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

Completed

• Conditions: Acute Cystitis
• Interventions: Drug: Ciprobay

• Registration Number: NCT01631955
• Lead Sponsor: Soonchunhyang University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Primary Completion: 2011-02
• Study Completion: 2011-10
• Status Verified: 2012-06
• Study First Submitted: 2012-06-27
• Study First Submitted QC: 2012-06-28
• Last Update Submitted: 2012-06-28
• Study First Posted: 2012-06-29
• Last Update Posted: 2012-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 386

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cystitis	Ciprobay	female with cystitis symptoms

Primary Outcome Measures

Name	Time	Method
Effect on patient satisfaction and quality of life.	at day 5 relative to baseline

Secondary Outcome Measures

Name	Time	Method
Change in UTISA sub-category (dysuria, frequency, urgency, pain, hematuria)	at day 10, 21 and 28 relative to baseline
Change in KHQ	at day 10, 21 and 28 relative to baseline

Trial Locations

Locations (1)

Soonchunhyang University Bucheon Hospital; 🇰🇷 Bucheon, Gyeonggi-do, Korea, Republic of