OnabotulinumtoxinA for OAB via 1 vs 10 Injections: A Randomized Clinical Trial

Thursday, October 24, 2024

8:49 AM – 8:53 AM EDT

Location: Liberty Ballroom (Meeting Level 4)

Figure 1 Change from Baseline OAB-Q Symptom Severity Scores by Treatment Group by Month.

Table 1 Procedural VAS-Pain Score, Post-Procedure Outcomes and Adverse Events, and Global Impression of Improvement

Table 1 Secondary Outcomes.docx

Objectives: Intradetrusor OnabotulinumtoxinA (BTX-A) is a well-established treatment for overactive bladder (OAB) with and without urinary urgency incontinence (UUI). While this treatment’s efficacy in comparison to alternative therapies including anticholinergic medications and sacral neuromodulation has been studied, the ideal number of injection sites within the bladder has not been well established. The primary objective of this study was to evaluate the efficacy of 1 versus 10 BTX-A injections for idiopathic OAB with and without UUI in women. Secondary objectives included analysis of procedural pain, adverse events, quality of life, and post-void residual (PVR) in both groups.

Methods: This was a single-blinded, multi-center randomized clinical trial evaluating the efficacy, safety, and tolerability of one intradetrusor injection site of BTX-A for idiopathic OAB in women. Subjects were randomized to receive 100 units/10mL via either 1 or 10 intradetrusor injections. Efficacy was assessed with a bladder symptom questionnaire (Overactive Bladder Questionnaire, OAB-Q) at both 1 month and 3 months post-procedure. The primary outcome was the OAB-Q symptom severity subscale change from baseline at 1-month post-procedure. Procedural pain was assessed using the visual analog scale of pain. Further secondary outcome variables included VAS-pain, PVR, estimated blood loss (EBL), adverse events, and quality of life and global improvement assessments.

Results: One hundred sixteen subjects were randomized with 58 in the 1-injection arm and 58 in the 10-injection arm. The mean decrease in the OAB-Q symptom severity subscale score at 1 month was -31.2 (± 26.25) in the 1-injection arm versus -39.5 (± 23) in the 10-injection arm (P=0.09) (Figure 1). At 3 months post-procedure, the mean decrease in the OAB-Q symptom severity subscale was -31.0 (± 25.36) in the 1-injection group versus -39.3 (±25.71) in the 10-injection group (P=0.13). The mean improvement in the OABQ health related quality of life subscale scores at 1 month and 3 months post-procedure were 26.9 (± 26.17) and 31.4 (± 25.13) in the 1-injection arm and 33.5 (±22.47) and 34.8 (±20.64) in the 10-injection arm (P=0.11, P=0.34). The immediate post-procedure VAS-pain scores were 25.7 (±27.87) and 31.7 (±26.47) for 1 and 10-injections, respectively (P=0.09). The mean PVR values at 1 month were 83.4 mL (±82.45) for 1-injection and 83.5 (±75.48) for the 10-injection group (P=0.84). Adverse event rates including UTI, urinary retention, and catheterization were similar between groups. At 3 months, patients were largely improved in both groups (Table1).

Conclusions: Efficacy of 100 units intradetrusor OnabotulinumtoxinA injection for idiopathic OAB was not different between the 1-injection and 10-injection groups. Additionally, there were no differences in procedural pain, PVR, EBL, and UTI or urinary retention rates.

Disclosure(s):

Carly Crowder, MD: No financial relationships to disclose

Emily L. Whitcomb, MD: No financial relationships to disclose

Noelani Guaderrama, MD: No financial relationships to disclose

Jun Ihara, M. D.: No financial relationships to disclose

Dena Moskowitz, MD: No relevant disclosure to display

Olivia Chang, MD, MPH: No financial relationships to disclose

Jennifer K. Lee, MD: No financial relationships to disclose

Felicia Lane, MS, MD: No relevant disclosure to display

Taylor Brueseke, MD: No financial relationships to disclose

Presenting Author(s)

Carly Crowder, MD (she/her/hers)

Assistant Professor, Urogynecology
UC Irvine Medical Center
Orange, California, United States

Disclosure(s): No financial relationships to disclose

Co-Author(s)

EW

Emily L. Whitcomb, MD (she/her/hers)

Partner, Southern California Permanente Medical Group
SCPMG
Irvine, California, United States

Disclosure(s): No financial relationships to disclose
NG

Noelani Guaderrama, MD (she/her/hers)

Division Director
Southern California Permanente Medical Group
Irvine, California, United States

Disclosure(s): No financial relationships to disclose
JI

Jun Ihara, M. D.

Physician
So Calif Permanente Med Group
Anaheim, California, United States

Disclosure(s): No financial relationships to disclose
Dena Moskowitz, MD

Associate Professor
UC Irvine Health
Orange, California, United States

Disclosure(s): No relevant disclosure to display
Olivia Chang, MD, MPH (she/her/hers)

Associate Professor, Division Chief of Female Urology
University of California Irvine
Orange, California, United States

Disclosure(s): No financial relationships to disclose
JL

Jennifer K. Lee, MD

Partner physician, Division of Urogynecology
Southern California Permanente Medical Group
Anaheim, California, United States

Disclosure(s): No financial relationships to disclose
Felicia Lane, MS, MD (she/her/hers)

Division Director of Urogynecology and Reconstructive Pelvic Surgery
University of California Irvine
Irvine, California, United States

Disclosure(s): No relevant disclosure to display
TB

Taylor Brueseke, MD

Associate Professor
University of California, Irvine
Orange, California, United States

Disclosure(s): No financial relationships to disclose