Women & Infants Hospital
Providence, Rhode Island, 02903, United States
Location status: Recruiting
Location contact
Colin Russell, MD, MPH
CONTACT
Vivian Sung, MD, MPH
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06953271
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.
Interested in participating?
Request Info18 year and older
Female
Interventional
Phase 4
Providence, Rhode Island, 02903, United States
Location status: Recruiting
Colin Russell, MD, MPH
CONTACT
Vivian Sung, MD, MPH
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Oral antibiotics
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Colin Russell, MD, MPH
CONTACT
Kyle Wohlrab, MD
CONTACT
Women and Infants Hospital of Rhode Island
Other
Methenamine Hippurate Compared to Typical Antibiotic Prophylaxis in the Prevention of Urinary Tract Infection Following Intradetrusor OnabotulinumtoxinA Injection for Treatment of Overactive Bladder: a Randomized Controlled Non-Inferiority Trial
Acronym: META
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06659536
Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications
Paris, France
View Trial DetailsNCT07553065
Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications
Reno, Nevada, United States
View Trial DetailsNCT07335484
Digestive System Diseases, Fecal Incontinence
North Adelaide, South Australia, Australia
View Trial DetailsNCT06789406
Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications
Chicago, Illinois, United States
View Trial Details