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

June 28, 2012 updated by: Kwang-Woo Lee, MD, Soonchunhyang University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

386

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Bucheon, Gyeonggi-do, Korea, Republic of, 420-767
        • SoonChunHyang University Bucheon Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Outpatient

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cystitis
female with cystitis symptoms
Drug: Ciprobay
Ciprobay (250mg, bid, oral)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Effect on patient satisfaction and quality of life.
Time Frame: at day 5 relative to baseline
at day 5 relative to baseline

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Soonchunhyang University Hospital

Investigators

  • Principal Investigator: Min-Eui Kim, MD, PhD, Soonchunhyang University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

June 27, 2012

First Submitted That Met QC Criteria

June 28, 2012

First Posted (Estimate)

June 29, 2012

Study Record Updates

Last Update Posted (Estimate)

June 29, 2012

Last Update Submitted That Met QC Criteria

June 28, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KAUTII&Schbc-UTI-QoL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Cystitis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kyrgyzstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe