Comparing KIM to TVT Exact Sling

Stress Urinary Incontinence Clinical Trial

Official title:

A Randomized Controlled Trial Comparing Retropubic KIM Sling to TVT Exact Midurethral Sling

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04985799
• Other study ID #: 21-1324
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 11, 2021
• Est. completion date: August 2024

Study information

• Verified date: August 2023
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 147
• Est. completion date: August 2024
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Device:
• Gynecare TVT Exact Continence System
Participants will have placement of Gynecare TVT Exact sling.
• Neomedic KIM (Knotless Incontinence Mesh)
Participants will have placement of retropubic Neomedic KIM (Knotless Incontinence Mesh) sling

Locations

Country	Name	City	State
United States	UNC Hospitals Hillsborough Campus	Hillsborough	North Carolina
United States	Rex Hospital	Raleigh	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Participants With Treatment Success at 1 Year 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.	up to 1 year
Secondary	Rate of Reoperation for Mesh Complications or Urinary Retention Thru 1 Year After Surgery		up to 1 year
Secondary	Rate of Mesh Exposure Thru 1 Year After Surgery		up to 1 year after surgery