Methenamine Hippurate Following Intradetrusor OnabotulinumtoxinA Injection

ConditionsOveractive Bladder (OAB)Urinary Tract Infection (Diagnosis)

Trial statusNot yet recruiting

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 volunteers

Qualifiers

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
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.

Treatment groups

164 Participants

are divided into 2 treatment groups

Group A: Typically prescribed oral antibiotic prophylaxisActive comparator 1 intervention

Group B: Methenamine hippurate prophylaxisExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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 procedure

Secondary outcomes

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.

Women and Infants Hospital of Rhode Island

Lead sponsor

Source ClinicalTrials.gov

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