Midurethral Sling vs OnabotulinimtoxinA in Women with Mixed Urinary Incontinence

Wednesday, October 23, 2024

1:30 PM – 1:40 PM EDT

Location: Liberty Ballroom (Meeting Level 4)

Urogenital Distress Inventory (UDI) Total (A), Irritative (B), and Stress (C) Scores

Overactive Bladder Questionnaire (OAB-q) Symptom Severity Score (A), OAB-q Health-Related Quality of Life Score (B), and Overactive Bladder Satisfaction Questionnaire (OAB-SAT-q) Treatment Satisfaction Score (C)

Objectives: To assess whether intradetrusor injection of 100 units of onabotulinimtoxinA (BTX) is superior to midurethral sling (MUS) for women with mixed urinary incontinence (MUI) symptoms refractory to conservative treatment and oral medications.

Methods: A randomized, multi-center trial of BTX vs. MUS for the treatment of MUI was conducted. Eligible participants reported at least moderate bother from both stress (SUI) and urgency (UUI) incontinence symptoms based on the Urogenital Distress Inventory (UDI), demonstrated objective SUI, and had >4 UUI episodes on 3-day bladder diary. Randomization was 1:1, stratified by site and age (≥65, < 65). BTX recipients could receive an additional injection between 3-6 months. Participants could receive additional treatment (including crossover to the alternative intervention) between 6-12 months. Additional treatment prior to 6 months was a protocol violation. The primary outcome was change from baseline in UDI total score at 6 months. Other efficacy outcomes included UDI sub-scores, bladder diary, and other symptom, quality of life and global impression outcomes. Groups were compared via repeated measures linear models, adjusting for site, age category and baseline UDI severity.

Results: 137 participants were randomized, treated, and had post-baseline data (71 BTX, 66 MUS). Mean age was 59 (11.5) years, 80% were White, 15% were Black/African American, and 15% were Latina. Mean BMI was 34.6 (7.9). Both groups reported improvement in total-UDI score at 6 months with no difference between BTX and MUS (-67 vs. -85 points, P=0.12). The UDI-irritative and UDI-stress scores also improved in both groups at 6 months. While there was no difference in UDI-irritative score between groups (-33 vs. -27 points P=0.27), MUS had greater UDI-stress score improvement (-45 points) than BTX (-25, P< 0.001). At 12 months, MUS had greater improvement than BTX in both the total-UDI and UDI-stress scores but not the UDI-irritative score (Figure 1). In the BTX group, 13% received a second injection by 6 months and 28% by 12 months. There was no difference in crossover treatment between BTX and MUS at 6 months (3% vs 8%, P=0.26), but by 12 months there was a higher number in the MUS group that received BTX (30%) compared to those in the BTX group that received MUS (15%, P=0.04). There was no difference between BTX and MUS in secondary outcomes at 6 or 12 months, including the Overactive Bladder Questionnaire (OAB-q) and Overactive Bladder Satisfaction Questionnaire (OAB-SAT-q) (Figure 2), reduction in UUI episodes per day (6 months: -1.9 vs. -1.4, P=0.31; 12 months: -1.7 vs. -1.7, P=0.88), and other patient reported outcome measures.

Conclusions: Both BTX and MUS are associated with improvement in MUI symptoms at 6 and 12 months, thereby allowing for individualized treatment approaches based on patients’ preference.

Disclosure(s):

Heidi S. Harvie, MD, MSCE, MBA: No financial relationships to disclose

Holly E. Richter, PhD, MD: No relevant disclosure to display

Shawn Menefee, MD: No financial relationships to disclose

Vivian Sung, MD MPH: No financial relationships to disclose

Christopher Chermansky, MD: Amber Therapeutics: Advisory Board (Ongoing); Cook Myosite: Clinical Trial Investigator (Ongoing)

David D. Rahn, MD: No financial relationships to disclose

Cindy Amundsen, MD: No relevant disclosure to display

Evan Rhodes, BSPH: No financial relationships to disclose

Sonia M. Thomas, DrPH: No financial relationships to disclose

Donna Mazloomdoost, MD: No financial relationships to disclose

Presenting Author(s)

Heidi S. Harvie, MD, MSCE, MBA (she/her/hers)

Associate Professor
University of Pennsylvania
Philadelphia, Pennsylvania, United States

Disclosure(s): No financial relationships to disclose

Co-Author(s)

Holly E. Richter, PhD, MD

Professor
University of Alabama at Birmingham
Birmingham, Alabama, United States

Disclosure(s): No relevant disclosure to display
Shawn Menefee, MD

Division Director
Kaiser Permanente
San Diego, California, United States

Disclosure(s): No financial relationships to disclose
Vivian Sung, MD MPH (she/her/hers)

Professor
Women and Infants Hospital/Alpert Medical School of Brown University,
Providence, Rhode Island, United States

Disclosure(s): No financial relationships to disclose
CC

Christopher Chermansky, MD (he/him/his)

Chief of Urology at Magee Womens Hospital
UPMC Magee Womens Hospital
Pittsburgh, Pennsylvania, United States

Disclosure(s): Amber Therapeutics: Advisory Board (Ongoing); Cook Myosite: Clinical Trial Investigator (Ongoing)
David D. Rahn, MD (he/him/his)

Professor of Ob/Gyn
University of Texas Southwestern Medical Center
Dallas, Texas, United States

Disclosure(s): No financial relationships to disclose
Cindy Amundsen, MD

Professor of Obstetrics and Gynecology, Professor of Urology
Duke University

Disclosure(s): No relevant disclosure to display
ER

Evan Rhodes, BSPH

Statistician II
RTI International
Durham, North Carolina, United States

Disclosure(s): No financial relationships to disclose
ST

Sonia M. Thomas, DrPH

Senior Research Statistician
RTI
Research Triangle Park, North Carolina, United States

Disclosure(s): No financial relationships to disclose
Donna Mazloomdoost, MD (she/her/hers)

Medical Officer
NIH
Bethesda, Maryland, United States

Disclosure(s): No financial relationships to disclose