Comparing KIM to TVT Exact Sling

NCT04985799 | Completed Results FDA Device

• 1 other identifier: 21-1324
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 2

Brief Summary

To assess to the non-inferiority of the retropubic Neomedic Knotless Incontinence Mesh (KIM) sling compared to the Gynecare Tension-free Vaginal Tape (TVT) Exact sling. Participants: Women 21 years or older with a diagnosis of stress urinary incontinence (SUI) or mixed urinary incontinence (MUI) with objective evidence of SUI planning surgery for stress urinary incontinence. Procedures (methods): Patients will be randomized to receive either the Gynecare TVT Exact sling or the retropubic Neomedic KIM sling. Patients will be followed for 1 year postoperatively.

Conditions

Stress Urinary Incontinence

Keywords

Stress urinary incontinence; Mixed urinary incontinence; Midurethral sling

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment Success at 6 Weeks After Surgery

  Treatment success is defined by a composite outcome of 1) response of No or "no bother" to question #3 on urogenital distress inventory-6 (UDI-6) validated questionnaire AND no retreatment of stress incontinence.

  6 weeks after surgery

Secondary Outcomes (3)

• Number of Participants With Treatment Success at 1 Year After Surgery

  up to 1 year

• Number of Participants Requiring Reoperation for Mesh Complications or Urinary Retention Thru 1 Year After Surgery

  up to 1 year

• Number of Participants With Mesh Exposure Thru 1 Year After Surgery

  up to 1 year after surgery

Study Arms (2)

Gynecare TVT Exact sling

ACTIVE COMPARATOR

Participants who are planning surgery for SUI are randomized to have placement of Gynecare TVT Exact sling and followed postoperatively for 1 year.

Device: Gynecare TVT Exact Continence System

Neomedic KIM sling

ACTIVE COMPARATOR

Participants who are planning surgery for SUI are randomized to have placement of retropubic Neomedic KIM sling and followed postoperatively for 1 year.

Device: Neomedic KIM (Knotless Incontinence Mesh)

Interventions

Gynecare TVT Exact Continence System DEVICE

Participants will have placement of Gynecare TVT Exact sling.

Also known as: Midurethral sling

Gynecare TVT Exact sling

Neomedic KIM (Knotless Incontinence Mesh) DEVICE

Participants will have placement of retropubic Neomedic KIM (Knotless Incontinence Mesh) sling

Also known as: Midurethral sling

Neomedic KIM sling

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women greater than or equal to 21 years based on medical chart review
• Diagnosis of SUI or mixed urinary incontinence based on medical chart review
• Objective evidence of SUI as indicated by positive cough stress test or urodynamic stress incontinence during urodynamic testing within the last year prior to enrollment. Medical chart will be reviewed.
• Planning surgery for SUI with/without pelvic organ prolapse (POP) surgery

You may not qualify if:

• Current pregnancy, desire for future childbearing, less than or equal to 12 months postpartum at the time of enrollment
• Prior history of surgery for SUI based on medical chart review
• Bladder capacity \<200 mL on Urodynamic testing or post-void residual (PVR) \>150 mL on urodynamic testing or bladder scan.
• Non-ambulatory
• Current genitourinary fistula or urethral diverticulum based on pre-operative exam in the medical chart.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (2)

UNC Hospitals Hillsborough Campus

Hillsborough, North Carolina, 27278, United States

Location

Rex Hospital

Raleigh, North Carolina, 27607, United States

Location

Related Publications (6)

• Padilla-Fernandez B, Garcia-Cenador MB, Gomez-Garcia A, Miron-Canelo JA, Gil-Vicente A, Silva-Abuin JM, Lorenzo-Gomez MF. Results of the surgical correction of urinary stress incontinence according to the type of transobturator tape utilized. Arch Ital Urol Androl. 2013 Sep 26;85(3):149-53. doi: 10.4081/aiua.2013.3.149.

  PMID: 24085238 BACKGROUND

• Imamura M, Hudson J, Wallace SA, MacLennan G, Shimonovich M, Omar MI, Javanbakht M, Moloney E, Becker F, Ternent L, Montgomery I, Mackie P, Saraswat L, Monga A, Vale L, Craig D, Brazzelli M. Surgical interventions for women with stress urinary incontinence: systematic review and network meta-analysis of randomised controlled trials. BMJ. 2019 Jun 5;365:l1842. doi: 10.1136/bmj.l1842.

  PMID: 31167796 BACKGROUND

• Ford AA, Rogerson L, Cody JD, Aluko P, Ogah JA. Mid-urethral sling operations for stress urinary incontinence in women. Cochrane Database Syst Rev. 2017 Jul 31;7(7):CD006375. doi: 10.1002/14651858.CD006375.pub4.

  PMID: 28756647 BACKGROUND

• Richter HE, Albo ME, Zyczynski HM, Kenton K, Norton PA, Sirls LT, Kraus SR, Chai TC, Lemack GE, Dandreo KJ, Varner RE, Menefee S, Ghetti C, Brubaker L, Nygaard I, Khandwala S, Rozanski TA, Johnson H, Schaffer J, Stoddard AM, Holley RL, Nager CW, Moalli P, Mueller E, Arisco AM, Corton M, Tennstedt S, Chang TD, Gormley EA, Litman HJ; Urinary Incontinence Treatment Network. Retropubic versus transobturator midurethral slings for stress incontinence. N Engl J Med. 2010 Jun 3;362(22):2066-76. doi: 10.1056/NEJMoa0912658. Epub 2010 May 17.

  PMID: 20479459 BACKGROUND

• Chapple CR, MacNeil S. The use of implanted materials for treating women with pelvic organ prolapse and stress urinary incontinence. Curr Opin Urol. 2019 Jul;29(4):431-436. doi: 10.1097/MOU.0000000000000619.

  PMID: 30888974 BACKGROUND

• Margulies SL, Osment AE, Bernard A, Schroeder MN, Askew AL, Agu IS, Kunycky CA, Geller EJ, Willis-Gray M, Chu CM, Wu JM. Noninferiority Randomized Clinical Trial: KIM Sling With Reusable Trocars Versus TVT Exact Sling. Urogynecology (Phila). 2025 Feb 1;31(2):101-107. doi: 10.1097/SPV.0000000000001596. Epub 2024 Nov 8.

  PMID: 39514254 DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

Suburethral Slings

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Results Point of Contact

• Title: Jennifer Wu, MD, MPH, Professor of OBGYN
• Organization: University of North Carolina at Chapel Hill

jennifer_wu@med.unc.edu

919-966-0014

Study Officials

• Jennifer Wu, MD, MPH

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• Christina Kunycky, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2021
• First Posted: August 2, 2021
• Study Start: August 11, 2021
• Primary Completion: May 31, 2023
• Study Completion: June 28, 2024
• Last Updated: August 6, 2024
• Results First Posted: August 24, 2023

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 9 to 36 months following publication
• Access Criteria: Approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations

US (2)