Overactive Bladder (OAB), Urinary Tract Infection (Diagnosis)
Conditions
Keywords
Overactive Bladder, onabotulinumtoxinA, Methenamine, Urinary Tract Infection, BOTOX-A, UTI, OAB
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.
Interventions
Drug: Methenamine hippurate 1 gram by mouth twice daily for three days.
DRUGTypically 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.
Sponsors
Women and Infants Hospital of Rhode Island
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute Urinary Tract Infection | 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
| Measure | Time frame | Description |
|---|---|---|
| Medication Satisfaction | 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. |
Countries
United States
Contacts
Primary ContactColin Russell, MD, MPH
Backup ContactKyle Wohlrab, MD
Outcome results
None listed