Uncomplicated cystitis in adult, non pregnant women, age 18-60. MedDRA version: 14.1 Level: LLT Classification code 10000699 Term: Acute cystitis (excl in pregnancy) System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Ibuprofen ratiopharm
Pharmaceutical Form: Tablet
Trade Name: Selexid
Pharmaceutical Form: Tablet
Sponsors
University of Oslo, Faculty of medicine, Institute of Health and Society
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Woman between 18 and 60 years of age. Dysuria and urinary frequency and/or urinary urgency. Ability to speak, understand and write Norwegian/Swedish/Danish and ability to give consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 400 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Pregnancy/breastfeeding child under one month of age Diabetes Kidney disease or use of the drug probenecid Clinical suspicion of pyelonefritis; fever, reduced general condition, upper back pain Vaginal symptoms such as discharge or irritation Severe abdominal pain Symptoms that have lasted for more than seven days One or more urinary tract infections within the lasts four weeks Permanent bladder catheter or use of bladder catheter within the last four weeks Use of antibiotics within the last two weeks Previous allergic reaction to penicillin Previous allergic reaction to ibuprofen, or worsening of asthma when taking NSAIDs Narrow oesophagus Severe gastritis or previous ulcer Anticoagulative treatment Ongoing use of steroids Use of immunosuppressant drugs Thrombocytopenia Heart insufficiency Severe psychiatric illness or dementia Severe drug addiction Unable to communicate in Norwegian, Swedish or Danish language
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Although uncomplicated cystitis is considered to be a mild condition and mostly self limiting, most patients who see a doctor will be treated with antibiotics. Antibiotics are known to give a quick relief of symptoms and shorten the course of the condition by a few days. The aim of this study is to evaluate ibuprofen versus mecillinam in the treatment of uncomplicated cystitis in otherwise healthy, non-pregnant women. Our main objective is to see whether symptomatic treatment with ibuprofen is equally efficiant as treatment with mecillinam in this group. ;Secondary Objective: Will it take longer for the patients in the ibuprofen group to feel well? Are there more complications in the ibuprofen group compared to the mecillinam group? Are they more likely to develop an upper urinary tract infection? Are they more likely to develop a second uncomplicated cystitis within the four weeks of follow up? Are there more positive urine cultures in the ibuprofen group after two weeks?;Primary end point(s): Proportion of patients who feel cured by day four as registered in the patient diary;Timepoint(s) of evaluation of this end point: Four days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The patients’ symptom load with regard to specific symptoms. Proportion of patients who had a relapse of symptoms of uncomplicated cystitis within the study period. Proportion of patients who were in need of a secondary medical consult within the study period. Proportion of patients who developed an upper urinary tract infection (pyelonefritis). Proportion of patients who experienced severe adverse effects. Proportion of patients with a positive urine culture after two weeks. ;Timepoint(s) of evaluation of this end point: Four weeks | — |
Countries
Denmark, Norway, Sweden
Contacts
Public ContactIngvild Vik
University of Oslo
Outcome results
None listed