Livestream

Noninferiority randomized trial of Knotless Incontinence Mesh (KIM) with sterilizable trocars versus TVT Exact

Friday, October 6, 2023

8:42 AM – 8:46 AM US PST

Location: Oregon Ballroom

Presenting Author(s)

Samantha L. Margulies, MD (she/her/hers)

Urogynecologist
OB/GYN Specialists of the Palm Beaches, United States

PDF

Co-Author(s)

AO

Anna E. Osment, MD (she/her/hers)

Resident
UVA
AB

Adele Bernard, BSPH (she/her/hers)

Medical Student
UNC
Durham, North Carolina, United States
MS

Michelle Schroeder, MD

Urogynecologist
Cone Health
Greensboro, North Carolina, United States
IA

Ijeoma Agu, MD

Fellow
University of North Carolina at Chapel Hill
Durham, North Carolina, United States
AA

Amy L. Askew, MD, MPH

Assistant Professor
Medical University of South Carolina
Charleston, South Carolina, United States
Christina A. Kunycky, MD

Urogynecology Fellow
UNC
Durham, North Carolina, United States
CC

Christine Chu, MD

Faculty
UNC
Chapel Hill, North Carolina, United States
EG

Elizabeth Geller, MD (she/her/hers)

Professor
UNC
Raleigh, North Carolina, United States
MW

Marcella G. Willis-Gray, MD

Faculty
UNC- Chapel Hill
Raleigh, North Carolina, United States
Jennifer M. Wu, MD, MPH

Vice Dean for Academic Affairs, UNC SOM; Professor, Department of OB/GYN
University of North Carolina at Chapel Hill, School of Medicine
Chapel Hill, North Carolina, United States

Disclosure(s):

Samantha L. Margulies, MD: No financial relationships to disclose

Anna E. Osment, MD: No financial relationships to disclose

Adele Bernard, BSPH: No financial relationships to disclose

Michelle Schroeder, MD: No financial relationships to disclose

Ijeoma Agu, MD: No financial relationships to disclose

Amy L. Askew, MD, MPH: No financial relationships to disclose

Christina A. Kunycky, MD: No financial relationships to disclose

Christine Chu, MD: No financial relationships to disclose

Elizabeth Geller, MD: Boston Scientific: Unpaid consultant (Ongoing), Unrestricted Research Grant (Ongoing)

Marcella G. Willis-Gray, MD: No financial relationships to disclose

Jennifer M. Wu, MD, MPH: No financial relationships to disclose

Objectives: The Neomedic KIM sling with sterilizable trocars decreases medical waste versus midurethral slings with disposable trocars; however, very limited comparative data exist. Thus, our objective was to assess to the effectiveness of the retropubic KIM sling compared to the Gynecare TVT Exact sling. Secondary outcomes included rates of urinary retention and mesh complications.

Methods: This was a single-center, randomized noninferiority trial comparing outcomes of two retropubic slings—Neomedic Knotless Incontinence Mesh (KIM) sling and Gynecare TVT Exact sling—in women with stress urinary incontinence from August 2021 to May 2023. The primary outcome was subjective effectiveness at six weeks defined by a composite outcome of the response to the question #17 on the PFDI-20 and no retreatment of stress incontinence. Secondary safety outcomes included rates of urinary retention, mesh erosion, reoperation for mesh complications. Sample size estimate based on noninferiority margin of 14%, equal effectiveness of 90%, alpha 0.05 and 80% power with a 20% dropout is 72 per group.

Results: Among 147 patients, 74 (50.3%) were randomized to KIM sling vs 73 (49.7%) to TVT exact. The rates of six-week effectiveness were 68.5% for the KIM sling and 83.3% for the TVT Exact With a risk difference 14.8% (95% confidence interval, 1.1 - 28.5), the KIM sling is not noninferior to the TVT Exact sling. There were no differences in secondary outcomes.

Conclusions: The KIM sling is not inferior to the TVT Exact sling for effectiveness at six weeks based on a composite outcome score. This clinical trial is ongoing to assess outcomes at six months and one year.