Effectiveness of a pharmacist-led protocol to manage cystitis in women, in France: the PharmaCyst' open-label, multicenter, randomized, controlled, cluster study.

BACKGROUND

During their lifetime, more than half of all women will have a urinary tract infection. In many countries, due to difficulty accessing a general practitioner, community pharmacists can prescribe drugs for uncomplicated cystitis.

OBJECTIVE

This study evaluated the effectiveness of a pharmacist-led protocol compared to usual care (over-the-counter drugs, lifestyle, referral to a physician) for managing uncomplicated cystitis in women presenting to community pharmacies.

METHODS

The PharmaCyst' open-label, multicenter, controlled, cluster-randomized study was conducted in 24 community pharmacies in the Loire region, France. Women aged 18 to 65 years presenting to a pharmacy with at least one symptom of uncomplicated cystitis were considered for inclusion. They were assigned to the intervention arm or the control arm depending on their pharmacy (i.e. clusters). The primary endpoint was the score change in the 'typical symptoms' section of the Acute Cystitis Symptom Score (ACSS), between day 0 (intervention) and day 3. Patients were contacted by telephone at day 3, day 10, and month 3 post-intervention.

RESULTS

144 patients were included: 24 in the control arm and 120 in the intervention arm. The ACSS 'typical symptoms' score reduction at day 3 was greater in the intervention than control arm (-8.21 vs -5.84 points, p = 0.035). No difference in the occurrence of adverse events or complications was observed between arms. Patient overall satisfaction with the care provided by community pharmacists was excellent (mean score: 9.66 of 10).

CONCLUSION

Pharmacists' management of cystitis in women leads to a greater reduction in symptoms at day 3.