Clinical trial NCT06953271: Methenamine Hippurate Following Intradetrusor OnabotulinumtoxinA Injection
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Overactive Bladder (OAB)
Urinary Tract Infection (Diagnosis)
Keywords: Overactive Bladder
onabotulinumtoxinA
Methenamine
Urinary Tract Infection
BOTOX-A
UTI
OAB
Lead sponsor: Women and Infants Hospital of Rhode Island
Sponsor class: OTHER
First posted: 2025-05-01
Enrollment: 164
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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.

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

Primary outcomes:
measure: Acute Urinary Tract Infection
timeFrame: Date of the BOTOX-A injection to 30 days after the procedure
Secondary outcomes:
measure: Medication Satisfaction
timeFrame: Completed over the phone >30 days after BOTOX-A injection.
Other outcomes:
Locations:
city: Providence
country: United States
facility: Women & Infants Hospital
state: Rhode Island
Study officials:
affiliation: Women & Infants Hospital
name: Vivian Sung, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.