Overactive Bladder (OAB)Phase 4METANCT06953271
Methenamine Hippurate Following Intradetrusor OnabotulinumtoxinA Injection
A Phase 4 study testing Methenamine Hippurate and Typically prescribed oral antibiotic prophylaxis in people with Overactive Bladder (OAB) and Urinary Tract Infection (Diagnosis), run by Women and Infants Hospital of Rhode Island at 1 site in United States.
Trial summary
The goal of this clinical trial is to compare methenamine hippurate prophylaxis to routine antibiotic prophylaxis following onabotulinumtoxinA (BOTOX-A) injections in women with overactive bladder (OAB). Participants will be randomly selected to receive one of the two post-procedural prophylaxis medications. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Overactive Bladder (OAB), Urinary Tract Infection (Diagnosis)
- What is being tested?
- Methenamine Hippurate and Typically prescribed oral antibiotic prophylaxis
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2025to 1 Apr 2027
- Phase
- Phase 4
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- undergoing intradetrusor BOTOX-A injections in the office setting for overactive bladder
Who cannot join
- cisgender male individuals
- neurogenic reasons for bladder symptoms (i.e. spinal cord injury, multiple sclerosis, etc.)
- known allergy and/or contraindication to methenamine hippurate
- currently already taking methenamine hippurate at the time of the procedure
- taking antibiotics for any reason on the day of their BOTOX-A procedure
- positive UTI at time of procedure (positive dip at time of procedure)
Show all 12Show fewer
- history of bladder cancer
- history of pelvic radiation
- surgically altered detrusor muscle
- pre-procedural need for catheterization
- diagnosis of Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS)
- pregnant or lactating individuals
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
Women & Infants Hospital
Providence, Rhode Island, 02903
Colin Russell, MD, MPH, 401-453-7560, CoRussell@wihri.org
Vivian Sung, MD, MPH
About this study
Official title: Methenamine Hippurate Compared to Typical Antibiotic Prophylaxis in the Prevention of Urinary Tract Infection Following Intradetrusor OnabotulinumtoxinA Injection for Treatment of Overactive Bladder: a Randomized Controlled Non-Inferiority Trial
The goal of this clinical trial is to compare methenamine hippurate prophylaxis to routine antibiotic prophylaxis following onabotulinumtoxinA (BOTOX-A) injections in women with overactive bladder (OAB). Participants will be randomly selected to receive one of the two post-procedural prophylaxis medications. The primary outcome measure will be urinary tract infection (UTI) rates within 30 days from the BOTOX-A procedure. Secondary outcomes will assess patient satisfaction with the two post-procedural prophylaxis medications.
Read the detailed description
The purpose of this randomized controlled non-inferiority study is to determine if methenamine hippurate is non-inferior in regards to UTI rate when compared to routinely prescribed antibiotic prophylaxis following intradetrusor BOTOX-A injections for women with OAB. As a secondary aim, this study will also compare patient medication satisfaction, as measured by the Functional Assessment of Chronic Illness Therapy-Treatment Satisfaction-General (FACIT-TS-G) for the two prophylactic medication arms.
Comparators: Methenamine hippurate versus routinely prescribed antibiotic prophylaxis Methenamine hippurate is an oral non-antibiotic antiseptic medication widely used in the prevention of recurrent UTIs.
164 women will be randomly assigned to each treatment option: 82 to methenamine hippurate and 82 to routinely prescribed antibiotic prophylaxis. The primary outcome of UTI rates within 30 days of the BOTOX-A procedure will be calculated for each study arm. The FACIT-TS-G will be administered to participants at the conclusion of the 30-day period.
- Being tested
- Methenamine Hippurate, Typically prescribed oral antibiotic prophylaxis
- Keywords
- Overactive Bladder, onabotulinumtoxinA, Methenamine, Urinary Tract Infection, BOTOX-A, UTI, OAB
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Tract Infections, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methenamine HippurateDrug
Drug: Methenamine hippurate 1 gram by mouth twice daily for three days.
Typically prescribed oral antibiotic prophylaxisDrug
Also called Oral antibiotics
Drug: typically prescribed oral antibiotic prophylaxis following intradetrusor BOTOX-A injections. This includes, but is not limited to, antibiotic medications such as nitrofurantoin, amoxicillin/clavulanic acid, and trimethoprim/sulfamethoxazole. Dosage will be determined per usual care. Duration of treatment will be standardized to three days.
| Study group | Role | What they receive |
|---|---|---|
| Typically prescribed oral antibiotic prophylaxis | Active comparator | Typically prescribed oral antibiotic prophylaxis for the purposes of this study is defined as oral antibiotics that are routinely prescribed following BOTOX-A injections for UTI prophylaxis. Given known heterogeneity in antibiotic prophylaxis type and duration as well as the lack of standardized antibiotic recommendations for intradetrusor BOTOX-A injections, the choice of antibiotic prophylaxis is deferred to the physician performing the BOTOX-A injections. The duration of treatment will be standardized to three days, based off previous studies. Receives: Drug: Typically prescribed oral antibiotic prophylaxis |
| Methenamine hippurate prophylaxis | Experimental | Participants in the experimental arm will receive methenamine hippurate 1 gram by mouth twice daily for three days. Receives: Drug: Methenamine Hippurate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Urinary Tract Infection
Presence of a urinary tract infection (UTI) within 30 days from intradetrusor BOTOX-A injection. UTI will be defined as positive lower urinary tract symptoms (dysuria, hematuria, and/or worsened urinary urgency or frequency) and a positive urine culture.
Measured: Date of the BOTOX-A injection to 30 days after the procedure
Secondary outcomes (1)
Medication Satisfaction
We will administer the validated Functional Assessment of Chronic Illness Therapy - Treatment Satisfaction - General (FACIT-TS-G Version 4) survey assessing medication-related (i.e. typical antibiotic or methenamine hippurate) satisfaction and perceived adverse events over the phone >30 days after intradetrusor BOTOX-A injection. The submission of the survey marks the conclusion of the participant's participation in the study.
Measured: Completed over the phone >30 days after BOTOX-A injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start1 Aug 2025
- Primary completion30 Jan 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women and Infants Hospital of Rhode Island
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vivian Sung, MD, MPH, Principal investigator, Women & Infants Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06953271
- Sponsor's protocol ID
- 2265134
- Acronym
- META
- Status last verified
- Aug 2025
- First submitted
- 23 Apr 2025
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tyreman NO, Andersson PO, Kroon L, Orstam S. Urinary tract infection after vaginal surgery. Effect of prophylactic treatment with methenamine hippurate. Acta Obstet Gynecol Scand. 1986;65(7):731-3. doi: 10.3109/00016348609161491.
PubMed 3544661Schiotz HA, Guttu K. Value of urinary prophylaxis with methenamine in gynecologic surgery. Acta Obstet Gynecol Scand. 2002 Aug;81(8):743-6. doi: 10.1080/j.1600-0412.2002.810810.x.
PubMed 12174159Davidson SM, Brown JN, Nance CB, Townsend ML. Use of Methenamine for Urinary Tract Infection Prophylaxis: Systematic Review of Recent Evidence. Int Urogynecol J. 2024 Mar;35(3):483-489. doi: 10.1007/s00192-024-05726-2. Epub 2024 Feb 8.
PubMed 38329493Lee BS, Bhuta T, Simpson JM, Craig JC. Methenamine hippurate for preventing urinary tract infections. Cochrane Database Syst Rev. 2012 Oct 17;10(10):CD003265. doi: 10.1002/14651858.CD003265.pub3.
PubMed 23076896Mouttalib S, Khan S, Castel-Lacanal E, Guillotreau J, De Boissezon X, Malavaud B, Marque P, Rischmann P, Game X. Risk of urinary tract infection after detrusor botulinum toxin A injections for refractory neurogenic detrusor overactivity in patients with no antibiotic treatment. BJU Int. 2010 Dec;106(11):1677-80. doi: 10.1111/j.1464-410X.2010.09435.x.
PubMed 20590550Shapiro K, Anger J, Cameron AP, Chung D, Daignault-Newton S, Ippolito GM, Lee U, Mourtzinos A, Padmanabhan P, Smith AL, Suskind AM, Tenggardjaja C, Van Til M, Brucker BM. Antibiotic use, best practice statement adherence, and UTI rate for intradetrusor onabotulinumtoxin-A injection for overactive bladder: A multi-institutional collaboration from the SUFU Research Network (SURN). Neurourol Urodyn. 2024 Feb;43(2):407-414. doi: 10.1002/nau.25334. Epub 2023 Nov 30.
PubMed 38032120Houman J, Moradzadeh A, Patel DN, Asanad K, Anger JT, Eilber KS. What is the ideal antibiotic prophylaxis for intravesically administered Botox injection? A comparison of two different regimens. Int Urogynecol J. 2019 May;30(5):701-704. doi: 10.1007/s00192-018-3721-4. Epub 2018 Aug 3.
PubMed 30074062Lightner DJ, Wymer K, Sanchez J, Kavoussi L. Best Practice Statement on Urologic Procedures and Antimicrobial Prophylaxis. J Urol. 2020 Feb;203(2):351-356. doi: 10.1097/JU.0000000000000509. Epub 2019 Aug 23.
PubMed 31441676Getaneh FW, Simhal R, Sholklapper T, Melvin E, Dorris CS, Chou J, Richter LA, Dieter A. Antibiotic prophylaxis for onabotulinum toxin A injections: systematic review and meta-analysis. Int Urogynecol J. 2024 Jan;35(1):19-29. doi: 10.1007/s00192-023-05665-4. Epub 2023 Nov 8.
PubMed 37938397
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methenamine Hippurate Compared to Typical Antibiotic Prophylaxis in the Prevention of Urinary Tract Infection Following Intradetrusor OnabotulinumtoxinA Injection for Treatment of Overactive Bladder: a Randomized Controlled Non-Inferiority Trial
- ClinicalTrials.gov ID
- NCT06953271
- Acronym / sponsor ID
- META / 2265134
- Keywords
- Overactive Bladder, onabotulinumtoxinA, Methenamine, Urinary Tract Infection, BOTOX-A, UTI, OAB
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Women and Infants Hospital of Rhode IslandUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 1 May 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.
The goal of this clinical trial is to compare methenamine hippurate prophylaxis to routine antibiotic prophylaxis following onabotulinumtoxinA (BOTOX-A) injections in women with overactive bladder (OAB). Participants will be randomly selected to receive one of the two post-procedural prophylaxis medications. The primary outcome measure will be urinary tract infection (UTI) rates within 30 days from the BOTOX-A procedure. Secondary outcomes will assess patient satisfaction with the two post-procedural prophylaxis medications.
Detailed description
The purpose of this randomized controlled non-inferiority study is to determine if methenamine hippurate is non-inferior in regards to UTI rate when compared to routinely prescribed antibiotic prophylaxis following intradetrusor BOTOX-A injections for women with OAB. As a secondary aim, this study will also compare patient medication satisfaction, as measured by the Functional Assessment of Chronic Illness Therapy-Treatment Satisfaction-General (FACIT-TS-G) for the two prophylactic medication arms.
Comparators: Methenamine hippurate versus routinely prescribed antibiotic prophylaxis Methenamine hippurate is an oral non-antibiotic antiseptic medication widely used in the prevention of recurrent UTIs.
164 women will be randomly assigned to each treatment option: 82 to methenamine hippurate and 82 to routinely prescribed antibiotic prophylaxis. The primary outcome of UTI rates within 30 days of the BOTOX-A procedure will be calculated for each study arm. The FACIT-TS-G will be administered to participants at the conclusion of the 30-day period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Typically prescribed oral antibiotic prophylaxis | Active comparator | Drug: Typically prescribed oral antibiotic prophylaxisTypically prescribed oral antibiotic prophylaxis for the purposes of this study is defined as oral antibiotics that are routinely prescribed following BOTOX-A injections for UTI prophylaxis. Given known heterogeneity in antibiotic prophylaxis type and duration as well as the lack of standardized antibiotic recommendations for intradetrusor BOTOX-A injections, the choice of antibiotic prophylaxis is deferred to the physician performing the BOTOX-A injections. The duration of treatment will be standardized to three days, based off previous studies. |
| Methenamine hippurate prophylaxis | Experimental | Drug: Methenamine HippurateParticipants in the experimental arm will receive methenamine hippurate 1 gram by mouth twice daily for three days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years of age or older
- undergoing intradetrusor BOTOX-A injections in the office setting for overactive bladder
Key exclusion criteria (12 listed)
- cisgender male individuals
- neurogenic reasons for bladder symptoms (i.e. spinal cord injury, multiple sclerosis, etc.)
- known allergy and/or contraindication to methenamine hippurate
- currently already taking methenamine hippurate at the time of the procedure
- taking antibiotics for any reason on the day of their BOTOX-A procedure
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 |
|---|---|---|
| Methenamine HippurateDrug: Methenamine hippurate 1 gram by mouth twice daily for three days. | Drug | Methenamine hippurate prophylaxis |
| Typically prescribed oral antibiotic prophylaxisAlso: Oral antibioticsDrug: typically prescribed oral antibiotic prophylaxis following intradetrusor BOTOX-A injections. This includes, but is not limited to, antibiotic medications such as nitrofurantoin, amoxicillin/clavulanic acid, and trimethoprim/sulfamethoxazole. Dosage will be determined per usual care. Duration of treatment will be standardized to three days. | Drug | Typically prescribed oral antibiotic prophylaxis |
Primary outcome
Acute Urinary Tract Infection
Time frame: Date of the BOTOX-A injection to 30 days after the procedure
Presence of a urinary tract infection (UTI) within 30 days from intradetrusor BOTOX-A injection. UTI will be defined as positive lower urinary tract symptoms (dysuria, hematuria, and/or worsened urinary urgency or frequency) and a positive urine culture.
1 secondary outcome
Medication Satisfaction
Time frame: Completed over the phone >30 days after BOTOX-A injection.
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 19 Aug 2026.
- Background: PubMed 3544661Tyreman NO, Andersson PO, Kroon L, Orstam S. Urinary tract infection after vaginal surgery. Effect of prophylactic treatment with methenamine hippurate. Acta Obstet Gynecol Scand. 1986;65(7):731-3. doi: 10.3109/00016348609161491.
- Background: PubMed 12174159Schiotz HA, Guttu K. Value of urinary prophylaxis with methenamine in gynecologic surgery. Acta Obstet Gynecol Scand. 2002 Aug;81(8):743-6. doi: 10.1080/j.1600-0412.2002.810810.x.
- Background: PubMed 38329493Davidson SM, Brown JN, Nance CB, Townsend ML. Use of Methenamine for Urinary Tract Infection Prophylaxis: Systematic Review of Recent Evidence. Int Urogynecol J. 2024 Mar;35(3):483-489. doi: 10.1007/s00192-024-05726-2. Epub 2024 Feb 8.
- Background: PubMed 23076896Lee BS, Bhuta T, Simpson JM, Craig JC. Methenamine hippurate for preventing urinary tract infections. Cochrane Database Syst Rev. 2012 Oct 17;10(10):CD003265. doi: 10.1002/14651858.CD003265.pub3.
- Background: PubMed 20590550Mouttalib S, Khan S, Castel-Lacanal E, Guillotreau J, De Boissezon X, Malavaud B, Marque P, Rischmann P, Game X. Risk of urinary tract infection after detrusor botulinum toxin A injections for refractory neurogenic detrusor overactivity in patients with no antibiotic treatment. BJU Int. 2010 Dec;106(11):1677-80. doi: 10.1111/j.1464-410X.2010.09435.x.
- Background: PubMed 38032120Shapiro K, Anger J, Cameron AP, Chung D, Daignault-Newton S, Ippolito GM, Lee U, Mourtzinos A, Padmanabhan P, Smith AL, Suskind AM, Tenggardjaja C, Van Til M, Brucker BM. Antibiotic use, best practice statement adherence, and UTI rate for intradetrusor onabotulinumtoxin-A injection for overactive bladder: A multi-institutional collaboration from the SUFU Research Network (SURN). Neurourol Urodyn. 2024 Feb;43(2):407-414. doi: 10.1002/nau.25334. Epub 2023 Nov 30.
- Background: PubMed 30074062Houman J, Moradzadeh A, Patel DN, Asanad K, Anger JT, Eilber KS. What is the ideal antibiotic prophylaxis for intravesically administered Botox injection? A comparison of two different regimens. Int Urogynecol J. 2019 May;30(5):701-704. doi: 10.1007/s00192-018-3721-4. Epub 2018 Aug 3.
- Background: PubMed 31441676Lightner DJ, Wymer K, Sanchez J, Kavoussi L. Best Practice Statement on Urologic Procedures and Antimicrobial Prophylaxis. J Urol. 2020 Feb;203(2):351-356. doi: 10.1097/JU.0000000000000509. Epub 2019 Aug 23.
- Background: PubMed 37938397Getaneh FW, Simhal R, Sholklapper T, Melvin E, Dorris CS, Chou J, Richter LA, Dieter A. Antibiotic prophylaxis for onabotulinum toxin A injections: systematic review and meta-analysis. Int Urogynecol J. 2024 Jan;35(1):19-29. doi: 10.1007/s00192-023-05665-4. Epub 2023 Nov 8.
- 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.
Vivian Sung, MD, MPH principal investigator
Women & Infants Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methenamine Hippurate and Typically prescribed oral antibiotic prophylaxis in people with Overactive Bladder (OAB) and Urinary Tract Infection (Diagnosis), run by Women and Infants Hospital of Rhode Island 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 2 inclusion and 12 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 19 Aug 2026. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Colin Russell, MD, MPH (401-453-7560, CoRussell@wihri.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Urinary Tract Infection (time frame: Date of the BOTOX-A injection to 30 days after the procedure). 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 NCT06953271, which also lists 9 linked publications.
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 19 Aug 2026.