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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01631955
Other study ID # KAUTII&Schbc-UTI-QoL
Secondary ID
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 ÂșC)

- 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


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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT03517215 - The Development and Testing of a Scaling Strategy for a Community-Based Primary Care Antimicrobial Stewardship Program N/A