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Recruiting
NCT05652036
Procedural Discomfort Related to Number of Intradetrusor Botox Injections
Conditions: Overactive Bladder
Sex: Female
Ages: 18 Years – N/A
Phase: PHASE4
Enrollment: 131
Sponsor: The Methodist Hospital Research Institute
Location: United States
Summary
Injection of intradetrusor OnabotulinumtoxinA (BTX-A) is a highly efficacious therapy with a reliable safety profile and demonstrable improvements in subjective and objective measures for overactive bladder (OAB) symptom control.
This procedure can be performed in the office with an evidence-based standard dosing of 100 units for idiopathic OAB.
This is a single-blinded, randomized control trial is to evaluate and optimize the technique for performing intradetrusor injections of BTX-A for idiopathic OAB.
This trial proposes two different reconstitution and injection schema to study patient-centered outcomes related to procedural discomfort and symptom relief.
Eligibility Criteria
Inclusion Criteria:Women scheduled to undergo 100 units intradetrusor BTX-A injections in the office for the diagnosis of idiopathic overactive bladder within the departments of Urology and Urogynecology18 years of age or olderAble to give informed consent in English or SpanishUnderstand and are willing to undergo follow-up and complete all questionnaires as described in this protocolExclusion Criteria:Neurogenic bladder related to prior diagnosis of neurological conditions such as cerebral vascular accident within 6 months prior to treatment, Parkinson's Disease, Multiple Sclerosis, myelomeningocele, traumatic neurologic or spinal injury, or idiopathic diagnosis of neurogenic bladder.Symptomatic UTI at the time of procedure, defined as positive nitrites or high-volume leukocyte esterase on urine dip in addition to at least one of the following symptoms: dysuria, gross hematuria, suprapubic pain, frequency/urgency above baselineDiagnosis of a bladder pain syndrome or other chronic pain syndromes including fibromyalgia, chronic pelvic pain, pelvic floor dysfunction, levator myalgiaKnown bladder malignancyPrevious history of bladder augmentation or reconstructive surgery not related to prolapse
Source: ClinicalTrials.gov (NCT05652036). StuddyBuddy aggregates publicly available trial information.