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Completed

NCT Number: NCT04272281

Use of a Share Decision Making Tool in the Care of Acute Cystitis Without Risk of Complication in Primary Care

the aim of this trial is to demonstrate that when caring women with symptoms of acute cystitis without any risk of complication, general practitioner may use share decision making tool to help patients better understand the stakes of taking antibiotics.

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Bordeaux

Bordeaux, France

About this study

Each year, more than 2.000.000 patients visit their general practitioners for a acute cystitis. The scientific literature shows that acute cystitis without risk of complication cause complications, such as pyelonephritis, in a very rare cases. However, French guidelines systematically request an antibiotic therapy as soon as the diagnostic is confirmed with the only goal to lowering symptomatology.

Recent studies show that some informed women would like not to take antibiotics and pain-killers could be as effective as antibiotics. Canadian studies assessing share decision making tools in patients with acute respiratory infection have shown that matching antibiotic treatment with the patient values lower such prescription without any impact on clinical outcomes .

Investigators aim to assess a similar strategy in patients with acute cystitis. This study will compare a group following French guidelines versus one using a share decision making tool to determine if, after being informed of the benefice and risk of this treatment, patient still want an antibiotic. Targeting instead of systematic prescription will reduce antibiotic consumption.

After diagnostic of acute cystitis to a woman between 18 and 65 years, investigators check if they filing all study criteria and ask for authorization to add them to the study. Then they'll act following their group instruction, and get information (antibiotic prescription or not, score to the Activity Impairment Assessment (AIA) scale, Score to satisfaction scale). Then patients will be followed by phone contact on day 5, day 14 and day 90 after inclusion to get information on antibiotic use, AIA and satisfaction scores and clinical outcomes, such urinary infection. Data on antibiotics delivery by pharmacy will be obtained through National assurance database.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • woman
  • between 18 and 65 years
  • symptom of acute cystitis without risk of complication
  • affiliated to the French public welfare system
  • with signed consent

Exclusion criteria

  • anomaly of the urinary canal
  • pregnancy
  • more than 3 cystitis during the last year
  • cancer, immunosuppression
  • hemopathy, fever
  • back-pain
  • severe renal failure
  • refuse to give consent and previously participate to the study
  • under guardianship

Treatment and study plan

medical shared decision

Procedure

The experimental group will use the share decision making tool during consultation to adapt antibiotherapy

Standard medical care

Procedure

control group will act as usual in their practice.

Primary outcomes

  1. Use of antibiotic for acute cystitis without risk of complication

    Time frame: Day 14 after inclusion (day 0)

Secondary outcomes

  1. Score at the "Activity Impairment Assessment" scale

    Time frame: Day 0, Day 5 and Day14

    Scale from 0 (never) to 4 (always) on several items about usuals activities limitations.

  2. Score at the satisfaction scale

    Time frame: Day 0, Day 5, Day14 and Day 90

    Scale from 0 (not satisfied) to 10 (very satisfied) on satisfation about medical care.

  3. Recurrence of the infection

    Time frame: Between Day 15 and Day 90

    Infection reccurence will be assessed with the number of dispensation of antibiotics between day 15 and day 90.

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

Utilisation d'un Outil de décision médicale partagée Dans la Prise en Charge Des Cystites Aigues Sans Risque de Complication en médecine générale : Comparaison de la Consommation d'Antibiotique Entre Deux Groupes randomisés en Cluster.

Acronym: ARIBO

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Feb 17, 2020
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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