Urinary NGF as A Biomarker for Acute Bacterial Cystitis

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Buddhist Tzu Chi General Hospital
• Treatments: Anti-Infective Agents; Anti-Inflammatory Agents; Celecoxib

Criteria

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 obtained.