Procedural Discomfort Related to Number of Intradetrusor Botox Injections

Launched by THE METHODIST HOSPITAL RESEARCH INSTITUTE · Dec 7, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at how the number of Botox injections given directly into the bladder affects discomfort and symptoms for women with overactive bladder (OAB). The study will compare two different methods of preparing and giving these injections to see which one causes less discomfort and offers better relief from OAB symptoms. The trial is designed to help improve the injection process, making it easier and more comfortable for patients.

To participate, women must be at least 18 years old and scheduled to receive 100 units of Botox injections for OAB. They should be able to understand and answer follow-up questions in English or Spanish. However, certain conditions like a recent stroke, ongoing urinary infections, or previous bladder surgery may exclude some individuals from joining. Participants can expect a supportive environment where their experiences will help shape future treatments.

Gender

FEMALE

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 Urogynecology
• • 18 years of age or older
• • Able to give informed consent in English or Spanish
• • Understand and are willing to undergo follow-up and complete all questionnaires as described in this protocol
• Exclusion 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 baseline
• • Diagnosis of a bladder pain syndrome or other chronic pain syndromes including fibromyalgia, chronic pelvic pain, pelvic floor dysfunction, levator myalgia
• • Known bladder malignancy
• • Previous history of bladder augmentation or reconstructive surgery not related to prolapse

Trial Officials