N30.0 N39.0
Conditions
Interventions
Group 1: intake of Femannose N
In the scope of this observational study no intervention is planned. The recommendation of intake of Femannose® N will take place before and regardless of the participa
Sponsors
Cassella-med GmbH & Co. KG
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Signed informed consent (data protection) - Female outpatients aged =18 years with acute uncomplicated urinary tract infection
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Efficacy Endpoints: - Percentage of patients symptom-free, i.e. complete resolution of typical UTI symptoms, defined as the fulfilment of the following three prerequisites: oSymptom ”burning / pain during urination” with score “0” or “1” o“Urination frequency” answered with “not more often” or “hardly more often” oQuestions to “urination of only small amounts”, “Continuous urge to urinate” and “Observing a change in urine”, all answered with ”No” - Global judgement of efficacy assessed by the physician as excellent or good (percentage) - The QoL score: The QoL score is defined as the sum-score of the two questions regarding the degree of restrains of a.) daily activities and b.) social activities due to UTI symptoms. The respective analyses will be performed for the oCourse of QoL oCourse in scores separately for questions a.) and b.) above - First day of symptom-free - First time/day of symptom improvement - First day of healing. Healing is defined as symptom “burning / pain during urination” with score of “0” or “1” - Patient assessment of the question: “Will you use Femannose® N in the future?” - Percentage of patients receiving treatment with medical device under investigation for the subgroups: in combination with antibiotics; in combination with another treatment/measure for acute UTI other than antibiotics; without another treatment / measure; Subgroup Analysis for Efficacy Endpoints: Sub-group analyses for primary and secondary efficacy endpoints will be performed for patients receiving treatment with Femannose® N: a.)In combination with antibiotics b.)In combination with another treatment/measure of/for acute urinary tract infection other than antibiotics c.)Without another medication and comparing subgroup a.) versus c.) and b.) versus c.) using adequate statistical test procedures Only subgroups with a sufficient number of patients (n>10) will be analysed. Secondary Tolerability Endpoints: - Type, frequency and severity of ADE - G | — |
Countries
Germany
Contacts
Public ContactBettina Schopf
Pharmalog Institut für klinische Forschung GmbH
Outcome results
None listed