Pays De Retz
    • Contact: Benjamin CORCELLE
  • Bretignolles-sur-Mer, France
    • Recruiting
    • Pharmacie du Clocher
    • Contact: Vincent BARRETEAU
  • Brûlon, France
    • Recruiting
    • Pharmacie de Brûlon
    • Contact: Sandrine GASNIER
  • Chantonnay, France
    • Recruiting
    • Pharmacie du Centre
    • Contact: Nathalie BRETAUD
  • Chemazé, France
    • Recruiting
    • Pharmacie Degueille
    • Contact: Benoît DEGUEILLE
  • Chemillé-Melay, France, 49120
    • Recruiting
    • Pharmacie Nicolleau-Dilé
    • Contact: Nathalie Dilé
  • Craon, France
    • Recruiting
    • Pharmacie des Halles
    • Contact: Marion PARIS
  • Fontenay-le-Comte, France
    • Recruiting
    • Pharmacie Principale Harel
    • Contact: Catherine HAREL
  • La Ferté-Bernard, France
    • Recruiting
    • Pharmacie de la Place
    • Contact: Yann LESAINT
  • Le Mans, France
    • Recruiting
    • Pharmacie de Gazonfier
    • Contact: Pierre BRUGUIERE
  • Le Mans, France
    • Recruiting
    • Pharmacie de la Pointe
    • Contact: Antoine MACE
  • Le May-sur-Èvre, France
    • Recruiting
    • Pharmacie du Centre
    • Contact: Isabelle BARDOUIL
  • Les Sables-d'Olonne, France
    • Recruiting
    • Pharmacie Leeuws-Guilloton
    • Contact: Louis-Marie LEEUWS
  • Mesquer, France
    • Recruiting
    • Pharmacie de la Presqu'île
    • Contact: Thierry Guyon
  • Mûrs-Erigné, France
    • Recruiting
    • Pharmacie du Louet
    • Contact: Aurélie HERLIN
  • Noyen-sur-Sarthe, France
    • Recruiting
    • Pharmacie Flotté
    • Contact: Camille FLOTTE
  • Nozay, France
    • Recruiting
    • Pharmacie des Arcades
    • Contact: Philippe GRANDON
  • Pont Saint-martin, France
    • Recruiting
    • Pharmacie de la Place
    • Contact: Maël DRAPEAU
  • Roeze-sur-sarthe, France
    • Recruiting
    • Pharmacie Deroche
    • Contact: Sophie DEROCHE
  • Saint-Philbert-de-Bouaine, France
    • Recruiting
    • Pharmacie des Glycines
    • Contact: Fanny THOMAS
  • Sainte-anne Sur Brivet, France
    • Recruiting
    • Pharmacie Llacuna
    • Contact: Maud LLACUNA
  • Saumur, France
    • Recruiting
    • Pharmacie du Chemin Vert
    • Contact: Caroline DAVID
  • Soucelles, France
    • Recruiting
    • Pharmacie des Rives du Loir
    • Contact: Loïc MOISAN
  • Sougé-le-Ganelon, France
    • Recruiting
    • Pharmacie de la Source
    • Contact: Christelle GAUVRIT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.
No Intervention: 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.

What is the study measuring?

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
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
Recurrence of a urinary tract infection within 3 months (M3)	Number of cystitis encountered	At 3 months
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients' satisfaction	Satisfaction measured by a Likert scale. The minimum value is 0 and the maximun value is 27. A higher score mean good outcome	At 10 days
Pharmacists' satisfaction	Satisfaction measured by a Likert scale. The minimum value is 0 and the maximun value is 51. A higher score mean good outcome	through study completion, an average of 12 months
Pharmacists' experience	We will conduct semi-structured interviews with investigator pharmacyst who want's it We will explore Pharmacists' experience on the clinical research participation, including its Strengths, Weaknesses, Opportunities, and Threats.	through study completion, an average of 12 months
Patients' care overall satisfaction	Satisfaction measured by a Likert scale. The minimum value is 0 and the maximun value is 10. A higher score mean good outcome	At 10 days

Collaborators and Investigators

• Sponsor: University Hospital, Angers
• Collaborators: Direction Générale de l'Offre de Soins; Agence régionale de santé, région Pays de la Loire; Union régionale des professionnels de santé Pharmacien, région Pays de la Loire
• Investigators: Principal Investigator: Sébastien Faure, Professor, University of Angers; Study Director: Aline Ramond-Roquin, Professor, University of Angers

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2023
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): October 30, 2024

Study Registration Dates

• First Submitted: July 20, 2022
• First Submitted That Met QC Criteria: August 18, 2022
• First Posted (Actual): August 22, 2022

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Cystitis
• Other Study ID Numbers: 49RC22_0240

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No