N/A Completed N=147 Randomized Double-blind Treatment

Comparing KIM to TVT Exact Sling

Stress Urinary Incontinence

Source: ClinicalTrials.gov NCT04985799 ↗

Enrolled (actual)

147

Serious AEs

0.0%

Results posted

Aug 2023

Primary outcomePrimary: Number of Participants With Treatment Success at 6 Weeks After Surgery — 61; 51 Participants — p=0.04

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.

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

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.

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.