Assessment of UTI Symptoms and Quality of Life According to Antibiotics Treatment in Acute Uncomplicated Cystitis

Soon Chun Hyang University

Status: Completed

Conditions: Acute Cystitis

Treatments: Drug: Ciprobay

Study type: Observational

Funder types: Other

Identifiers

NCT01631955

KAUTII&Schbc-UTI-QoL

Details and patient eligibility

About

Although Cystitis includes a clinical syndrome characterized by various combinations of dysuria (painful urination), frequency, urgency, gross haematuria, lower back and/or abdominal/suprapubic discomfort with pyuria and bacteriuria. An acute uncomplicated UTI (referred to as cystitis) has been focused microorganisms and drug-resistance. There has been little research on Clinical aspects on cystitis treatment such as bothersomeness, or the impact of symptoms on patients' quality of life (QoL). The investigators want to study for Assessment of UTI Symptoms and Quality of Life According to Antibiotics Treatment(Ciprobay) in Acute Uncomplicated Cystitis in Korean Women.

Enrollment: 386 patients

Sex: Female

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female outpatients (20-65 years old)
• Acute cystitis symptoms (subject-reported) for < 1 week prior to Visit 1.

Exclusion criteria

• Acute cystitis symptoms for ≥ 1 week prior to Visit 1.
• Diabetes mellitus
• Congenital urinary tract abnormality
• Female subjects who are pregnant, nursing, or with a positive urine pregnancy test or who are intending to become pregnant during the study or within 3 months after the completion of the study.
• Hypersensitivity to the active substance (Ciprobay).
• Subjects who have vaginal discharge
• Fever ( ≥ 37.5 ºC)
• Sexually transmitted diseases.
• Documented significant renal disease (sCr > 1.5)
• Subjects who cannot consent to this study.
• Subjects who had received antimicrobial agents in the previous 4 weeks.
• Recurrent urinary tract infection defined as treatment for UTI > 3 times in the last year.
• Use of an indwelling catheter or an intermittent self-catheterization program.
• Neurogenic bladder.

Trial design

386 participants in 1 patient group

Cystitis

Description:

female with cystitis symptoms

Treatment:

Drug: Ciprobay