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NCT Number: NCT06953271

Methenamine Hippurate Following Intradetrusor OnabotulinumtoxinA Injection

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Methenamine Hippurate

Drug

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

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.

Other names: Oral antibiotics

Primary outcomes

  1. 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.

Secondary outcomes

  1. Medication Satisfaction

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Colin Russell, MD, MPH

CONTACT

[email protected]

401-453-7560

Kyle Wohlrab, MD

CONTACT

[email protected]

401-453-7560

Sponsors and collaborators

Lead sponsor

Women and Infants Hospital of Rhode Island

Other

Registry information

Official study 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

Acronym: META

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
May 1, 2025
Registry last updated
May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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