Clinical trial NCT04985799: Comparing KIM to TVT Exact Sling
Official title: A Randomized Controlled Trial Comparing Retropubic KIM Sling to TVT Exact Midurethral Sling
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Keywords: Stress urinary incontinence
Mixed urinary incontinence
Midurethral sling
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2021-08-02
Enrollment: 147
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Midurethral slings (MUS) are recognized as a minimally invasive treatment of SUI. The retropubic route of MUS placement has a cure rate of 89.1% with long term subjective cure rates ranging from 51-88%. The Neomedic Knotless Incontinence Mesh (KIM) sling is a tension-free macroporous monofilament polypropylene knotless mesh designed to be resistant to elongation and deformation over time. The KIM sling also offers a reusable trocar, which results in less waste and cost- savings. KIM sling trocars are available for the retropubic route or trans-obturator (TOT) route.

While studies have been performed comparing the TOT approach of the KIM sling to other slings, no studies have been performed to date with the retropubic (RP) approach. The RP and TOT approaches to MUS have been shown to be equivalent in the treatment of SUI. Since the same mesh material of the KIM sling is used for both the TOT and RP approach, it can be hypothesis that the RP route would show similar treatment success rates.

A type 1 macroporous (\> 75um) polypropylene mesh is the most appropriate material for vaginal implantation. However, literature has suggested that the design and weave of synthetic mesh material can also have a significant effect on efficacy and safety; therefore, the novel design of the KIM may be beneficial to reduce complications. If there is similar efficacy with the RP approach of the KIM sling to the TVT Exact, there will be benefit of reduced costs and the potential for less complications. With this study, the objective is to show non-inferiority of the KIM sling to the Gynecare TVT Exact.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Number of Participants With Treatment Success at 6 Weeks After Surgery
timeFrame: 6 weeks after surgery
Secondary outcomes:
measure: Number of Participants With Treatment Success at 1 Year After Surgery
timeFrame: up to 1 year
measure: Number of Participants Requiring Reoperation for Mesh Complications or Urinary Retention Thru 1 Year After Surgery
timeFrame: up to 1 year
measure: Number of Participants With Mesh Exposure Thru 1 Year After Surgery
timeFrame: up to 1 year after surgery
Other outcomes:
Locations:
city: Hillsborough
country: United States
facility: UNC Hospitals Hillsborough Campus
state: North Carolina
city: Raleigh
country: United States
facility: Rex Hospital
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Jennifer Wu, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill
name: Christina Kunycky, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.