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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kwang-Woo Lee, MD, Soonchunhyang University Hospital
ClinicalTrials.gov Identifier:
NCT01631955
First received: June 27, 2012
Last updated: June 28, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Acute Cystitis
Drug: Ciprobay

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Soonchunhyang University Hospital:

Primary Outcome Measures:
  • Effect on patient satisfaction and quality of life. [ Time Frame: at day 5 relative to baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in UTISA sub-category (dysuria, frequency, urgency, pain, hematuria) [ Time Frame: at day 10, 21 and 28 relative to baseline ] [ Designated as safety issue: No ]
  • Change in KHQ [ Time Frame: at day 10, 21 and 28 relative to baseline ] [ Designated as safety issue: No ]

Enrollment: 386
Study Start Date: October 2009
Study Completion Date: October 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cystitis
female with cystitis symptoms
Drug: Ciprobay
Ciprobay (250mg, bid, oral)

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Outpatient

Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01631955

Locations
Korea, Republic of
Soonchunhyang University Bucheon Hospital
Bucheon, Gyeonggi-do, Korea, Republic of, 420-767
Sponsors and Collaborators
Soonchunhyang University Hospital
Investigators
Principal Investigator: Min-Eui Kim, MD, PhD Soonchunhyang University Hospital
  More Information

No publications provided

Responsible Party: Kwang-Woo Lee, MD, Department of urology, Soonchunhyang University Hospital
ClinicalTrials.gov Identifier: NCT01631955     History of Changes
Other Study ID Numbers: KAUTII&Schbc-UTI-QoL
Study First Received: June 27, 2012
Last Updated: June 28, 2012
Health Authority: South Korea: Institutional Review Board

Keywords provided by Soonchunhyang University Hospital:
Acute cystitis
Antibiotics
Quality of life

Additional relevant MeSH terms:
Cystitis
Acute Disease
Urinary Bladder Diseases
Urologic Diseases
Disease Attributes
Pathologic Processes
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on August 19, 2014