A Phase 4 interventional study of Methenamine Hippurate and Typically prescribed oral antibiotic prophylaxis in Overactive Bladder (OAB) and Urinary Tract Infection (Diagnosis), sponsored by Women and Infants Hospital of Rhode Island. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by Women and Infants Hospital of Rhode Island · Phase 4, Interventional, and Prevention
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.
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.
858 studies on the registry are indexed under Urinary Bladder, Overactive; 127 are open to participants now.
This study's planned enrollment of 164 is above the median of 70 across 649 interventional studies indexed under Urinary Bladder, Overactive.
Browse Urinary Bladder, Overactive studies →Women and Infants Hospital of Rhode Island is the lead sponsor of 93 studies on the registry; 25 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Typically prescribed oral antibiotic prophylaxis
Participants in the experimental arm will receive methenamine hippurate 1 gram by mouth twice daily for three days.
Drug: Methenamine Hippurate
Drug: Methenamine hippurate 1 gram by mouth twice daily for three days.
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.
Also known as: Oral antibiotics
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
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.
Plan to share: No
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Studies of the drug tested here: Methenamine hippurate
Women and Infants Hospital of Rhode Island