Overactive Bladder SyndromeNCT01559623
Colonization of the Female Urethra With Mycoplasma Hominis, Ureaplasma Urealyticum, Chlamydia Trachomatis, or Neisseria Gonorrhea in Patients With Lower Urinary Tract Symptoms
An observational study of Overactive Bladder Syndrome, run by University of Zurich at 1 site in Switzerland.
Trial summary
The purpose of this study is to assess the prevalence of mycoplasma hominis, ureaplasma urealyticum, neisseria gonorrhea, and chlamydia trachomatis in women with overactive bladder symptoms, and to correlate these findings with cystoscopic and urodynamic findings. Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Overactive Bladder Syndrome
- What is being tested?
- retrospective data analysis
- Type of treatment
- Surgery or procedure
- How many people
- 766 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2009to Feb 2013
- 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 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: clinic for urogynecology
Who may be able to join
- women with urogynecologic and urodynamic examination at our institution between 1.1.2009 and 31.12.2011
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Gynecology
Zurich, Canton of Zurich, 8091
About this study
The purpose of this study is to assess the prevalence of mycoplasma hominis, ureaplasma urealyticum, neisseria gonorrhea, and chlamydia trachomatis in women with overactive bladder symptoms, and to correlate these findings with cystoscopic and urodynamic findings.
- Conditions
- Overactive Bladder Syndrome
- Being tested
- retrospective data analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retrospective data analysisProcedure or surgery
retrospective data analysis
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of ureaplasma urealyticum
Measured: time of urogynecologic assessment
prevalence of mycoplasma hominis
Measured: time of urogynecologic assessment
prevalence of neisseria gonorrhea
Measured: time of urogynecologic assessment
prevalence of chlamydia trachomatis
Measured: time of urogynecologic assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2012 (estimated)
- Study startJan 2009
- Primary completionDec 2011
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive Bladder SyndromeStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- Time perspective
- Retrospective
- Enrolment
- 766 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Amos Scheiner, MD, Principal investigator, University Hospital Zurich, Division of Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01559623
- Sponsor's protocol ID
- OAB2012
- Status last verified
- Dec 2014
- First submitted
- 19 Mar 2012
- Last updated
- 16 Dec 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colonization of the Female Urethra With Mycoplasma Hominis, Ureaplasma Urealyticum, Chlamydia Trachomatis, or Neisseria Gonorrhea in Patients With Lower Urinary Tract Symptoms
- ClinicalTrials.gov ID
- NCT01559623
- Acronym / sponsor ID
- OAB2012
- Conditions
- Overactive Bladder Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 766 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 21 Mar 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.
The purpose of this study is to assess the prevalence of mycoplasma hominis, ureaplasma urealyticum, neisseria gonorrhea, and chlamydia trachomatis in women with overactive bladder symptoms, and to correlate these findings with cystoscopic and urodynamic findings.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- clinic for urogynecology
Key inclusion criteria (1 listed)
- women with urogynecologic and urodynamic examination at our institution between 1.1.2009 and 31.12.2011
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| retrospective data analysisretrospective data analysis | Procedure or surgery | – |
Primary outcome
prevalence of ureaplasma urealyticum
Time frame: time of urogynecologic assessment
prevalence of mycoplasma hominis
Time frame: time of urogynecologic assessment
prevalence of neisseria gonorrhea
Time frame: time of urogynecologic assessment
prevalence of chlamydia trachomatis
Time frame: time of urogynecologic assessment
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 16 Dec 2014.
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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.
David Amos Scheiner, MD principal investigator
University Hospital Zurich, Division of Gynecology
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 Overactive Bladder Syndrome, run by University of Zurich at 1 site in Switzerland.
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 1 inclusion and 1 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 16 Dec 2014. 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 Switzerland. 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?
prevalence of ureaplasma urealyticum (time frame: time of urogynecologic assessment). The study lists 4 primary outcomes in all. 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 16 Dec 2014.