Methenamine Hippurate Following Intradetrusor OnabotulinumtoxinA Injection

NCT06953271 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: 2265134
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

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.

Conditions

Overactive Bladder (OAB); Urinary Tract Infection (Diagnosis)

Keywords

Overactive Bladder; onabotulinumtoxinA; Methenamine; Urinary Tract Infection; BOTOX-A; UTI; OAB

Outcome Measures

Primary Outcomes (1)

• 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.

  Date of the BOTOX-A injection to 30 days after the procedure

Secondary Outcomes (1)

• Medication Satisfaction

  Completed over the phone >30 days after BOTOX-A injection.

Study Arms (2)

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.

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.

Drug: Methenamine Hippurate

Interventions

Methenamine Hippurate DRUG

Drug: Methenamine hippurate 1 gram by mouth twice daily for three days.

Methenamine hippurate prophylaxis

Typically prescribed oral antibiotic prophylaxis DRUG

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.

Also known as: Oral antibiotics

Typically prescribed oral antibiotic prophylaxis

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• undergoing intradetrusor BOTOX-A injections in the office setting for overactive bladder

You may not qualify if:

• 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

Sponsors & Collaborators

• Women and Infants Hospital of Rhode Island: lead

Study Sites (1)

Women & Infants Hospital

Providence, Rhode Island, 02903, United States

Location

Related Publications (9)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 38032120 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 37938397 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Tract Infections; Disease

Interventions

methenamine hippurate; Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infections; Pathologic Processes

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Vivian Sung, MD, MPH

  Women & Infants Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Colin Russell, MD, MPH

CONTACT

401-453-7560; CoRussell@wihri.org

Kyle Wohlrab, MD

CONTACT

401-453-7560; KWohlrab@CareNE.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: May 1, 2025
• Study Start: May 15, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)