Are antibiotics really necessary to treat urinary tract infections in women or can support be offered with pain relief?
| ISRCTN | ISRCTN88111427 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88111427 |
| EudraCT/CTIS number | 2016-003442-87 |
| Secondary identifying numbers | NUIG-2016-02 |
- Submission date
- 24/03/2017
- Registration date
- 17/05/2017
- Last edited
- 01/12/2017
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Urological and Genital Diseases
Plain English Summary
Background and study aims
A urinary tract infection (UTI) is a common type of infection that affects the urinary system. They are more common in women than men and cause a range of symptoms, including needing to urinate more often or pain when passing urine. Many patients visit their GP for treatment, which usually involves having to take antibiotics. Some research has shown however that many women with UTI symptoms will recover without antibiotic treatment. This study is looking at whether treating the symptoms of a UTI, such as pain, inflammation (swelling) and fever is a suitable alternative to treatment with antibiotics. The aim of this study is to find out whether treating the symptoms of UTIs with pain killers limits the need for antibiotic treatment.
Who can participate?
Women who own a smartphone and have been diagnosed with a UTI by their GP.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group take nitrofurantoin (an antibiotic used to treat UTIs) capsules four times a day for three days. Those in the second group take ibuprofen (a pain killer) capsules four times a day for three days. Participants in both groups download a smartphone app which includes a diary that women record how bad their symptoms are twice a day while they are being treated. Participants are also telephoned after four and 28 days in order to find out how their recovery is going.
What are the possible benefits and risks of participating?
It is expected that the treatment given will improve the symptoms of UTI but this is not guaranteed. The information gained from this study may help lead to the development of new treatments for UTI and it may benefit patients in the future. Sometimes, UTIs can develop into a more serious infection. This risk is very small, but is probably slightly higher in UTIs that are not treated with antibiotics. Also, symptoms may be experienced for a day longer in the ibuprofen group.
Where is the study run from?
The study is run from the Discipline of General Practice, National University of Ireland and takes place in 20 GP Practices (Ireland)
When is the study starting and how long is it expected to run for?
January 2016 to December 2018
Who is funding the study?
Health Research Board (Ireland)
Who is the main contact?
Dr Akke Vellinga
akke.vellinga@nuigalway.ie
Contact information
Public
National University of Ireland
1 Distillery Road
Galway
-
Ireland
 ORCID ID |
0000-0002-6583-4300 |
|---|---|
| Phone | +335 (0)91 495194 |
| akke.vellinga@nuigalway.ie |
Study information
| Study design | Double-blind twoarm randomised parallel trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | www.primarycaretrials.ie/satin |
| Scientific title | Ibuprofen versus nitrofurantoin for uncomplicated urinary tract infection – a randomised parallel trial study |
| Study acronym | SATIN |
| Study hypothesis | The aim of this study is to evaluate whether initial symptomatic treatment limits the need for antibiotics for uncomplicated urinary tract infections (UTIs) in adult, non-pregnant women. |
| Ethics approval(s) | Research Ethics Committee of The Irish College of General Practitioners |
| Condition | Uncomplicated urinary tract infection |
| Intervention | Participants will receive either immediate treatment with nitrofurantoin 50mg, four times daily, or initial symptomatic treatment with ibuprofen 400mg, four times daily for three days. The original tablets of nitrofurantoin and ibuprofen will be over-encapsulated with gelatine capsules for blinding purposes. Because ibuprofen 400mg tablets are too large to over-encapsulate, two 200mg capsules will be produced. Since there is only one nitrofurantoin tablet, a second dummy capsule will be produced. Capsules will be topped up or filled only with placebo made of Lactose/Magnesium stearate. A treatment kit with two opaque bottles will be made for each patient. Each patient treatment pack will contain a bottle with 12 capsules of nitrofurantoin and a bottle of 12 capsules of placebo or two bottles 12 capsules containing ibuprofen each. Each kit will be labelled with a 6 digit treatment number. This labelling is done following a randomisation list using block randomisation. A smartphone app will be used to follow up the study participants at set times. Patients will be guided to download the SATIN UTI diary app during enrolment and the first entries will be made during the consultation. Subsequently, patients will be requested to record the severity of their symptoms twice a day, once during the morning (from 6 AM to 2 PM) with reminders set at 9, 10 and 11 AM and once in the afternoon (from 4 PM-11PM) with reminders set at 6, 7 and 8 PM. A telephone call will be made to all patients on day 4 and day 28 (or as soon as possible after this day if this day falls in the weekend). The aim of the day 4 phone call is to make sure the patient is recovering. Additionally, treatment compliance, concomitant medications, UTI Symptom Score, adverse events and return consultation with a GP will be recorded. The purpose of the day 28 call is to collect information on any recurrences and longer term safety outcomes. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III/IV |
| Drug / device / biological / vaccine name(s) | 1. Ibuprofen 2. Nitrofurantoin |
| Primary outcome measure | Time to recovery with recovery, defined as a total score of <=1 across the symptoms dysuria, frequency, and urgency, as measured by a smartphone UTI diary app twice daily. |
| Secondary outcome measures | 1. The proportion of participants recovered on day 4, with recovery defined as a total score of <=1 across the symptoms dysuria, frequency and urgency, each rated on a 0-4 scale 2. The proportion of participants with symptom resolution on day 4, with resolution defined as a total score = 0 across the symptoms dysuria, frequency and urgency, each rated on a 0-4 scale 3. The proportion of participants who received the back-up antibiotics (change during their treatment or requested at the end of treatment) is assessed recorded on their clinical notes (Ecrf) at the time of an unplanned visit due to worsening of symptoms 4. The proportion of participants who received an antibiotic prescription in the 28 days after the initial consultation is measured during their day 28 follow up call by the research nurse 5. Symptom load during days 0-7 is measured by comparing areas under the curve over the first 7 days 6. Proportion of participants with UTI recurrences in the 28 days after the initial consultation is measured by during their day 28 follow up call by the research nurse 7. Symptom burden of individual symptoms (dysuria, urinary frequency and urgency) from day 0-7 comparing daily scores for each symptom between groups 8. Activity Impairment Assessment (AIA) day 0 and 5, analysed by comparison of the time to resume normal daily activities 9. Proportion of participants with adverse events in the 28 days after the initial consultation |
| Overall study start date | 01/01/2016 |
| Overall study end date | 31/12/2018 |
| Reason abandoned (if study stopped) | Objectives no longer viable |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 460 |
| Participant inclusion criteria | 1. GP- diagnosed urinary tract infection and at least one of the symptoms dysuria, urinary frequency, or urgency with/without low abdominal pain 2. Female 3. Aged 18 years or above 4. Able and willing to give written informed consent and to comply with the requirements of this study protocol 5. Smartphone ownership |
| Participant exclusion criteria | 1. Any sign of a complicated infection, such as loin pain, fever, rigors, malaise, or vomiting 2. Pregnancy/breastfeeding child 3. Non-use of a highly effective contraceptive measure if the woman is considered of childbearing potential (WOCBP). Contraception methods with low user dependency should be used. 4. Diabetes mellitus 5. Chronic kidney disease (CKD) defined as estimated Glomerular Filtration Rate (eGFR) <60ml/min/1.73m2 or acute kidney injury, defined as any previously documented eGFR <60ml/min/1.73m2 6. Disease, anatomical abnormality or previous surgery of kidney or urinary tract 7. One or more urinary tract infections within the last four weeks 8. Permanent bladder catheter or use of bladder catheter within the last four weeks 9. Use of antibiotics within the last two weeks 10. Use of other investigational drugs within the last 30 days prior to screening 11. Concomitant use of NSAIDs and aspirin 12. Previous pyelonephritis 13. Acute porphyria Previous adverse reaction or hypersensitivity to ibuprofen, or worsening of asthma when using non-steroidal anti-inflammatory drugs 14. Previous adverse reaction to nitrofurantoin or other nitrofurans or fosfomycin 15. Current use of proton-pump inhibitor or H2 receptor blocker 16. Previous upper gastrointestinal bleed or perforation 17. Glucose 6 Phosphate Dehydrogenase deficiency 18. Severe heart failure (NYHA Class IV) or hepatic failure 19. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption 20. Known allergy to azo colouring agents 21. Inability to follow instructions or comply with follow-up procedures 22. Any other medical condition(s) that may put the participant at risk or influence the study results in the investigator’s opinion or the investigator deems unsuitable for the study |
| Recruitment start date | 01/05/2017 |
| Recruitment end date | 01/05/2018 |
Locations
Countries of recruitment
- Ireland
Study participating centre
School of Medicine
Galway
-
Ireland
Sponsor information
University/education
University Road
Galway
-
Ireland
"ROR" |
https://ror.org/00shsf120 |
|---|
Funders
Funder type
Research organisation
Government organisation / Local government
- Alternative name(s)
- Health Research Board, Ireland, An Bord Taighde Sláinte, HRB
- Location
- Ireland
Results and Publications
| Intention to publish date | 31/12/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication of the results of the trial as well as any other results in high-impact peer reviewed journals. |
| IPD sharing plan | The current data sharing plans for the current study are unknown and will be made available at a later date. |
Editorial Notes
01/12/2017: This study was terminated on 14/11/2017.
12/07/2017: Internal edit.
