Overactive Bladder (OAB)MICROAB_PilotNCT07025044
Assessing the Genitourinary Microbiome of Women With Overactive Bladder Undergoing Onabotulinum Toxin Type A Intradetrusor Injections
An observational study of Overactive Bladder (OAB) and Urge Incontinence, run by Alexis Dieter at 1 site in United States.
Trial summary
Single-site prospective observational pilot feasibility study of women with overactive bladder/urge urinary incontinence undergoing onabotulinum toxin type A intradetrusor injections in order to achieve the following objectives: Establish a record of successful collaboration with Dr. Read more about this study
- Who is it for?
- Ages 55 years and older, women only
- Conditions the study is for
- Overactive Bladder (OAB), Urge Incontinence
- What is being tested?
- onabotulinum toxin type a
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2025to 1 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 55 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Subjects from the patient population treated at a MedStar Urogynecology clinics located across DC, Maryland and Virginia will be recruited and eligible for enrollment. Potential subjects will be identified both via provider referral and through electronic medical record review to identify patients scheduled for onabotulinum toxin type A injection.
Who may be able to join
- Natal female > 55 years old
- English-speaking
- Scheduled to undergo onabotulinum toxin type A for treatment of OAB
- No menses for >1 year if uterus in situ
- Planning one dose nitrofurantoin for antibiotic prophylaxis at time of onabotulinum toxin type A injection per clinic protocol
Who cannot join
- Diagnosis of painful bladder syndrome
- Current symptomatic or clinically-suspected UTI within 30 days prior to onabotulinum toxin type A injection procedure*
- Systemic antibiotic exposure within 30 days^
- Prophylactic antibiotic treatment for recurrent UTI within the last 12 months
- Current systemic immunosuppressive therapy (i.e. prednisone or immunomodulators) immunotherapy, chemotherapy or radiation treatment
- Prior pelvic radiation
- Indwelling catheter or intermittent catheterization
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MedStar Urogynecology Clinic
Washington D.C., District of Columbia, 20010
Moriarty, 202-748-4112, Patricia.L.Moriarty@medstar.net
alexis.a.dieter@medstar.net
About this study
Official title: Characterizing the Postmenopausal Genitourinary Microbiome in Women Undergoing Onabotulinum Toxin Type A for Overactive Bladder - A Feasibility Trial
Single-site prospective observational pilot feasibility study of women with overactive bladder/urge urinary incontinence undergoing onabotulinum toxin type A intradetrusor injections in order to achieve the following objectives:
- Establish a record of successful collaboration with Dr. Ravel, an expert researcher in the female microbiome based at the University of Maryland
- Demonstrate the investigators' ability to recruit subjects from the diverse population of postmenopausal women undergoing BTX for OAB within MedStar Health Urogynecology clinics
- Collect, process and analyze urine specimens collected prior to and 4-weeks after BTX injection, and to compare the GU microbiome of self-collected versus clinic-collected samples
- Assess response to BTX treatment and explore rates of and risk factors for urinary tract infection and incomplete voiding requiring catheterization within the first 4-weeks after BTX
Read the detailed description
Participants will be recruited from MedStar Urogynecology clinics. English-speaking postmenopausal natal female > 55 years old scheduled to undergo BTX for treatment of overactive bladder (OAB) will be eligible for enrollment.
All subjects will be scheduled to undergo Onabotulinum toxin type A intradetrusor injection for management of OAB. On Day 0, subjects will undergo BTX injection by a licensed clinical provider and receive a one-time dose of Nitrofurantoin for infection prevention per standard clinic protocol. Per standard clinic protocol, all patients undergoing BTX receive a one-time dose of oral nitrofurantoin for infection prevention unless they have allergy/contraindication to nitrofurantoin or they are at high risk of UTI (3 or more culture-proven UTIs in the past year). BTX dose, any prior BTX treatments and time since last BTX injection will be recorded.
Voided urine specimens will be collected at the baseline and follow-up visits. Each subject will be asked to complete one self-collection and one clinic-collection at each time point for a total of four collections over the course of the study
Sample size is 40 subjects in this pilot feasibility study. Subjects will be followed for approximately 1 month after BTX injection. Self-collected and clinic-collected urine specimens will be obtained at baseline and 4 weeks after BTX injection. Subjects will also complete baseline questionnaires and validated patient reported outcome measures at baseline and 4 weeks follow-up. Subjects will be provided reimbursement for parking costs ($17/visit) for the procedure visit and for the follow-up visit. Subjects will be provided a payment of $50 upon completion of the follow-up visit activities.
- Conditions
- Overactive Bladder (OAB), Urge Incontinence
- Being tested
- onabotulinum toxin type a
- Keywords
- onabotulinum toxin type A
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
onabotulinum toxin type aDrug
Also called Botox, BTX
All subjects will be scheduled to undergo Onabotulinum toxin type A intradetrusor injection for management of OAB. On Day 0, subjects will undergo Onabotulinum toxin type A injection by a licensed clinical provider and receive a one-time dose of Nitrofurantoin for infection prevention per standard clinic protocol.
| Study group | Role | What they receive |
|---|---|---|
| Women >55yo undergoing onabotulinum toxin type A injection for OAB in clinic | Not described Receives: Drug: onabotulinum toxin type a |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
recruitment of 40 eligible subjects from our diverse population of postmenopausal women undergoing BTX for OAB
Measured: 6 months
Secondary outcomes (3)
Urine sample collection and comparison
To collect, process and analyze urine specimens collected prior to and 4-weeks after BTX injection, and to compare the GU microbiome of self-collected versus clinic-collected samples
Measured: 4 weeks
Onabotulinum toxin type A response
To assess response to Onabotulinum toxin type A treatment 4-weeks after Onabotulinum toxin type A
Measured: 4 weeks
Onabotulinum toxin type A adverse events
To explore rates of and risk factors for UTI and incomplete voiding requiring catheterization within the first 4-weeks after Onabotulinum toxin type A injection
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start3 Sep 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive Bladder (OAB)Studies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexis Dieter
- Sponsor type
- University, hospital or other
- Collaborators
- Medstar Health Research Institute
- Responsible party
- Sponsor-investigator, Alexis Dieter, MedStar Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07025044
- Sponsor's protocol ID
- STUDY00009131
- Acronym
- MICROAB_Pilot
- Status last verified
- Sep 2025
- First submitted
- 2 Jun 2025
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing the Postmenopausal Genitourinary Microbiome in Women Undergoing Onabotulinum Toxin Type A for Overactive Bladder - A Feasibility Trial
- ClinicalTrials.gov ID
- NCT07025044
- Acronym / sponsor ID
- MICROAB_Pilot / STUDY00009131
- Conditions
- Overactive Bladder (OAB), Urge Incontinence
- Keywords
- onabotulinum toxin type A
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Alexis DieterUniversity, hospital or other
- Collaborators
- Medstar Health Research Institute
- Study start
- 3 Sep 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 17 Jun 2025 (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.
Single-site prospective observational pilot feasibility study of women with overactive bladder/urge urinary incontinence undergoing onabotulinum toxin type A intradetrusor injections in order to achieve the following objectives:
- Establish a record of successful collaboration with Dr. Ravel, an expert researcher in the female microbiome based at the University of Maryland
- Demonstrate the investigators' ability to recruit subjects from the diverse population of postmenopausal women undergoing BTX for OAB within MedStar Health Urogynecology clinics
- Collect, process and analyze urine specimens collected prior to and 4-weeks after BTX injection, and to compare the GU microbiome of self-collected versus clinic-collected samples
- Assess response to BTX treatment and explore rates of and risk factors for urinary tract infection and incomplete voiding requiring catheterization within the first 4-weeks after BTX
Detailed description
Participants will be recruited from MedStar Urogynecology clinics. English-speaking postmenopausal natal female > 55 years old scheduled to undergo BTX for treatment of overactive bladder (OAB) will be eligible for enrollment.
All subjects will be scheduled to undergo Onabotulinum toxin type A intradetrusor injection for management of OAB. On Day 0, subjects will undergo BTX injection by a licensed clinical provider and receive a one-time dose of Nitrofurantoin for infection prevention per standard clinic protocol. Per standard clinic protocol, all patients undergoing BTX receive a one-time dose of oral nitrofurantoin for infection prevention unless they have allergy/contraindication to nitrofurantoin or they are at high risk of UTI (3 or more culture-proven UTIs in the past year). BTX dose, any prior BTX treatments and time since last BTX injection will be recorded.
Voided urine specimens will be collected at the baseline and follow-up visits. Each subject will be asked to complete one self-collection and one clinic-collection at each time point for a total of four collections over the course of the study
Sample size is 40 subjects in this pilot feasibility study. Subjects will be followed for approximately 1 month after BTX injection. Self-collected and clinic-collected urine specimens will be obtained at baseline and 4 weeks after BTX injection. Subjects will also complete baseline questionnaires and validated patient reported outcome measures at baseline and 4 weeks follow-up. Subjects will be provided reimbursement for parking costs ($17/visit) for the procedure visit and for the follow-up visit. Subjects will be provided a payment of $50 upon completion of the follow-up visit activities.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women >55yo undergoing onabotulinum toxin type A injection for OAB in clinic | – | Drug: onabotulinum toxin type a |
Who may qualify
- Ages
- 55 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects from the patient population treated at a MedStar Urogynecology clinics located across DC, Maryland and Virginia will be recruited and eligible for enrollment. Potential subjects will be identified both via provider referral and through electronic medical record review to identify patients scheduled for onabotulinum toxin type A injection.
Key inclusion criteria (5 listed)
- Natal female > 55 years old
- English-speaking
- Scheduled to undergo onabotulinum toxin type A for treatment of OAB
- No menses for >1 year if uterus in situ
- Planning one dose nitrofurantoin for antibiotic prophylaxis at time of onabotulinum toxin type A injection per clinic protocol
Key exclusion criteria (7 listed)
- Diagnosis of painful bladder syndrome
- Current symptomatic or clinically-suspected UTI within 30 days prior to onabotulinum toxin type A injection procedure*
- Systemic antibiotic exposure within 30 days^
- Prophylactic antibiotic treatment for recurrent UTI within the last 12 months
- Current systemic immunosuppressive therapy (i.e. prednisone or immunomodulators) immunotherapy, chemotherapy or radiation treatment
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 |
|---|---|---|
| onabotulinum toxin type aAlso: Botox, BTXAll subjects will be scheduled to undergo Onabotulinum toxin type A intradetrusor injection for management of OAB. On Day 0, subjects will undergo Onabotulinum toxin type A injection by a licensed clinical provider and receive a one-time dose of Nitrofurantoin for infection prevention per standard clinic protocol. | Drug | Women >55yo undergoing onabotulinum toxin type A injection for OAB in clinic |
Primary outcome
Recruitment
Time frame: 6 months
recruitment of 40 eligible subjects from our diverse population of postmenopausal women undergoing BTX for OAB
3 secondary outcomes
Urine sample collection and comparison
Time frame: 4 weeks
Onabotulinum toxin type A response
Time frame: 4 weeks
Onabotulinum toxin type A adverse events
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- 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.
MedStar Urogynecology Clinic
Washington D.C., United States
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 (OAB) and Urge Incontinence, run by Alexis Dieter 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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 12 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment (time frame: 6 months). 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 12 Sep 2025.