Stress Urinary Incontinence
Conditions
Keywords
Stress urinary incontinence, Mixed urinary incontinence, Midurethral sling
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.
Interventions
DEVICEGynecare TVT Exact Continence System
Participants will have placement of Gynecare TVT Exact sling.
DEVICENeomedic KIM (Knotless Incontinence Mesh)
Participants will have placement of retropubic Neomedic KIM (Knotless Incontinence Mesh) sling
Sponsors
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Success at 6 Weeks After Surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Mesh Exposure Thru 1 Year After Surgery | up to 1 year after surgery | Sling mesh exposure identified on examination thru 1 year after surgery |
| Number of Participants With Treatment Success at 1 Year After Surgery | up to 1 year | 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. |
| Number of Participants Requiring Reoperation for Mesh Complications or Urinary Retention Thru 1 Year After Surgery | up to 1 year | Reoperation for mesh complications or urinary retention thru 1 year after initial sling surgery |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Gynecare Tension-free Vaginal Tape (TVT) Exact Sling Participants who are planning surgery for SUI are randomized to have placement of Gynecare TVT Exact sling and followed postoperatively for 1 year.
Gynecare TVT Exact Continence System: Participants will have placement of Gynecare TVT Exact sling. | 73 |
| Neomedic Knotless Incontinence Mesh (KIM) Sling Participants who are planning surgery for SUI are randomized to have placement of retropubic Neomedic KIM sling and followed postoperatively for 1 year.
Neomedic KIM (Knotless Incontinence Mesh): Participants will have placement of retropubic Neomedic KIM (Knotless Incontinence Mesh) sling | 74 |
| Total | 147 |
Baseline characteristics
| Characteristic | Gynecare Tension-free Vaginal Tape (TVT) Exact Sling | Neomedic Knotless Incontinence Mesh (KIM) Sling | Total |
|---|---|---|---|
| Age, Continuous | 58.0 years STANDARD_DEVIATION 12.7 | 59.7 years STANDARD_DEVIATION 12.1 | 58.9 years STANDARD_DEVIATION 12.4 |
| Current smoker | 9 Participants | 10 Participants | 19 Participants |
| Diabetes | 6 Participants | 8 Participants | 14 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 8 Participants | 15 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) White | 63 Participants | 62 Participants | 125 Participants |
| Region of Enrollment United States | 73 Participants | 74 Participants | 147 Participants |
| Sex: Female, Male Female | 73 Participants | 74 Participants | 147 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 73 | 0 / 74 |
| other Total, other adverse events | 9 / 73 | 6 / 74 |
| serious Total, serious adverse events | 0 / 73 | 0 / 74 |
Outcome results
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.
Time frame: 6 weeks after surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Gynecare Tension-free Vaginal Tape (TVT) Exact Sling | Number of Participants With Treatment Success at 6 Weeks After Surgery | 61 Participants |
| Neomedic Knotless Incontinence Mesh (KIM) Sling | Number of Participants With Treatment Success at 6 Weeks After Surgery | 51 Participants |
p-value: 0.0495% CI: [1.1, 28.5]Chi-squared
Secondary
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
Time frame: up to 1 year
Population: The overall number of participants analyzed was less than the number who completed the study at 6 weeks as some participants did not follow-up at 1 year. This outcome measure was based on data collection from in-person visits, phone calls and electronic medical record review. Thus, the number of participants analyzed for this secondary outcome was different than the number analyzed for the other secondary outcome measures.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Gynecare Tension-free Vaginal Tape (TVT) Exact Sling | Number of Participants Requiring Reoperation for Mesh Complications or Urinary Retention Thru 1 Year After Surgery | 0 Participants |
| Neomedic Knotless Incontinence Mesh (KIM) Sling | Number of Participants Requiring Reoperation for Mesh Complications or Urinary Retention Thru 1 Year After Surgery | 0 Participants |
Secondary
Number of Participants With Mesh Exposure Thru 1 Year After Surgery
Sling mesh exposure identified on examination thru 1 year after surgery
Time frame: up to 1 year after surgery
Population: The overall number of participants analyzed was less than the number who completed the study at 6 weeks as some participants did not follow-up at 1 year. Because this outcome measure required an in-person visit, the number of participants analyzed was lower than those for the other secondary outcome measures.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Gynecare Tension-free Vaginal Tape (TVT) Exact Sling | Number of Participants With Mesh Exposure Thru 1 Year After Surgery | 6 Participants |
| Neomedic Knotless Incontinence Mesh (KIM) Sling | Number of Participants With Mesh Exposure Thru 1 Year After Surgery | 1 Participants |
p-value: 0.11Chi-squared
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.
Time frame: up to 1 year
Population: The overall number of participants analyzed was less than the number who completed the study at 6 weeks as some participants did not follow-up at 1 year. This outcome depended on completion of a questionnaire, which were collected on-line as well as during in-person visits. Thus, the number of participants analyzed for this secondary outcome was different than the number analyzed for the other secondary outcome measures.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Gynecare Tension-free Vaginal Tape (TVT) Exact Sling | Number of Participants With Treatment Success at 1 Year After Surgery | 55 Participants |
| Neomedic Knotless Incontinence Mesh (KIM) Sling | Number of Participants With Treatment Success at 1 Year After Surgery | 53 Participants |
p-value: 0.2995% CI: [-6.2, 21.1]Chi-squared