Trial Outcomes & Findings for Comparing KIM to TVT Exact Sling (NCT NCT04985799)

Last Updated: 2024-08-06

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

147 participants

Primary outcome timeframe

6 weeks after surgery

Results posted on

2024-08-06

Participant Flow

Participant milestones

Participant milestones
Measure	Gynecare Tension-free Vaginal Tape (TVT) Exact Sling Participants who are planning surgery for stress urinary incontinence (SUI) are randomized to have placement of Gynecare Tension-free Vaginal Tape (TVT) Exact sling and followed postoperatively for 1 year. Gynecare TVT Exact Continence System: Participants will have placement of Gynecare TVT Exact sling.	Neomedic Knotless Incontinence Mesh (KIM) Sling Participants who are planning surgery for stress urinary incontinence (SUI) are randomized to have placement of retropubic Neomedic Knotless Incontinence Mesh (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
Overall Study STARTED	73	74
Overall Study COMPLETED	73	74
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparing KIM to TVT Exact Sling

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gynecare Tension-free Vaginal Tape (TVT) Exact Sling n=73 Participants 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.	Neomedic Knotless Incontinence Mesh (KIM) Sling n=74 Participants 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	Total n=147 Participants Total of all reporting groups
Age, Continuous	58.0 years STANDARD_DEVIATION 12.7 • n=5 Participants	59.7 years STANDARD_DEVIATION 12.1 • n=7 Participants	58.9 years STANDARD_DEVIATION 12.4 • n=5 Participants
Sex: Female, Male Female	73 Participants n=5 Participants	74 Participants n=7 Participants	147 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) White	63 Participants n=5 Participants	62 Participants n=7 Participants	125 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment United States	73 Participants n=5 Participants	74 Participants n=7 Participants	147 Participants n=5 Participants
Diabetes	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Current smoker	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks after surgery

Outcome measures

Outcome measures
Measure	Gynecare Tension-free Vaginal Tape (TVT) Exact Sling n=73 Participants 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.	Neomedic Knotless Incontinence Mesh (KIM) Sling n=74 Participants 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
Number of Participants With Treatment Success at 6 Weeks After Surgery	61 Participants	51 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Gynecare Tension-free Vaginal Tape (TVT) Exact Sling n=67 Participants 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.	Neomedic Knotless Incontinence Mesh (KIM) Sling n=71 Participants 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
Number of Participants With Treatment Success at 1 Year After Surgery	55 Participants	53 Participants

SECONDARY outcome

Timeframe: 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.

Reoperation for mesh complications or urinary retention thru 1 year after initial sling surgery

Outcome measures

Outcome measures
Measure	Gynecare Tension-free Vaginal Tape (TVT) Exact Sling n=68 Participants 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.	Neomedic Knotless Incontinence Mesh (KIM) Sling n=71 Participants 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
Number of Participants Requiring Reoperation for Mesh Complications or Urinary Retention Thru 1 Year After Surgery	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

Sling mesh exposure identified on examination thru 1 year after surgery

Outcome measures

Outcome measures
Measure	Gynecare Tension-free Vaginal Tape (TVT) Exact Sling n=54 Participants 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.	Neomedic Knotless Incontinence Mesh (KIM) Sling n=54 Participants 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
Number of Participants With Mesh Exposure Thru 1 Year After Surgery	6 Participants	1 Participants

Adverse Events

Gynecare TVT Exact Sling

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Neomedic KIM Sling

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Gynecare TVT Exact Sling n=73 participants at risk 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.	Neomedic KIM Sling n=74 participants at risk 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
Renal and urinary disorders Urinary retention	4.1% 3/73 • Number of events 3 • Adverse events are reported from after surgery until 1 year postoperative visit. Data collection occurred through 1 year after surgery for secondary outcomes and adverse events.	6.8% 5/74 • Number of events 5 • Adverse events are reported from after surgery until 1 year postoperative visit. Data collection occurred through 1 year after surgery for secondary outcomes and adverse events.
Renal and urinary disorders Mesh exposure	8.2% 6/73 • Number of events 6 • Adverse events are reported from after surgery until 1 year postoperative visit. Data collection occurred through 1 year after surgery for secondary outcomes and adverse events.	1.4% 1/74 • Number of events 1 • Adverse events are reported from after surgery until 1 year postoperative visit. Data collection occurred through 1 year after surgery for secondary outcomes and adverse events.

Additional Information

Jennifer Wu, MD, MPH, Professor of OBGYN

University of North Carolina at Chapel Hill

Phone: 919-966-0014

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place