Overactive BladderNCT04831801
OAB and the Microbiome
An observational study of Overactive Bladder and Urgency-frequency Syndrome, run by University of Miami at 2 sites in United States.
Trial summary
To determine differences in the urinary microbiomes, identified by polymerase change reaction (PCR) (UTIP™), of female patients with urgency and frequency syndrome with or without pelvic pain (Group A) compared to female controls without symptoms of lower urinary tract symptoms (LUTS) (Group B). Read more about this study
- Who is it for?
- Ages 18 to 90 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overactive Bladder, Urgency-frequency Syndrome
- How many people
- 39 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Jun 2021to 20 Nov 2023
- 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 to 90 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Female patients with OAB and controls will be enrolled from University of Miami's or Holy Cross Hospital's female pelvic medicine and reconstructive surgery clinics.
Who may be able to join
- 18 y/o-90 y/o
- Able to consent
- Group A only: Urgency and Frequency Syndrome or OAB only. UDI-6 answer of "moderately" to "quite a bit" on questions 1 or 2.
- Group B only: Urinary Distress Inventory 6 (UDI-6) answer "not at all" or "somewhat" for questions 1 or 2.
Who cannot join
- Pregnant
- Pelvic radiation
- Urinary retention (>200 ml)
- Renal calculi
- Recurrent urinary tract infection (UTI) (2 in 6 months), or
- Current UTI
- Immunosuppressed or radiation history
- Neurologic disorder
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Holy Cross Hospital
Fort Lauderdale, Florida, 33301
University of Miami
Miami, Florida, 33136
About this study
Official title: Trends in the Microbiome Profiles of Women With Urgency and Frequency Syndrome, With or Without Pelvic Pain?
To determine differences in the urinary microbiomes, identified by polymerase change reaction (PCR) (UTIP™), of female patients with urgency and frequency syndrome with or without pelvic pain (Group A) compared to female controls without symptoms of lower urinary tract symptoms (LUTS) (Group B).
- Conditions
- Overactive Bladder, Urgency-frequency Syndrome
- 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 |
|---|---|---|
| Female patients with overactive bladder (OAB) | Patients with urgency and frequency syndrome with or without pelvic pain (Group A) will provide two urine samples. One urine sample is a clean catch and the other is a catheterized specimen. Both will be sent for analysis. A perineal swab will also be collect and analyzed for each patient. | |
| Female control patients without LUTS | Patients without LUTS (Group B) will provide two urine samples. One urine sample is a clean catch and the other is a catheterized specimen. Both will be sent for analysis. A perineal swab will also be collect and analyzed for each patient. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with Lactobacillus in samples.
Evaluation of urine and perineal samples by PCR.
Measured: Day 1
Proportion of patients negative for repeat sequencing.
Evaluation of urine and perineal samples by PCR.
Measured: Day 1
Proportion of patients with change in UDI-6 score
UDI 6 question 1 and 2 has a total score from 0-6 with a high score indicating more distress. Proportion of patients with a decrease in score from baseline will be reported for this outcome.
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start30 Jun 2021
- Primary completion20 Nov 2023
- Study completion20 Nov 2023
Why it stopped: No longer with institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Martin, University of Miami
- Investigators
- Laura Martin, DO, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04831801
- Sponsor's protocol ID
- 20201001
- Status last verified
- May 2024
- First submitted
- 2 Apr 2021
- Last updated
- 21 May 2024
- 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 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trends in the Microbiome Profiles of Women With Urgency and Frequency Syndrome, With or Without Pelvic Pain?
- ClinicalTrials.gov ID
- NCT04831801
- Acronym / sponsor ID
- 20201001
- Conditions
- Overactive Bladder, Urgency-frequency Syndrome
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: No longer with institution
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 20 Nov 2023 (actual)
- Study completion
- 20 Nov 2023 (actual)
- First posted
- 5 Apr 2021 (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.
To determine differences in the urinary microbiomes, identified by polymerase change reaction (PCR) (UTIP™), of female patients with urgency and frequency syndrome with or without pelvic pain (Group A) compared to female controls without symptoms of lower urinary tract symptoms (LUTS) (Group B).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Female patients with overactive bladder (OAB) | – | –Patients with urgency and frequency syndrome with or without pelvic pain (Group A) will provide two urine samples. One urine sample is a clean catch and the other is a catheterized specimen. Both will be sent for analysis. A perineal swab will also be collect and analyzed for each patient. |
| Female control patients without LUTS | – | –Patients without LUTS (Group B) will provide two urine samples. One urine sample is a clean catch and the other is a catheterized specimen. Both will be sent for analysis. A perineal swab will also be collect and analyzed for each patient. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients with OAB and controls will be enrolled from University of Miami's or Holy Cross Hospital's female pelvic medicine and reconstructive surgery clinics.
Key inclusion criteria (4 listed)
- 18 y/o-90 y/o
- Able to consent
- Group A only: Urgency and Frequency Syndrome or OAB only. UDI-6 answer of "moderately" to "quite a bit" on questions 1 or 2.
- Group B only: Urinary Distress Inventory 6 (UDI-6) answer "not at all" or "somewhat" for questions 1 or 2.
Key exclusion criteria (8 listed)
- Pregnant
- Pelvic radiation
- Urinary retention (>200 ml)
- Renal calculi
- Recurrent urinary tract infection (UTI) (2 in 6 months), or
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
Proportion of patients with Lactobacillus in samples.
Time frame: Day 1
Evaluation of urine and perineal samples by PCR.
Proportion of patients negative for repeat sequencing.
Time frame: Day 1
Evaluation of urine and perineal samples by PCR.
Proportion of patients with change in UDI-6 score
Time frame: Up to 4 weeks
UDI 6 question 1 and 2 has a total score from 0-6 with a high score indicating more distress. Proportion of patients with a decrease in score from baseline will be reported for this outcome.
Results and safety
The study was stopped early (reason given: No longer with institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- 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.
Laura Martin, DO principal investigator
University of Miami
2 sites 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 and Urgency-frequency Syndrome, run by University of Miami at 2 sites in United States.
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 8 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: stopped early, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 was stopped early (reason given: No longer with institution). Results are not available in the source record.
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?
Proportion of patients with Lactobacillus in samples. (time frame: Day 1). The study lists 3 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 21 May 2024.