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
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Condition or disease | Intervention/treatment |
---|---|
Acute Cystitis | Drug: Ciprobay |
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 |
Group/Cohort | Intervention/treatment |
---|---|
Cystitis
female with cystitis symptoms
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Drug: Ciprobay
Ciprobay (250mg, bid, oral) |
- Effect on patient satisfaction and quality of life. [ Time Frame: at day 5 relative to baseline ]
- Change in UTISA sub-category (dysuria, frequency, urgency, pain, hematuria) [ Time Frame: at day 10, 21 and 28 relative to baseline ]
- Change in KHQ [ Time Frame: at day 10, 21 and 28 relative to baseline ]

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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 |
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.

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
Korea, Republic of | |
Soonchunhyang University Bucheon Hospital | |
Bucheon, Gyeonggi-do, Korea, Republic of, 420-767 |
Principal Investigator: | Min-Eui Kim, MD, PhD | Soonchunhyang University Hospital |
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 |
Acute cystitis Antibiotics Quality of life |
Cystitis Urinary Bladder Diseases Urologic Diseases |