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

NCT ID: NCT01631955

Last Updated: 2012-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

386 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-10-31

Study Completion Date

2011-10-31

Brief Summary

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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

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Conditions

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Acute Cystitis

Keywords

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Acute cystitis Antibiotics Quality of life

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Cystitis

female with cystitis symptoms

Ciprobay

Intervention Type DRUG

Ciprobay (250mg, bid, oral)

Interventions

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Ciprobay

Ciprobay (250mg, bid, oral)

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Soonchunhyang University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kwang-Woo Lee, MD

Department of urology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Min-Eui Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Soonchunhyang University Hospital

Locations

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Soonchunhyang University Bucheon Hospital

Bucheon-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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KAUTII&Schbc-UTI-QoL

Identifier Type: -

Identifier Source: org_study_id