Category
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Primary study
Registry of Trials»ISRCTN registry
Year
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2015
INTERVENTION: Current interventions as of 13/09/2016: Participants are asked to accept a delayed prescription for antibiotics and then are randomly allocated into one of four groups: Group 1 – Uva Ursi 1200mg tds + advice to take ibuprofen Group 2 – placebo tds + advice to take ibuprofen Group 3 – Uva Ursi 1200mg tds + no advice to take ibuprofen Group 4 ‐ placebo tds + no advice to take ibuprofen. If their symptoms get worse or have not improved after 3‐5 days participants will start taking their antibiotics. Severity of symptoms is recorded using a diary and the proportion of women using antibiotics in each group measured. Follow Up Length: 3 month(s); Study Entry : Single Randomisation only Previous interventions: 1. Ibuprofen, 400mg tds 2. Placebo, tds 3. Uva ursi, 1200mg tds Follow Up Length: 3 month(s); Study Entry : Single Randomisation only CONDITION: Topic: Primary Care; Subtopic: Infectious diseases and microbiology, Primary care; Disease: All Diseases ; Infections and Infestations PRIMARY OUTCOME: Symptom severity day 2‐4 using validated diary data INCLUSION CRITERIA: 1. Adult women (18‐70) presenting to primary care with suspected lower urinary tract infection i.e. with at least one of dysuria, urgency or frequency 2. Patient able to provide informed written consent 3. Women willing to accept a delayed prescription for antibiotics SECONDARY OUTCOME: Current secondary outcome measures as of 19/09/2016:; 1. Use of antibiotics ‐ participant records in their diary if they took the antibiotics prescribed at the time of their initial consultation. ; 2. Duration of moderately bad symptoms – patients record the severity of a range of urinary symptoms on a daily basis using a validated scoring system from the day of randomisation until all symptoms have resolved. ; The symptoms are: fever, pain in the side, blood in urine, smelly urine, burning (burning or pain when passing urine), urgency (having to go in a hurry), day time frequency (having to go more often than usual during the day), night time frequency (having to go more often than usual during the night), tummy pain (when not passing urine), restricted activities, unwell. The scoring system is: 0 = Normal/not affected, 1 = Very little problem, 2 = Slight problem, 3 = Moderately bad, 4 = Bad, 5 = Very bad, 6 = As bad as it could be; 3. Total symptom burden derived from diary data; 4. Re‐consultation in 1 month with UTI from notes review ; 5. Re‐consultation in 3 months with UTI from notes review ?; ; Previous secondary outcome measures:; 1. The use of antibiotics – whether the participant had to use the delayed prescription given to them by the GP at the time of their initial consultation when they were randomised to the trial. This will be recorded in their participant diary; 2. Duration of moderately bad symptoms – patients record the severity of a range of urinary symptoms on a daily basis using a validated scoring system from the day of randomisation until all symptoms have resolved. The symptoms are: fever, pain in the side, blood in urine, smelly urine, burning (burning or pain when passing urine), urgency (having to go in a hurry), day time frequency (having to go more often than usual during the day), night time frequency (having to go more often than usual during the night), tummy pain (when not passing urine), restricted activities, unwell. The scoring system is: 0 = Normal/not affected, 1 = Very little problem, 2 = Slight problem, 3 = Moderately bad, 4 = Bad, 5 = Very bad, 6 = As bad as it could be; 3. Re‐consultation with UTI within the 3‐month period following randomisation. This will be determined at the 3 months note review carried out by the GP; 4. Exploratory Analysis: Differential effects on primary outcome depending on urinary culture results
Epistemonikos ID: 698dbf9be754e120274337d2edcc571bde38dea1
First added on: Aug 23, 2024