Ibuprofen Versus Mecillinam for Uncomplicated Cystitis (IMUTI)

Ibuprofen Versus Mecillinam for Uncomplicated Cystitis in Adult, Non-pregnant Women

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.

Study Overview

• Status: Completed
• Conditions: Acute Cystitis (Excl in Pregnancy)
• Intervention / Treatment: Drug: Ibuprofen; Drug: Mecillinam

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 383
• Phase: Phase 4

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway
    • University of Oslo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ibuprofen; Tablet, over capsulated, 600mg three times a day for three days.	Drug: Ibuprofen; Other Names: Ibux
Active Comparator: Mecillinam; Tablet, over capsulated, 200mg three times a day for three days.	Drug: Mecillinam; Other Names: Selexid; Penomax

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients who are symptom free by day four	Both symptom load with regard to specific symptoms and when feeling completely symptom free will be registered in the patient diary.	Four days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The patients' symptom load with regard to specific symptoms.	Specific symptoms, such as dysuria, urgency and pollakiuria, will be given a number from 0-6 in the patient diary, 0 = no problem and 6= as bad as it can get.	Seven days

Other Outcome Measures

Outcome Measure	Time Frame
Proportion of patients who were in need of a secondary medical consult within the study period.	28 days
Proportion of patients who developed an upper urinary tract infection (pyelonephritis).	14 days
Proportion of patients who experienced severe adverse effects.	Seven days
Proportion of patients who had a relapse of symptoms within four weeks after being included in the study.	28 days
Proportion of patients with a positive urine culture after four weeks.	28 days

Collaborators and Investigators

• Sponsor: University of Oslo
• Collaborators: Lund University; University of Copenhagen; University of Bergen
• Investigators: Principal Investigator: Morten Lindbæk, Professor, University of Oslo, faculty of medicine, institute for health and society, department of general medicine, antibiotic centre of primary care

Publications and helpful links

General Publications

• Vik I, Mdala I, Bollestad M, Cordoba GC, Bjerrum L, Neumark T, Damsgaard E, Baerheim A, Grude N, Lindbaek M. Predicting the use of antibiotics after initial symptomatic treatment of an uncomplicated urinary tract infection: analyses performed after a randomised controlled trial. BMJ Open. 2020 Aug 30;10(8):e035074. doi: 10.1136/bmjopen-2019-035074.
• Vik I, Bollestad M, Grude N, Baerheim A, Damsgaard E, Neumark T, Bjerrum L, Cordoba G, Olsen IC, Lindbaek M. Ibuprofen versus pivmecillinam for uncomplicated urinary tract infection in women-A double-blind, randomized non-inferiority trial. PLoS Med. 2018 May 15;15(5):e1002569. doi: 10.1371/journal.pmed.1002569. eCollection 2018 May.
• Vik I, Bollestad M, Grude N, Baerheim A, Molstad S, Bjerrum L, Lindbaek M. Ibuprofen versus mecillinam for uncomplicated cystitis--a randomized controlled trial study protocol. BMC Infect Dis. 2014 Dec 17;14:693. doi: 10.1186/s12879-014-0693-y.

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: April 4, 2013
• First Submitted That Met QC Criteria: May 6, 2013
• First Posted (Estimate): May 9, 2013

Study Record Updates

• Last Update Posted (Actual): November 6, 2017
• Last Update Submitted That Met QC Criteria: November 1, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Cystitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Anti-Bacterial Agents; Anti-Infective Agents, Urinary; Renal Agents; Ibuprofen; Amdinocillin
• Other Study ID Numbers: UiO_IMUTI