Urinary NGF as A Biomarker for Acute Bacterial Cystitis (NCT01800799) | Clinical Trial Compass
CompletedNot Applicable
Urinary NGF as A Biomarker for Acute Bacterial Cystitis
Taiwan37 participantsStarted 2013-02
Plain-language summary
This study will enroll 30 female patients with the first time urinary tract infection (UTI), 30 female patients with recurrent UTI and 10 female without any prior history of UTI or urinary tract pathology will be invited to serve as the controls. Urine samples will be collected in the patients at baseline, 7 days after antibiotics treatment, and 2 weeks, 4 weeks, 8 weeks, and 12 weeks. Urinalysis will be performed at each visit and urine culture will be performed at baseline and at the 2 weeks and 3 months visits. Urine samples at baseline and 3 months will be collected from the controls for comparison.
Who can participate
Age range
20 Years – 90 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 adults aged ≥ 20 years.
* All patients should be proven to have UTI by detecting pyuria in urinalysis (WBC\>10 per high power field) and had a positive urine culture result.
* A KUB film, and renal sonography will be performed to exclude to possibility of urolithiasis or other urinary tract pathology.
* Not yet have lower urinary tract surgery in the past.
* The patient has not yet accepted anticholinergic medication
* Patient or his legally acceptable representative has signed the written informed consent form.
Exclusion Criteria:
* Patients with severe cardiopulmonary disease and such as congestive heart failure, arrhythmia, poorly controlled hypertension, not able to receive regular follow-up.
* Patients with uncontrolled confirmed diagnosis of acute urinary tract infection.
* Patients have laboratory abnormalities at screening including: (1) Aspartate aminotransferase (AST) \> 3 x upper limit of normal range. (2) Alanine aminotransferase (ALT) \> 3 x upper limit of normal range. (3) Patients have abnormal serum creatinine level \> 2 x upper limit of normal range.
* Female patients who is pregnant, lactating, or with child-bearing potential without contraception.
* Patients with any other serious disease or condition considered by the investigator not suitable for entry into the trial.
* Patients participated investigational drug trial within 1 month before entering this study.
* Patient or his legally written informed consent hadn't been ob…
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
1
Change from Baseline in urinary nerve growth factor (NGF) at different time points