Study Stopped
A premature termination was decided following the publication of the order authorizing the pharmacist to dispense antibiotics for simple cystitis in women. Thus the experimental practice of the study joins very strongly with the new practice.
Evaluation of the Effectiveness of a Protocol for the Management of Female Functional Urinary Signs
PharmaCyst'
1 other identifier
interventional
145
1 country
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2023
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 20, 2022
CompletedFirst Posted
Study publicly available on registry
August 22, 2022
CompletedStudy Start
First participant enrolled
June 30, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 29, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 29, 2025
CompletedMarch 13, 2026
March 1, 2026
1.3 years
July 20, 2022
March 11, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (11)
The evolution of the symptoms at D10
Enrollment, Day 10
Use of a medical consultation or an emergency service
At 3 days
Use of a medical consultation or an emergency service
At 10 days
Performing a urine dipstick
Enrollment, Day 3, Day 10
Performing a urine culture
At 3 days and 10 days
- +6 more secondary outcomes
Other Outcomes (5)
Patients' satisfaction
At 10 days
Patients' care overall satisfaction
At 10 days
Pharmacists' satisfaction
through study completion, an average of 12 months
- +2 more other outcomes
Study Arms (2)
Management with the protocol
EXPERIMENTALPatients 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.
Standard care
NO INTERVENTIONPatients 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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);
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Pharmacie du Pays De Retz
Bourgneuf-en-Retz, 44580, France
Pharmacie de Brûlon
Brûlon, France
Pharmacie Degueille
Chemazé, France
Pharmacie Nicolleau-Dilé
Chemillé-Melay, 49120, 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
Study Officials
- PRINCIPAL INVESTIGATOR
Sébastien Faure, Professor
University of Angers
- STUDY DIRECTOR
Aline Ramond-Roquin, Professor
University of Angers
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2022
First Posted
August 22, 2022
Study Start
June 30, 2023
Primary Completion
October 29, 2024
Study Completion
January 29, 2025
Last Updated
March 13, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- The data will be shared after signing a negotiated data transfer agreement ( data access agreement), for the duration specified in the agreement.
- Access Criteria
- The data will be made available via secure transfer (sharing platform approved by the university hospital: BlueFiles or Oodrive).
Data will be shared upon reasonable request. Only de-identified data will be shared. Any data collected during the study may be shared. The protocol will be shared initially. Other documents may be shared at a later date upon request (e.g., the CRF to allow a collaborator to select the data they wish to access). The recipients of the data will be researchers. The data will be available for any purpose deemed relevant by the study investigator, based on a protocol provided by the requester, after verification of the obtaining of regulatory approvals, including the favorable opinion of an ethics committee.