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

March 11, 2026 updated by: University Hospital, Angers

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
145

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Bourgneuf-en-Retz, France, 44580
        • Pharmacie du Pays De Retz
      • Brûlon, France
        • Pharmacie de Brûlon
      • Chemazé, France
        • Pharmacie Degueille
      • Chemillé-Melay, France, 49120
        • Pharmacie Nicolleau-Dilé
      • Craon, France
        • Pharmacie des Halles
      • La Ferté-Bernard, France
        • Pharmacie de la Place
      • Le Mans, France
        • Pharmacie de la Pointe
      • Le May-sur-Èvre, France
        • Pharmacie du Centre
      • Mûrs-Erigné, France
        • Pharmacie du Louet
      • Nozay, France
        • Pharmacie des Arcades
      • Roézé-sur-Sarthe, France
        • Pharmacie Deroche
      • Sainte-Anne-sur-Brivet, France
        • Pharmacie Llacuna
      • Saumur, France
        • Pharmacie du Chemin Vert
      • Sougé-le-Ganelon, France
        • Pharmacie de la Source

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 61 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The evolution of the symptoms at D3
Time Frame: 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
Enrollment, Day 3

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The evolution of the symptoms at D10
Time Frame: 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
Enrollment, Day 10
Performing a urine dipstick
Time Frame: Enrollment, Day 3, Day 10
Number of urine dipstick performed
Enrollment, Day 3, Day 10
Performing a urine culture
Time Frame: At 3 days and 10 days
Number of urine culture performed
At 3 days and 10 days
Recurrence of a urinary tract infection within 3 months (M3)
Time Frame: At 3 months
Number of cystitis encountered
At 3 months
Use of a medical consultation or an emergency service
Time Frame: At 3 days
Number of consultations provided
At 3 days
Use of a medical consultation or an emergency service
Time Frame: At 10 days
Nature of consultations provided
At 10 days
Taking medication to relieve the symptoms of the infection
Time Frame: Enrollment,
Number of medication used
Enrollment,
Taking medication to relieve the symptoms of the infection
Time Frame: Day 3,
Nature of medication used
Day 3,
Taking medication to relieve the symptoms of the infection
Time Frame: Day 10
Nature of medication used
Day 10
Occurrence of an adverse event at D3 and D10
Time Frame: At 10 days
Number of adverse events
At 10 days
Occurrence of an adverse event at D3 and D10
Time Frame: At 3 days
Nature of adverse events
At 3 days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patients' satisfaction
Time Frame: At 10 days
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
Time Frame: through study completion, an average of 12 months
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
Time Frame: through study completion, an average of 12 months
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
Time Frame: At 10 days
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
Overall satisfaction of patients
Time Frame: At 10 days
Overall satisfaction level of patients with the care provided in pharmacies. The minimum value is 0 and the maximun value is 10. A higher score mean good outcome
At 10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Angers

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Direction Générale de l'offre de Soins (DGOS)
agence régionale de santé Pays de la Loire
union régionale des professionnels de santé pharmaciens libéraux Pays de la Loire

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sébastien Faure, Professor, University of Angers
  • Study Director: Aline Ramond-Roquin, Professor, University of Angers

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 30, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 29, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 29, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 20, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 22, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 49RC22_0240

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

The data will be shared after signing a negotiated data transfer agreement ( data access agreement), for the duration specified in the agreement.

IPD Sharing Access Criteria

The data will be made available via secure transfer (sharing platform approved by the university hospital: BlueFiles or Oodrive).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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