Symptomatic treatment of uncomplicated lower urinary tract infections in the ambulatory setting: randomised, double blind trial

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Abstract

Objective To investigate whether symptomatic treatment with non-steroidal anti-inflammatory drugs (NSAIDs) is non-inferior to antibiotics in the treatment of uncomplicated lower urinary tract infection (UTI) in women, thus offering an opportunity to reduce antibiotic use in ambulatory care.

Design Randomised, double blind, non-inferiority trial.

Setting 17 general practices in Switzerland.

Participants 253 women with uncomplicated lower UTI were randomly assigned 1:1 to symptomatic treatment with the NSAID diclofenac (n=133) or antibiotic treatment with norfloxacin (n=120). The randomisation sequence was computer generated, stratified by practice, blocked, and concealed using sealed, sequentially numbered drug containers.

Main outcome measures The primary outcome was resolution of symptoms at day 3 (72 hours after randomisation and 12 hours after intake of the last study drug). The prespecified principal secondary outcome was the use of any antibiotic (including norfloxacin and fosfomycin as trial drugs) up to day 30. Analysis was by intention to treat.

Results 72/133 (54%) women assigned to diclofenac and 96/120 (80%) assigned to norfloxacin experienced symptom resolution at day 3 (risk difference 27%, 95% confidence interval 15% to 38%, P=0.98 for non-inferiority, P<0.001 for superiority). The median time until resolution of symptoms was four days in the diclofenac group and two days in the norfloxacin group. A total of 82 (62%) women in the diclofenac group and 118 (98%) in the norfloxacin group used antibiotics up to day 30 (risk difference 37%, 28% to 46%, P<0.001 for superiority). Six women in the diclofenac group (5%) but none in the norfloxacin group received a clinical diagnosis of pyelonephritis (P=0.03).

Conclusion Diclofenac is inferior to norfloxacin for symptom relief of UTI and is likely to be associated with an increased risk of pyelonephritis, even though it reduces antibiotic use in women with uncomplicated lower UTI.

Trial registration ClinicalTrials.gov NCT01039545.

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Most cited references 30

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The results of direct and indirect treatment comparisons in meta-analysis of randomized controlled trials.

H. C. Bucher, G H Guyatt, L Griffith … (1997)

When little or no data directly comparing two treatments are available, investigators often rely on indirect comparisons from studies testing the treatments against a control or placebo. One approach to indirect comparison is to pool findings from the active treatment arms of the original controlled trials. This approach offers no advantage over a comparison of observational study data and is prone to bias. We present an alternative model that evaluates the differences between treatment and placebo in two sets of clinical trials, and preserves the randomization of the originally assigned patient groups. We apply the method to data on sulphamethoxazole-trimethoprim or dapsone/pyrimethamine as prophylaxis against Pneumocystis carinii in HIV infected patients. The indirect comparison showed substantial increased benefit from the former (odds ratio 0.37, 95% CI 0.21 to 0.65), while direct comparisons from randomized trials suggests a much smaller difference (risk ratio 0.64, 95% CI 0.45 to 0.90; p-value for difference of effect = 0.11). Direct comparisons of treatments should be sought. When direct comparisons are unavailable, indirect comparison meta-analysis should evaluate the magnitude of treatment effects across studies, recognizing the limited strength of inference.

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Ibuprofen versus fosfomycin for uncomplicated urinary tract infection in women: randomised controlled trial

Ildikó Gágyor, Jutta Bleidorn, Michael Kochen … (2015)

Study question Can treatment of the symptoms of uncomplicated urinary tract infection (UTI) with ibuprofen reduce the rate of antibiotic prescriptions without a significant increase in symptoms, recurrences, or complications? Methods Women aged 18-65 with typical symptoms of UTI and without risk factors or complications were recruited in 42 German general practices and randomly assigned to treatment with a single dose of fosfomycin 3 g (n=246; 243 analysed) or ibuprofen 3×400 mg (n=248; 241 analysed) for three days (and the respective placebo dummies in both groups). In both groups additional antibiotic treatment was subsequently prescribed as necessary for persistent, worsening, or recurrent symptoms. The primary endpoints were the number of all courses of antibiotic treatment on days 0-28 (for UTI or other conditions) and burden of symptoms on days 0-7. The symptom score included dysuria, frequency/urgency, and low abdominal pain. Study answer and limitations The 248 women in the ibuprofen group received significantly fewer course of antibiotics, had a significantly higher total burden of symptoms, and more had pyelonephritis. Four serious adverse events occurred that lead to hospital referrals; one of these was potentially related to the trial drug. Results have to be interpreted carefully as they might apply to women with mild to moderate symptoms rather than to all those with an uncomplicated UTI. What this paper adds Two thirds of women with uncomplicated UTI treated symptomatically with ibuprofen recovered without any antibiotics. Initial symptomatic treatment is a possible approach to be discussed with women willing to avoid immediate antibiotics and to accept a somewhat higher burden of symptoms. Funding, competing interests, data sharing German Federal Ministry of Education and Research (BMBF) No 01KG1105. Patient level data are available from the corresponding author. Patient consent was not obtained but the data are anonymised and risk of identification is low. Trial registration No ClinicalTrialGov Identifier NCT01488955.

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Effectiveness of five different approaches in management of urinary tract infection: randomised controlled trial

J P Little, Christine Moore, S S Turner … (2010)

Objective To assess the impact of different management strategies in urinary tract infections. Design Randomised controlled trial. Setting Primary care. Participants 309 non-pregnant women aged 18-70 presenting with suspected urinary tract infection. Intervention Patients were randomised to five management approaches: empirical antibiotics; empirical delayed (by 48 hours) antibiotics; or targeted antibiotics based on a symptom score (two or more of urine cloudiness, urine smell, nocturia, or dysuria), a dipstick result (nitrite or both leucocytes and blood), or a positive result on midstream urine analysis. Self help advice was controlled in each group. Main outcome measures Symptom severity (days 2 to 4) and duration, and use of antibiotics. Results Patients had 3.5 days of moderately bad symptoms if they took antibiotics immediately. There were no significant differences in duration or severity of symptoms (mean frequency of symptoms on a 0 to 6 scale: immediate antibiotics 2.15, midstream urine 2.08, dipstick 1.74, symptom score 1.77, delayed antibiotics 2.11; likelihood ratio test for the five groups P=0.177). There were differences in antibiotic use (immediate antibiotics 97%, midstream urine 81%, dipstick 80%, symptom score 90%, delayed antibiotics 77%; P=0.011) and in sending midstream urine samples (immediate antibiotics 23%, midstream urine 89%, dipstick 36%, symptom score 33%, delayed antibiotics 15%; P<0.001). Patients who waited at least 48 hours to start taking antibiotics reconsulted less (hazard ratio 0.57 (95% confidence interval 0.36 to 0.89), P=0.014) but on average had symptoms for 37% longer than those taking immediate antibiotics (incident rate ratio 1.37 (1.11 to 1.68), P=0.003), particularly the midstream urine group (73% longer, 22% to 140%; none of the other groups had more than 22% longer duration). Conclusion All management strategies achieve similar symptom control. There is no advantage in routinely sending midstream urine samples for testing, and antibiotics targeted with dipstick tests with a delayed prescription as backup, or empirical delayed prescription, can help to reduce antibiotic use. Study registration National Research Register N0484094184 ISRCTN: 03525333.

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Author and article information

Contributors

Andreas Kronenberg: Role: senior lecturer

Lukas Bütikofer: Role: senior statistician

Ayodele Odutayo: Role: postdoctoral fellow

Kathrin Mühlemann: Role: professor

Bruno R da Costa: Role: assistant professor and associate director

Markus Battaglia: Role: primary care physician

Damian N Meli: Role: primary care physician

Peter Frey: Role: consultant

Andreas Limacher: Role: consultant

Stephan Reichenbach: Role: associate professor and attending physician

Peter Jüni: Role: professor and director

Journal

Journal ID (nlm-ta): BMJ

Journal ID (iso-abbrev): BMJ

Journal ID (publisher-id): bmj

Title: The BMJ

Publisher: BMJ Publishing Group Ltd.

ISSN (Print): 0959-8138

ISSN (Electronic): 1756-1833

Publication date Collection: 2017

Publication date (Electronic): 08 November 2017

Volume: 359

Electronic Location Identifier: j4784

Affiliations

[1 ]Institute for Infectious Diseases, University of Bern, Bern, Switzerland

[2 ]Department of Infectious Diseases, Bern University Hospital, University of Bern, Bern, Switzerland

[3 ]Medix General Practice Network, Bern, Switzerland

[4 ]CTU Bern, University of Bern, Bern, Switzerland

[5 ]Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland

[6 ]Applied Health Research Centre, Li Ka Shing Knowledge Institute of St Michael’s Hospital, Department of Medicine and Institute of Health Policy, Management and Evaluation, University of Toronto, Canada

[7 ]Institute of Primary Health Care, University of Bern, Bern, Switzerland

[8 ]Department of Rheumatology, Immunology and Allergology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland

Author notes

Correspondence to: A Kronenberg andreas.kronenberg@ 123456ifik.unibe.ch

Article

Publisher ID: krona039317

DOI: 10.1136/bmj.j4784

PMC ID: 5672899

PubMed ID: 29113968

SO-VID: 36770cff-e058-4137-b7fc-4ac3441af1bf

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This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

Symptomatic treatment of uncomplicated lower urinary tract infections in the ambulatory setting: randomised, double blind trial

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Most cited references 30

The results of direct and indirect treatment comparisons in meta-analysis of randomized controlled trials.

Ibuprofen versus fosfomycin for uncomplicated urinary tract infection in women: randomised controlled trial

Effectiveness of five different approaches in management of urinary tract infection: randomised controlled trial

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