N/A
N=147
Comparing KIM to TVT Exact Sling
Stress Urinary Incontinence
Bottom Line
View on ClinicalTrials.gov: NCT04985799 ↗Enrolled (actual)
147
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcome: Primary: Number of Participants With Treatment Success at 6 Weeks After Surgery — 61; 51 Participants — p=0.04
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Gynecare TVT Exact Continence System (Device); Neomedic KIM (Knotless Incontinence Mesh) (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- Female
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Success at 6 Weeks After Surgery |
61; 51 | 0.04 sig |
| SECONDARY Number of Participants With Treatment Success at 1 Year After Surgery |
55; 53 | 0.29 |
| SECONDARY Number of Participants Requiring Reoperation for Mesh Complications or Urinary Retention Thru 1 Year After Surgery |
0; 0 | — |
| SECONDARY Number of Participants With Mesh Exposure Thru 1 Year After Surgery |
6; 1 | 0.11 |
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.
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 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.
Data sourced from ClinicalTrials.gov (NCT04985799). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.