Methenamine Hippurate Following Intradetrusor OnabotulinumtoxinA Injection
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorWomen and Infants Hospital of Rhode Island
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years of age or older
undergoing intradetrusor BOTOX-A injections in the office setting for overactive bladder
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Methenamine Hippurate
DrugDrug: Methenamine hippurate 1 gram by mouth twice daily for three days.
Typically prescribed oral antibiotic prophylaxis
DrugDrug: 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.
Treatment groups
164 Participants
are divided into 2 treatment groupsGroup A: Typically prescribed oral antibiotic prophylaxisActive comparator 1 intervention
Group B: Methenamine hippurate prophylaxisExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Date of the BOTOX-A injection to 30 days after the procedureSecondary outcomes
1
Medication Satisfaction
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.
Time frame
Completed over the phone >30 days after BOTOX-A injection.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov