Overactive BladderNCT04479709
The Urinary Microbiome in Patients Receiving Intradetrusor Botox Injections
An observational study of Overactive Bladder, run by MetroHealth Medical Center at 1 site in United States.
Trial summary
An altered urinary microbiome (UM) may explain the symptoms in overactive bladder (OAB) patients who were previously considered to have "idiopathic" OAB. To date, most research on the relationship between OAB and the UM has focused on differentiating between the UM of a normal bladder and that of an OAB bladder. Read more about this study
- Who is it for?
- Ages 18 to 89 years, women only
- Conditions the study is for
- Overactive Bladder
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2021to 30 Jun 2022
- How long will I take part?
- 4 Weeks
- 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 89 years
- Women only
- Adult, Older adult
Study population: Women undergoing intradetrusor botox injection with botox 100 U
Who may be able to join
- Women undergoing intradetrusor botox injection with botox 100 U
Who cannot join
- Current UTI
- History of recurrent UTI
- History of antibiotic exposure for any reason (including if response is "unknown")
- Antibiotic exposure for any reason other than post-procedure prophylaxis during the four-week follow-up period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Urinary Microbiome Before and After Treatment With Intradetrusor Onabotulinum Toxin A Injection for Overactive Bladder
An altered urinary microbiome (UM) may explain the symptoms in overactive bladder (OAB) patients who were previously considered to have "idiopathic" OAB. To date, most research on the relationship between OAB and the UM has focused on differentiating between the UM of a normal bladder and that of an OAB bladder. There is currently a paucity of data on the way that OAB therapy impacts the UM. One of the few studies to evaluate the UM pre- and post-OAB treatment focused on how management with solifenacin affected the UM, but no studies have evaluated how intravesical onabotulinumtoxin A injections (IOI) affects the UM. Understanding IOI's impact on the UM is particularly interesting because despite both anticholinergics and IOI exerting antimuscarinic affects on the bladder, IOI is often successful when anticholinergics are not. This raises the question of what other mechanisms of action IOI may have in the bladders of OAB patients - one hypothesis is that it might stabilize the UM in those select patients who suffer from OAB due to an altered UM. The primary objective of this study is therefore to determine the UM profiles of OAB patients before and after treatment with IOI.
- Conditions
- Overactive Bladder
- Keywords
- Overactive bladder, Urinary microbiome
- Medical subject headings
- Urinary Bladder, Overactive
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary Microbiome
To evaluate whether administration of intradetrusor botox injections for the treatment of overactive bladder results in changes to the urinary microbiome.
Measured: 08/2020 - 08/2021
Secondary outcomes (3)
Urinary Microbiome by response
To evaluate whether there are differences between responders and non-responders to intradetrusor botox injections in the pre- and post-treatment urinary microbiomes.
Measured: 08/2020 - 08/2021
Urinary tract infection
Determine if there is a relationship between pre- or post-intradetrusor botox injection and the rate of urinary tract infection.
Measured: 08/2020 - 08/2021
Adverse events
Adverse events from intradetrusor botox injection
Measured: 08/2020 - 08/2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start1 Jan 2021
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 60 participants (actual)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- MetroHealth Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey Mangel, MetroHealth Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04479709
- Sponsor's protocol ID
- IRB20-00120
- Status last verified
- Feb 2024
- First submitted
- 16 Jul 2020
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Palm KM, Abrams MK, Sears SB, Wherley SD, Alfahmy AM, Kamumbu SA, Chakraborty NN, Mahajan ST, El-Nashar SA, Henderson JW, Hijaz AK, Mangel JM, Pollard RR, Al-Shakhshir H, Retuerto MA, Steller KM, Elshaer M, Ghannoum MA, Sheyn D. The Response of the Urinary Microbiome to Botox. Int Urogynecol J. 2024 Jan;35(1):237-251. doi: 10.1007/s00192-023-05703-1. Epub 2024 Jan 2.
PubMed 38165444
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Urinary Microbiome Before and After Treatment With Intradetrusor Onabotulinum Toxin A Injection for Overactive Bladder
- ClinicalTrials.gov ID
- NCT04479709
- Acronym / sponsor ID
- IRB20-00120
- Conditions
- Overactive Bladder
- Keywords
- Overactive bladder, Urinary microbiome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- MetroHealth Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 21 Jul 2020 (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.
An altered urinary microbiome (UM) may explain the symptoms in overactive bladder (OAB) patients who were previously considered to have "idiopathic" OAB. To date, most research on the relationship between OAB and the UM has focused on differentiating between the UM of a normal bladder and that of an OAB bladder. There is currently a paucity of data on the way that OAB therapy impacts the UM. One of the few studies to evaluate the UM pre- and post-OAB treatment focused on how management with solifenacin affected the UM, but no studies have evaluated how intravesical onabotulinumtoxin A injections (IOI) affects the UM. Understanding IOI's impact on the UM is particularly interesting because despite both anticholinergics and IOI exerting antimuscarinic affects on the bladder, IOI is often successful when anticholinergics are not. This raises the question of what other mechanisms of action IOI may have in the bladders of OAB patients - one hypothesis is that it might stabilize the UM in those select patients who suffer from OAB due to an altered UM. The primary objective of this study is therefore to determine the UM profiles of OAB patients before and after treatment with IOI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
Who may qualify
- Ages
- 18 to 89 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Women undergoing intradetrusor botox injection with botox 100 U
Key inclusion criteria (1 listed)
- Women undergoing intradetrusor botox injection with botox 100 U
Key exclusion criteria (4 listed)
- Current UTI
- History of recurrent UTI
- History of antibiotic exposure for any reason (including if response is "unknown")
- Antibiotic exposure for any reason other than post-procedure prophylaxis during the four-week follow-up period.
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 Microbiome
Time frame: 08/2020 - 08/2021
To evaluate whether administration of intradetrusor botox injections for the treatment of overactive bladder results in changes to the urinary microbiome.
3 secondary outcomes
Urinary Microbiome by response
Time frame: 08/2020 - 08/2021
Urinary tract infection
Time frame: 08/2020 - 08/2021
Adverse events
Time frame: 08/2020 - 08/2021
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 15 Feb 2024.
- Results publication: PubMed 38165444Palm KM, Abrams MK, Sears SB, Wherley SD, Alfahmy AM, Kamumbu SA, Chakraborty NN, Mahajan ST, El-Nashar SA, Henderson JW, Hijaz AK, Mangel JM, Pollard RR, Al-Shakhshir H, Retuerto MA, Steller KM, Elshaer M, Ghannoum MA, Sheyn D. The Response of the Urinary Microbiome to Botox. Int Urogynecol J. 2024 Jan;35(1):237-251. doi: 10.1007/s00192-023-05703-1. Epub 2024 Jan 2.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by MetroHealth Medical Center at 1 site 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 1 inclusion and 4 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 15 Feb 2024. 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 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 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?
Urinary Microbiome (time frame: 08/2020 - 08/2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04479709, which also lists 1 linked publication.
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 15 Feb 2024; AzTrials last refreshed its copy on 6 Nov 2026.