TerminatedPhase 4

Symptomatic Therapy of Uncomplicated Lower Urinary Tract Infections in the Ambulatory Setting.

Stopped: New power calculation (reduction of necessary patient number)

Switzerland253 participantsStarted 2012-02

Plain-language summary

We propose to perform a randomized controlled patient and assessor blind trial in women between the ages of 18 to 70 years with acute uncomplicated UTI to evaluate initial symptomatic treatment for 3 days with the non-steroidal anti-inflammatory drug diclofenac (experimental intervention) against immediate antibiotic treatment with norfloxacin for 3 days (control intervention). Both interventions are followed by optional delayed antibiotic treatment with single dose fosfomycin if deemed necessary by the patients. The primary objective is to determine whether initial symptomatic treatment followed by optional delayed antibiotic treatment (experimental intervention) is non-inferior to immediate antibiotic treatment (control intervention) in terms of symptom resolution.

Who can participate

Age range

18 Years – 70 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Female * Age between 18 and 70 years * Written informed consent * At least one typical symptom of acute, lower urinary tract infection out of dysuria, frequency, macrohaematuria, cloudy or smelly urine or self-diagnosed cystitis * A urine dipstick test should be indicative of UTI by positive nitrite or leucocyturia Exclusion Criteria * Duration of UTI symptoms for more than 7 days before physician's visit * Clinical signs of invasiveness such as fever (axillary body temperature \>38 degrees Celsius), costovertebral pain or tenderness, rigors, nausea or vomiting * Known or suspicion of anatomical or functional abnormality of the urinary tract * Vaginal symptoms: discharge, irritation * Diabetes mellitus * Immunosuppression (e.g. prednisone equivalent \>10mg per day for \>14 days, chemotherapy, radiotherapy, immunomodulators, HIV infection, neutropenia) * Any other serious comorbidity as judged by the treating physician * Bladder catheter in situ or during the past 30 days * Pregnancy * Recurrent urinary tract infection (more than 3 infections during the last 12 months) * Antibiotic treatment during the last 4 weeks * Hypersensitivity to one of the study medications * Psychiatric illness or dementia * Unable to communicate in German or French language * Documented coagulopathy (including therapy with coumarine derivatives) or documented history of gastric or duodenal ulcer disease * Documented renal insufficiency grade III or higher (calculated GFR \<60…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The proportion of patients with resolution of symptoms on day 4

Timeframe: one month

Trial details

NCT IDNCT01039545

SponsorInsel Gruppe AG, University Hospital Bern

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-12

View on ClinicalTrials.gov More Urinary Tract Infections trials