Methenamine Hippurate Following Intradetrusor OnabotulinumtoxinA Injection (META)

Women and Infants Hospital of Rhode Island

Status and phase

Not yet enrolling

Phase 4

Conditions

Urinary Tract Infection (Diagnosis)

Overactive Bladder (OAB)

Treatments

Drug: Methenamine Hippurate

Drug: Typically prescribed oral antibiotic prophylaxis

Study type

Interventional

Funder types

Other

Identifiers

NCT06953271

2265134

Details and patient eligibility

About

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.

Full 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.

Enrollment

164 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

164 participants in 2 patient groups

Typically prescribed oral antibiotic prophylaxis

Active Comparator group

Description:

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.

Treatment:

Drug: Typically prescribed oral antibiotic prophylaxis

Methenamine hippurate prophylaxis

Experimental group

Description:

Participants in the experimental arm will receive methenamine hippurate 1 gram by mouth twice daily for three days.

Treatment:

Drug: Methenamine Hippurate