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

NCT01631955 | Completed

• 1 other identifier: KAUTII&Schbc-UTI-QoL
• Study Type: observational
• Target: 386
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Cystitis

Keywords

Acute cystitis; Antibiotics; Quality of life

Outcome Measures

Primary Outcomes (1)

• Effect on patient satisfaction and quality of life.

  at day 5 relative to baseline

Secondary Outcomes (2)

• Change in UTISA sub-category (dysuria, frequency, urgency, pain, hematuria)

  at day 10, 21 and 28 relative to baseline

• Change in KHQ

  at day 10, 21 and 28 relative to baseline

Study Arms (1)

Cystitis

female with cystitis symptoms

Drug: Ciprobay

Interventions

Ciprobay DRUG

Ciprobay (250mg, bid, oral)

Cystitis

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Outpatient

You may qualify if:

• Female outpatients (20-65 years old)
• Acute cystitis symptoms (subject-reported) for \< 1 week prior to Visit 1.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Soonchunhyang University Hospital: lead

Study Sites (1)

Soonchunhyang University Bucheon Hospital

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

Location

Study Officials

• Min-Eui Kim, MD, PhD

  Soonchunhyang University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of urology

Study Record Dates

• First Submitted: June 27, 2012
• First Posted: June 29, 2012
• Study Start: October 1, 2009
• Primary Completion: February 1, 2011
• Study Completion: October 1, 2011
• Last Updated: June 29, 2012

Record last verified: 2012-06

Locations

KR (1)