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Completed

NCT Number: NCT01631955

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

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.

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Key information

Conditions

Acute Cystitis

Age range

20 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Soonchunhyang University Bucheon Hospital

Bucheon-si, Gyeonggi-do, 420-767, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ciprobay

Drug

Ciprobay (250mg, bid, oral)

Primary outcomes

  1. Effect on patient satisfaction and quality of life.

    Time frame: at day 5 relative to baseline

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Soonchunhyang University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jun 29, 2012
Registry last updated
Jun 29, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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