Acute CystitisNCT01631955
Assessment of UTI Symptoms and Quality of Life According to Antibiotics Treatment in Acute Uncomplicated Cystitis
An observational study of Acute Cystitis, run by Soonchunhyang University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years, women only
- Conditions the study is for
- Acute Cystitis
- What is being tested?
- Ciprobay
- Type of treatment
- Pill or oral medicine
- How many people
- 386 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2009to Oct 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Outpatient
Who may be able to join
- Female outpatients (20-65 years old)
- Acute cystitis symptoms (subject-reported) for < 1 week prior to Visit 1.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Soonchunhyang University Bucheon Hospital
Bucheon-si, Gyeonggi-do, 420-767
About this study
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
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
- Being tested
- Ciprobay
- Keywords
- Acute cystitis, Antibiotics, Quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CiprobayDrug
Ciprobay (250mg, bid, oral)
| Study group | Role | What they receive |
|---|---|---|
| Cystitis | female with cystitis symptoms Receives: Drug: Ciprobay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect on patient satisfaction and quality of life.
Measured: at day 5 relative to baseline
Secondary outcomes (2)
Change in UTISA sub-category (dysuria, frequency, urgency, pain, hematuria)
Measured: at day 10, 21 and 28 relative to baseline
Change in KHQ
Measured: at day 10, 21 and 28 relative to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2012 (estimated)
- Study startOct 2009
- Primary completionFeb 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute CystitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 386 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soonchunhyang University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kwang-Woo Lee, MD, Soonchunhyang University Hospital
- Investigators
- Min-Eui Kim, MD, PhD, Principal investigator, Soonchunhyang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01631955
- Sponsor's protocol ID
- KAUTII&Schbc-UTI-QoL
- Status last verified
- Jun 2012
- First submitted
- 27 Jun 2012
- Last updated
- 29 Jun 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01631955
- Acronym / sponsor ID
- KAUTII&Schbc-UTI-QoL
- Conditions
- Acute Cystitis
- Keywords
- Acute cystitis, Antibiotics, Quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 386 participants (actual)
- Lead sponsor
- Soonchunhyang University HospitalUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 29 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cystitis | – | Drug: Ciprobayfemale with cystitis symptoms |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatient
Key inclusion criteria (2 listed)
- Female outpatients (20-65 years old)
- Acute cystitis symptoms (subject-reported) for < 1 week prior to Visit 1.
Key exclusion criteria (14 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CiprobayCiprobay (250mg, bid, oral) | Drug | Cystitis |
Primary outcome
Effect on patient satisfaction and quality of life.
Time frame: at day 5 relative to baseline
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Min-Eui Kim, MD, PhD principal investigator
Soonchunhyang University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Cystitis, run by Soonchunhyang University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect on patient satisfaction and quality of life. (time frame: at day 5 relative to baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2012.