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

Acute Cystitis Clinical Trial

Official title:

A Study of Quality of Life and Changes to Symptom Relief for Acute Uncomplicated Cystitis Treated With Antibiotics (Ciprobay); Prospective, Open-label, Multicenter, Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01631955
• Other study ID #: KAUTII&Schbc-UTI-QoL
• Status: Completed
• Phase: N/A
• First received: June 27, 2012
• Last updated: June 28, 2012
• Start date: October 2009
• Est. completion date: October 2011

Study information

• Verified date: June 2012
• Source: Soonchunhyang University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 386
• Est. completion date: October 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 65 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Cystitis
• Cystitis

Intervention

Drug:
• Ciprobay
Ciprobay (250mg, bid, oral)

Locations

Country	Name	City	State
Korea, Republic of	Soonchunhyang University Bucheon Hospital	Bucheon	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Soonchunhyang University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect on patient satisfaction and quality of life.		at day 5 relative to baseline	No
Secondary	Change in UTISA sub-category (dysuria, frequency, urgency, pain, hematuria)		at day 10, 21 and 28 relative to baseline	No
Secondary	Change in KHQ		at day 10, 21 and 28 relative to baseline	No