Effect of Intradetrusor onabotulinumtoxinA Injection Versus Conservative Management on Female Sexual Function in Patients With Bladder Pain Syndrome

Launched by WALTER REED NATIONAL MILITARY MEDICAL CENTER · Dec 6, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how a specific treatment called intradetrusor onabotulinumtoxinA injection affects sexual function in women suffering from Bladder Pain Syndrome (BPS). BPS is a painful condition that can significantly impact a woman's quality of life, including her sexual health. The study aims to compare this treatment to conservative management options, such as dietary changes and oral medications, to see which approach better helps improve sexual function and overall well-being.

Eligible participants for the trial are women aged 18 and older who have been diagnosed with BPS and have a specific score indicating the severity of their symptoms. Participants will be divided into three groups: those receiving the onabotulinumtoxinA injection, those undergoing conservative management, and a healthy control group for comparison. Throughout the study, participants can expect to complete questionnaires before and after treatment to assess changes in their sexual function and other symptoms. The trial is currently recruiting participants, and it’s important to note that some individuals may not qualify due to specific medical conditions or treatments they are currently receiving.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Female 18 years of age and older
• • For bladder pain syndrome participants: O'Leary Sant score 13 or greater
• • For healthy controls: O'Leary Sant score 12 or less
• • DEERS eligible (care provided by military health care system)
• Exclusion Criteria:
• • Contraindications for bladder Botox
• • Current use of alternative treatment for bladder pain syndrome
• • Neurogenic bladder
• • Other urinary tract disease
• • Pelvic organ prolapse stage 3 or greater
• • Pregnancy or breastfeeding
• • Non-English speakers