Methenamine Hippurate Following Intradetrusor OnabotulinumtoxinA Injection
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Methenamine Hippurate, Typically prescribed oral antibiotic prophylaxis.
- Who it may be relevant to
- Registry conditions: Overactive Bladder (OAB), Urinary Tract Infection (Diagnosis). Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Drug Methenamine Hippurate
Drug: Methenamine hippurate 1 gram by mouth twice daily for three days. - Drug 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.
Primary outcome measures
- Acute Urinary Tract Infection [Time frame: Date of the BOTOX-A injection to 30 days after the procedure]
Secondary outcome measures (1)
- Medication Satisfaction [Time frame: Completed over the phone >30 days after BOTOX-A injection.]
Eligibility criteria
Inclusion criteria
- 18 years of age or older
- undergoing intradetrusor BOTOX-A injections in the office setting for overactive bladder
Exclusion criteria
- 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)
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Women & Infants Hospital — Providence
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. PMID 3544661
- 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. PMID 12174159
- 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. PMID 38329493
- 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. PMID 23076896
- 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. PMID 20590550
- 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. PMID 38032120
- 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. PMID 30074062
- 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. PMID 31441676
Identifiers
NCT: NCT06953271 · 2265134