Ibuprofen Versus Mecillinam for Uncomplicated Cystitis (IMUTI)

University of Oslo

Status and phase

Completed

Phase 4

Conditions

Acute Cystitis (Excl in Pregnancy)

Treatments

Drug: Ibuprofen

Drug: Mecillinam

Study type

Interventional

Funder types

Other

Identifiers

NCT01849926

UiO_IMUTI

Details and patient eligibility

About

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 efficient as treatment with mecillinam in this group.

Full description

The design of the study will be a double blinded randomized controlled trial (RCT). Half of the patients will receive treatment with mecillinam and the other half will receive treatment with ibuprofen. The study will follow the principles of Good Clinical Practice (GCP).

Urine cultures will be obtained on day one and after two weeks. The patients will be given a diary where they daily will register symptom load, possible complications or adverse effects and on which day they feel completely cured. We will contact the patients after two weeks to make sure they have followed the study procedures. After four weeks we will perform a final interview with the patient.

Enrollment

383 patients

Sex

Female

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

woman between 18 and 60 years of age
dysuria and pollakiuria and/or urinary urgency
ability to give written consent

Exclusion criteria

pregnancy/breastfeeding child under one month of age
diabetes
kidney disease
organic aciduria
clinical suspicion of pyelonephritis; 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
participated in a clinical trial within the last four weeks
previously undergone a pyelonephritis
previous allergic reaction to penicillin
previous allergic reaction to ibuprofen, or worsening of asthma when using nonsteroidal antiinflammatory drugs(NSAIDs)
narrow oesophagus
use of the drug probenecid
severe gastritis or previous ulcer
anticoagulative treatment
ongoing use of steroids
use of immunosuppressant drugs
thrombocytopenia,
Chrohn's disease or Ulcerative colitis
heart insufficiency
severe psychiatric illness or dementia
severe drug addiction
unable to communicate in Norwegian, Swedish or Danish language