Methenamine Hippurate Following Intradetrusor OnabotulinumtoxinA Injection
NCT ID: NCT06953271
Last Updated: 2025-05-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
164 participants
INTERVENTIONAL
2025-05-15
2027-01-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Typically prescribed oral antibiotic prophylaxis
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.
Typically prescribed oral antibiotic prophylaxis
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.
Methenamine hippurate prophylaxis
Participants in the experimental arm will receive methenamine hippurate 1 gram by mouth twice daily for three days.
Methenamine Hippurate
Drug: Methenamine hippurate 1 gram by mouth twice daily for three days.
Interventions
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Methenamine Hippurate
Drug: Methenamine hippurate 1 gram by mouth twice daily for three days.
Typically prescribed oral antibiotic prophylaxis
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* undergoing intradetrusor BOTOX-A injections in the office setting for overactive bladder
Exclusion Criteria
* 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)
* 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
18 Years
FEMALE
No
Sponsors
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Women and Infants Hospital of Rhode Island
OTHER
Responsible Party
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Principal Investigators
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Vivian Sung, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Women & Infants Hospital
Locations
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Women & Infants Hospital
Providence, Rhode Island, United States
Countries
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Central Contacts
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References
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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.
Schiotz 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.
Davidson 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.
Lee 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.
Mouttalib 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.
Shapiro 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.
Houman 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.
Lightner 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.
Getaneh 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.
Other Identifiers
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2265134
Identifier Type: -
Identifier Source: org_study_id
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