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

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ClinicalTrials.gov Identifier: NCT01631955
Recruitment Status : Completed
First Posted : June 29, 2012
Last Update Posted : June 29, 2012
Sponsor:
Information provided by (Responsible Party):
Kwang-Woo Lee, MD, Soonchunhyang University Hospital

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Acute Cystitis Drug: Ciprobay

Study Design
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Study Type : Observational
Actual Enrollment : 386 participants
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
Study Start Date : October 2009
Actual Primary Completion Date : February 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Groups and Cohorts
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Group/Cohort Intervention/treatment
Cystitis
female with cystitis symptoms
 Drug: Ciprobay
Ciprobay (250mg, bid, oral)


Outcome Measures
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Primary Outcome Measures :
  1. Effect on patient satisfaction and quality of life. [ Time Frame: at day 5 relative to baseline ]

Secondary Outcome Measures :
  1. Change in UTISA sub-category (dysuria, frequency, urgency, pain, hematuria) [ Time Frame: at day 10, 21 and 28 relative to baseline ]
  2. Change in KHQ [ Time Frame: at day 10, 21 and 28 relative to baseline ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes 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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01631955


Locations
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Korea, Republic of
Soonchunhyang University Bucheon Hospital
Bucheon, Gyeonggi-do, Korea, Republic of, 420-767
Sponsors and Collaborators
Soonchunhyang University Hospital
Investigators
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Principal Investigator: Min-Eui Kim, MD, PhD Soonchunhyang University Hospital
More Information
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Responsible Party: Kwang-Woo Lee, MD, Department of urology, Soonchunhyang University Hospital
ClinicalTrials.gov Identifier: NCT01631955    
Other Study ID Numbers: KAUTII&Schbc-UTI-QoL
First Posted: June 29, 2012    Key Record Dates
Last Update Posted: June 29, 2012
Last Verified: June 2012
Keywords provided by Kwang-Woo Lee, MD, Soonchunhyang University Hospital:
Acute cystitis
Antibiotics
Quality of life
Additional relevant MeSH terms:
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Cystitis
Urinary Bladder Diseases
Urologic Diseases