Post-market surveillance study to evaluate tolerability, acceptance, improvement in quality of life and the course of symptoms in patients suffering from an acute uncomplicated urinary tract infection and receiving supportive treatment with Femannose®

• Conditions: N30.0; N39.0; Acute cystitis; Urinary tract infection, site not specified

• Registration Number: DRKS00016632
• Lead Sponsor: Cassella-med GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-29
• Study Completion: 2019-07-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 103

Inclusion Criteria

Signed informed consent (data protection)
- Female outpatients aged =18 years with acute uncomplicated urinary tract infection

Exclusion Criteria

- Patients <18 years (children and adolescents)
- Patients with contraindications according to user manual:
- known hypersensitivity to D-mannose or to any of the other ingredients of Femannose® N

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is the percentage of patients healed, which is defined as the percentage of patients with score reduction to 0 or 1 in burning / pain during urination” on Day 7 or end of study (if earlier), documented in the patient’s diary.