MicrobiotaNCT05328011
Targeting Microbiota in Female Overactive Bladder Syndrome
An observational study of Microbiota and Urinary Bladder, Overactive, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The aim of this study is to compare the urinary viral microbiome and bacterial microbiome between overactive bladder syndrome (OAB) patients and healthy controls in order to determine a possible alteration in the urinary microbiome which may predispose women for OAB, and also in order to determine a possible influence… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Microbiota, Urinary Bladder, Overactive
- How many people
- 100 participants
- Where
- 1 siteAustria
- Study dates
- 1 Dec 2020to 30 Nov 2024
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients bothering for OAB, who present themselves at the urogynecological outpatient clinic, are considered to be eligible for inclusion in this study.
Who may be able to join
- symptoms of overactive bladder (urgency with or without urinary leakage, usually with frequency and nocturia)
- without symptoms of overactive bladder or any other form of lower urinary tract symptoms
- Age-matched to case group (+/- 5 years)
- BMI-matched to case group (18,5- 24,9 kg/m2 normal weight; 25- 29,9 kg/m2 overweight; 30- 34,9 kg/m2 obesity grade I)
Who cannot join
- Pregnant or lactating females
- Neurological conditions (such as MS, Parkinson, spinal cord injury, stroke..)
- Pelvic Organ Prolapse (stage ≥ 3)
- Lower Urinary Tract surgery within past 6 months
- Known history of interstitial cystitis or pain associated with OAB
- Recurrent urinary tract infections > 3/year
Show all 13Show fewer
- Acute urinary tract infection
- Urinary retention (with or without required self- catheterization)
- Stress urinary incontinence or mixed urinary incontinence
- Bladder cancer
- Renal insufficiency
- Urinary tract stones
- As case group plus any form of lower urinary tract symptoms including OAB
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, 1090
Marianne Koch, MD PhD, +4314040029150, marianne.koch@meduniwien.ac.at
About this study
The aim of this study is to compare the urinary viral microbiome and bacterial microbiome between overactive bladder syndrome (OAB) patients and healthy controls in order to determine a possible alteration in the urinary microbiome which may predispose women for OAB, and also in order to determine a possible influence of the urinary viral microbiome on the urinary bacterial microbiome which may predispose the individual to OAB. Furthermore, we aim to compare the urinary bacterial microbiome to the vaginal, rectal, urethral and salivary bacterial microbiome within the same individual and between the two groups in order to determine a possible route of colonization of the urinary bladder.
- Conditions
- Microbiota, Urinary Bladder, Overactive
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| overactive bladder syndrome | female patients with overactive bladder syndrome | |
| controls | women without overactive bladder syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
urinary bacterial and viral microbiome
Measured: 1 day
Secondary outcomes (1)
bacterial and viral microbiome of vagina, urethra, feces and oral cavity
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start1 Dec 2020
- Primary completion30 Nov 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MicrobiotaStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wolfgang Umek, MD, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05328011
- Sponsor's protocol ID
- 2160/2019
- Status last verified
- Mar 2022
- First submitted
- 7 Apr 2022
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Microbiota in Female Overactive Bladder Syndrome
- ClinicalTrials.gov ID
- NCT05328011
- Acronym / sponsor ID
- 2160/2019
- Conditions
- Microbiota, Urinary Bladder, Overactive
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 14 Apr 2022 (actual)
- 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 aim of this study is to compare the urinary viral microbiome and bacterial microbiome between overactive bladder syndrome (OAB) patients and healthy controls in order to determine a possible alteration in the urinary microbiome which may predispose women for OAB, and also in order to determine a possible influence of the urinary viral microbiome on the urinary bacterial microbiome which may predispose the individual to OAB. Furthermore, we aim to compare the urinary bacterial microbiome to the vaginal, rectal, urethral and salivary bacterial microbiome within the same individual and between the two groups in order to determine a possible route of colonization of the urinary bladder.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| overactive bladder syndrome | – | –female patients with overactive bladder syndrome |
| controls | – | –women without overactive bladder syndrome |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients bothering for OAB, who present themselves at the urogynecological outpatient clinic, are considered to be eligible for inclusion in this study.
Key inclusion criteria (4 listed)
- symptoms of overactive bladder (urgency with or without urinary leakage, usually with frequency and nocturia)
- without symptoms of overactive bladder or any other form of lower urinary tract symptoms
- Age-matched to case group (+/- 5 years)
- BMI-matched to case group (18,5- 24,9 kg/m2 normal weight; 25- 29,9 kg/m2 overweight; 30- 34,9 kg/m2 obesity grade I)
Key exclusion criteria (13 listed)
- Pregnant or lactating females
- As case group plus any form of lower urinary tract symptoms including OAB
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
urinary bacterial and viral microbiome
Time frame: 1 day
1 secondary outcome
bacterial and viral microbiome of vagina, urethra, feces and oral cavity
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
- Individual participant dataSharing planned: No
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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.
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 Microbiota and Urinary Bladder, Overactive, run by Medical University of Vienna at 1 site in Austria.
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 4 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 14 Apr 2022. 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 Austria. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marianne Koch, MD PhD (+4314040029150, marianne.koch@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
urinary bacterial and viral microbiome (time frame: 1 day). 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 14 Apr 2022.