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

Primary Purpose

Cystitis Acute

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Pharmacist management
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cystitis Acute

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

  • Pharmacie du Pays De RetzRecruiting
  • Pharmacie du Clocher
  • Pharmacie de Brûlon
  • Pharmacie du Centre
  • Pharmacie Degueille
  • Pharmacie Nicolleau-Dilé
  • Pharmacie des HallesRecruiting
  • Pharmacie Principale Harel
  • Pharmacie de la PlaceRecruiting
  • Pharmacie de Gazonfier
  • Pharmacie de la Pointe
  • Pharmacie du Centre
  • Pharmacie Leeuws-Guilloton
  • Pharmacie de la Presqu'île
  • Pharmacie du Louet
  • Pharmacie Flotté
  • Pharmacie des Arcades
  • Pharmacie de la Place
  • Pharmacie DerocheRecruiting
  • Pharmacie des Glycines
  • Pharmacie LlacunaRecruiting
  • Pharmacie du Chemin Vert
  • Pharmacie des Rives du Loir
  • Pharmacie de la Source

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Management with the protocol

Standard care

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 20, 2022
Last Updated
August 3, 2023
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
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1. Study Identification

Unique Protocol Identification Number
NCT05510128
Brief Title
Evaluation of the Effectiveness of a Protocol for the Management of Female Functional Urinary Signs
Acronym
PharmaCyst'
Official Title
Evaluation of the Effectiveness of the Application of a Protocol for the Management of Female Functional Urinary Signs in French Community Pharmacies
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 29, 2023 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the 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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystitis Acute

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
480 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Management with the protocol
Arm Type
Experimental
Arm 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.
Arm Title
Standard care
Arm Type
No Intervention
Arm 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.
Intervention Type
Other
Intervention Name(s)
Pharmacist management
Intervention Description
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.
Primary Outcome Measure Information:
Title
The evolution of the symptoms at D3
Description
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
Time Frame
Enrollment, Day 3
Secondary Outcome Measure Information:
Title
The evolution of the symptoms at D10
Description
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
Time Frame
Enrollment, Day 10
Title
Use of a medical consultation or an emergency service
Description
Number of consultations provided
Time Frame
At 3 days
Title
Use of a medical consultation or an emergency service
Description
Nature of consultations provided
Time Frame
At 10 days
Title
Performing a urine dipstick
Description
Number of urine dipstick performed
Time Frame
Enrollment, Day 3, Day 10
Title
Performing a urine culture
Description
Number of urine culture performed
Time Frame
At 3 days and 10 days
Title
Taking medication to relieve the symptoms of the infection
Description
Number of medication used
Time Frame
Enrollment,
Title
Taking medication to relieve the symptoms of the infection
Description
Nature of medication used
Time Frame
Day 3,
Title
Taking medication to relieve the symptoms of the infection
Description
Nature of medication used
Time Frame
Day 10
Title
Occurrence of an adverse event at D3 and D10
Description
Number of adverse events
Time Frame
At 10 days
Title
Occurrence of an adverse event at D3 and D10
Description
Nature of adverse events
Time Frame
At 3 days
Title
Recurrence of a urinary tract infection within 3 months (M3)
Description
Number of cystitis encountered
Time Frame
At 3 months
Other Pre-specified Outcome Measures:
Title
Patients' satisfaction
Description
Satisfaction measured by a Likert scale. The minimum value is 0 and the maximun value is 27. A higher score mean good outcome
Time Frame
At 10 days
Title
Pharmacists' satisfaction
Description
Satisfaction measured by a Likert scale. The minimum value is 0 and the maximun value is 51. A higher score mean good outcome
Time Frame
through study completion, an average of 12 months
Title
Pharmacists' experience
Description
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.
Time Frame
through study completion, an average of 12 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Gender identity
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arthur Piraux, PharmD, PhD
Phone
0241226732
Ext
+33
Email
arthur.piraux@univ-angers.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Anthéa Loiez
Phone
0241353637
Ext
+33
Email
anthea.loiez@chu-angers.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sébastien Faure, Professor
Organizational Affiliation
University of Angers
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Aline Ramond-Roquin, Professor
Organizational Affiliation
University of Angers
Official's Role
Study Director
Facility Information:
Facility Name
Pharmacie du Pays De Retz
City
Bourgneuf-en-retz
ZIP/Postal Code
44580
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benjamin CORCELLE
Facility Name
Pharmacie du Clocher
City
Bretignolles-sur-Mer
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent BARRETEAU
Facility Name
Pharmacie de Brûlon
City
Brûlon
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Pharmacie du Centre
City
Chantonnay
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Pharmacie Degueille
City
Chemazé
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Pharmacie Nicolleau-Dilé
City
Chemillé-Melay
ZIP/Postal Code
49120
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Pharmacie des Halles
City
Craon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marion PARIS
Facility Name
Pharmacie Principale Harel
City
Fontenay-le-Comte
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Pharmacie de la Place
City
La Ferté-Bernard
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yann LESAINT
Facility Name
Pharmacie de Gazonfier
City
Le Mans
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Pharmacie de la Pointe
City
Le Mans
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Pharmacie du Centre
City
Le May-sur-Èvre
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabelle BARDOUIL
Facility Name
Pharmacie Leeuws-Guilloton
City
Les Sables-d'Olonne
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Pharmacie de la Presqu'île
City
Mesquer
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thierry Guyon
Facility Name
Pharmacie du Louet
City
Mûrs-Erigné
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Pharmacie Flotté
City
Noyen-sur-Sarthe
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Camille FLOTTE
Facility Name
Pharmacie des Arcades
City
Nozay
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Pharmacie de la Place
City
Pont Saint-martin
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Pharmacie Deroche
City
Roeze-sur-sarthe
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie DEROCHE
Facility Name
Pharmacie des Glycines
City
Saint-Philbert-de-Bouaine
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Pharmacie Llacuna
City
Sainte-anne Sur Brivet
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maud LLACUNA
Facility Name
Pharmacie du Chemin Vert
City
Saumur
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Pharmacie des Rives du Loir
City
Soucelles
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Pharmacie de la Source
City
Sougé-le-Ganelon
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christelle GAUVRIT

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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