Stress Urinary IncontinenceNCT04985799
Comparing KIM to TVT Exact Sling
A study testing Gynecare TVT Exact Continence System and Neomedic KIM (Knotless Incontinence Mesh) in people with Stress Urinary Incontinence, run by University of North Carolina, Chapel Hill at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Gynecare TVT Exact Continence System and Neomedic KIM (Knotless Incontinence Mesh)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Aug 2021to 28 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UNC Hospitals Hillsborough Campus
Hillsborough, North Carolina, 27278
Rex Hospital
Raleigh, North Carolina, 27607
About this study
Official title: A Randomized Controlled Trial Comparing Retropubic KIM Sling to TVT Exact Midurethral Sling
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.
Read the 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.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Gynecare TVT Exact Continence System, Neomedic KIM (Knotless Incontinence Mesh)
- Keywords
- Stress urinary incontinence, Mixed urinary incontinence, Midurethral sling
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gynecare TVT Exact Continence SystemDevice
Also called Midurethral sling
Participants will have placement of Gynecare TVT Exact sling.
Neomedic KIM (Knotless Incontinence Mesh)Device
Also called Midurethral sling
Participants will have placement of retropubic Neomedic KIM (Knotless Incontinence Mesh) sling
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Neomedic KIM (Knotless Incontinence Mesh) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks after surgery
Secondary outcomes (3)
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.
Measured: up to 1 year
Number of Participants Requiring Reoperation for Mesh Complications or Urinary Retention Thru 1 Year After Surgery
Reoperation for mesh complications or urinary retention thru 1 year after initial sling surgery
Measured: up to 1 year
Number of Participants With Mesh Exposure Thru 1 Year After Surgery
Sling mesh exposure identified on examination thru 1 year after surgery
Measured: up to 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start11 Aug 2021
- Primary completion31 May 2023
- Study completion28 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Wu, MD, MPH, Principal investigator, University of North Carolina, Chapel HillChristina Kunycky, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04985799
- Sponsor's protocol ID
- 21-1324
- Status last verified
- Jul 2024
- First submitted
- 22 Jul 2021
- Last updated
- 6 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with University of North Carolina (UNC)
Publications
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.
PubMed 24085238Imamura 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.
PubMed 31167796Ford 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.
PubMed 28756647Richter 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.
PubMed 20479459Chapple 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.
PubMed 30888974Margulies 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.
PubMed 39514254
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Retropubic KIM Sling to TVT Exact Midurethral Sling
- ClinicalTrials.gov ID
- NCT04985799
- Acronym / sponsor ID
- 21-1324
- Conditions
- Stress Urinary Incontinence
- Keywords
- Stress urinary incontinence, Mixed urinary incontinence, Midurethral sling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- 11 Aug 2021 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 28 Jun 2024 (actual)
- First posted
- 2 Aug 2021 (actual)
- Results
- Posted 24 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gynecare TVT Exact sling | Active comparator | Device: Gynecare TVT Exact Continence SystemParticipants who are planning surgery for SUI are randomized to have placement of Gynecare TVT Exact sling and followed postoperatively for 1 year. |
| Neomedic KIM sling | Active comparator | Device: Neomedic KIM (Knotless Incontinence Mesh)Participants who are planning surgery for SUI are randomized to have placement of retropubic Neomedic KIM sling and followed postoperatively for 1 year. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gynecare TVT Exact Continence SystemAlso: Midurethral slingParticipants will have placement of Gynecare TVT Exact sling. | Device | Gynecare TVT Exact sling |
| Neomedic KIM (Knotless Incontinence Mesh)Also: Midurethral slingParticipants will have placement of retropubic Neomedic KIM (Knotless Incontinence Mesh) sling | Device | Neomedic KIM sling |
Primary outcome
Number of Participants With Treatment Success at 6 Weeks After Surgery
Time frame: 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.
3 secondary outcomes
Number of Participants With Treatment Success at 1 Year After Surgery
Time frame: up to 1 year
Number of Participants Requiring Reoperation for Mesh Complications or Urinary Retention Thru 1 Year After Surgery
Time frame: up to 1 year
Number of Participants With Mesh Exposure Thru 1 Year After Surgery
Time frame: up to 1 year after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24085238Padilla-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.
- Background: PubMed 31167796Imamura 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.
- Background: PubMed 28756647Ford 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.
- Background: PubMed 20479459Richter 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.
- Background: PubMed 30888974Chapple 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.
- Derived from this study: PubMed 39514254Margulies 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.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with University of North Carolina (UNC)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Wu, MD, MPH principal investigator
University of North Carolina, Chapel Hill
Christina Kunycky, MD principal investigator
University of North Carolina, Chapel Hill
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gynecare TVT Exact Continence System and Neomedic KIM (Knotless Incontinence Mesh) in people with Stress Urinary Incontinence, run by University of North Carolina, Chapel Hill at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment Success at 6 Weeks After Surgery (time frame: 6 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04985799, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.