Reduced Site Injection Protocol of Intra-detrusor Onabotulinumtoxin-A for Treatment of Idiopathic Refractory Urgency Urinary Incontinence
University of Virginia
Summary
The overall objective of this study is to determine if a reduced injection site protocol (5 injection sites) using an equivalent amount of Botox provides comparable relief of Urgency Urinary Incontinence (UUI) symptoms compared to the standard injection site protocol (15-20 injection sites). Our central hypothesis is that the 5-site injection protocol is non-inferior in terms of relief of UUI symptoms compared to the standard injection site protocol, measured by a non-inferior reduction in the number of UUI episodes per day.
Description
English speaking women ≥21 years old with idiopathic refractory urgency urinary incontinence who have failed first and second line treatment (life style modifications and antispasmodic medications) who are undergoing a first injection of intra-detrusor Botox will be recruited to participate in this study. Failure of first and second line treatment will be defined as no improvement in urgency urinary incontinence episodes after trial of lifestyle modifications and use of at least one antispasmodic agent. Patients who are planning to undergo her first intra-detrusor Botox procedure for refracto…
Eligibility
- Age range
- 21+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Females at least 21 years of age * English speaking * Five or more urge urinary incontinence episodes on a three-day voiding diary. Urge incontinence episodes will be determined based on voiding diary and subject indication of coincident urge symptoms, allowing for self-characterization of incontinence type * Urge predominant (urge \>50% of total incontinent episodes) urinary incontinence based on self-reported characterization of incontinent episodes on diary * Patient or caregiver willing to perform clean intermittent catheterization, or patient willing to have indwell…
Interventions
- ProcedureStandard of care (15 Botox injections)
The controls will be given the standard of care of 15 Botox injections.
- ProcedureExperimental Arm (5 Botox injections)
5 Botox injections will be given, with each injection containing three times the amount of Botox than each of the 15 injections given in the standard of care arm.
Location
- University of VirginiaCharlottesville, Virginia