Trial Outcomes & Findings for Study Comparing TVT With TVT-SECUR for the Treatment of Stress Urinary Incontinence (NCT NCT00534365)
NCT ID: NCT00534365
Last Updated: 2017-06-09
Results Overview
Composite outcome defined as absence of urinary incontinence as indicated by the Incontinence Severity Index score of 0 and the absence of any additional surgical or nonsurgical treatment of stress urinary incontinence (SUI) after the index surgery.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
281 participants
Primary outcome timeframe
12 months
Results posted on
2017-06-09
Participant Flow
A total of 281 patients were enrolled. Of these, 18 patients withdrew prior to randomization (including for the following reasons- cancelled surgery (6), did not meet inclusion criteria (4), declined further participation (8)).
Participant milestones
| Measure |
TVT Procedure
Tension-free vaginal tape procedure (TVT)
tension-free vaginal tape: Retropubic mid-urethral sling
|
TVT-SECUR Mini Sling Procedure
TVT-SECUR device
TVT-SECUR device: Mid-urethral mini-sling
|
|---|---|---|
|
Overall Study
STARTED
|
127
|
136
|
|
Overall Study
Received Procedure
|
127
|
129
|
|
Overall Study
Any Follow up
|
126
|
135
|
|
Overall Study
Follow up at 12 Months or More
|
119
|
128
|
|
Overall Study
Included in Intent to Treat Analysis
|
127
|
136
|
|
Overall Study
COMPLETED
|
127
|
129
|
|
Overall Study
NOT COMPLETED
|
0
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study Comparing TVT With TVT-SECUR for the Treatment of Stress Urinary Incontinence
Baseline characteristics by cohort
| Measure |
TVT Procedure
n=127 Participants
Tension-free vaginal tape procedure (TVT)
tension-free vaginal tape: Retropubic mid-urethral sling
|
TVT-SECUR Mini Sling Procedure
n=136 Participants
TVT-SECUR device
TVT-SECUR device: Mid-urethral mini-sling
|
Total
n=263 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.6 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
54.6 years
STANDARD_DEVIATION 10.5 • n=7 Participants
|
54.6 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
127 participants
n=5 Participants
|
136 participants
n=7 Participants
|
263 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
120 Participants
n=5 Participants
|
118 Participants
n=7 Participants
|
238 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
4 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
127 participants
n=5 Participants
|
136 participants
n=7 Participants
|
263 participants
n=5 Participants
|
|
Body mass index
|
30.0 kg/m^2
STANDARD_DEVIATION 5.7 • n=5 Participants
|
29.6 kg/m^2
STANDARD_DEVIATION 6.4 • n=7 Participants
|
29.8 kg/m^2
STANDARD_DEVIATION 6 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Analysis based on per protocol enrollment
Composite outcome defined as absence of urinary incontinence as indicated by the Incontinence Severity Index score of 0 and the absence of any additional surgical or nonsurgical treatment of stress urinary incontinence (SUI) after the index surgery.
Outcome measures
| Measure |
TVT Procedure
n=127 Participants
Tension-free vaginal tape procedure (TVT)
tension-free vaginal tape: Retropubic mid-urethral sling
|
TVT-SECUR Mini Sling Procedure
n=129 Participants
TVT-SECUR device
TVT-SECUR device: Mid-urethral mini-sling
|
|---|---|---|
|
Subjective Cure of Urinary Incontinence at 12 Months After Surgery
|
77 Participants
|
72 Participants
|
SECONDARY outcome
Timeframe: 6 weekOutcome measures
| Measure |
TVT Procedure
n=136 Participants
Tension-free vaginal tape procedure (TVT)
tension-free vaginal tape: Retropubic mid-urethral sling
|
TVT-SECUR Mini Sling Procedure
n=127 Participants
TVT-SECUR device
TVT-SECUR device: Mid-urethral mini-sling
|
|---|---|---|
|
Post Operative Complications at 6 Week or Less
Post opInfection requiring antibiotics
|
5 participants
|
6 participants
|
|
Post Operative Complications at 6 Week or Less
Urinary tract infection
|
9 participants
|
9 participants
|
|
Post Operative Complications at 6 Week or Less
Cardiac or MI
|
0 participants
|
0 participants
|
|
Post Operative Complications at 6 Week or Less
Neurologic
|
0 participants
|
0 participants
|
|
Post Operative Complications at 6 Week or Less
Pulmonary
|
0 participants
|
1 participants
|
|
Post Operative Complications at 6 Week or Less
Ileus or small bowel obstruction
|
0 participants
|
0 participants
|
|
Post Operative Complications at 6 Week or Less
Pelvic abscess
|
0 participants
|
0 participants
|
|
Post Operative Complications at 6 Week or Less
Blood transfusion
|
1 participants
|
0 participants
|
|
Post Operative Complications at 6 Week or Less
Venous thromboembolism
|
1 participants
|
0 participants
|
|
Post Operative Complications at 6 Week or Less
Return to operating room
|
0 participants
|
1 participants
|
|
Post Operative Complications at 6 Week or Less
Hospital readmissions
|
2 participants
|
2 participants
|
|
Post Operative Complications at 6 Week or Less
Emergency room evaluations
|
6 participants
|
5 participants
|
|
Post Operative Complications at 6 Week or Less
Unplanned clinic visits
|
24 participants
|
20 participants
|
SECONDARY outcome
Timeframe: 6 weeks-12 monthsOutcome measures
| Measure |
TVT Procedure
n=136 Participants
Tension-free vaginal tape procedure (TVT)
tension-free vaginal tape: Retropubic mid-urethral sling
|
TVT-SECUR Mini Sling Procedure
n=127 Participants
TVT-SECUR device
TVT-SECUR device: Mid-urethral mini-sling
|
|---|---|---|
|
Long Term Complications > 6 Weeks
Neurologic
|
0 participants
|
1 participants
|
|
Long Term Complications > 6 Weeks
Infection requiring antibiotics
|
0 participants
|
0 participants
|
|
Long Term Complications > 6 Weeks
Cardiac or myocardial infection
|
0 participants
|
0 participants
|
|
Long Term Complications > 6 Weeks
Pulmonary
|
0 participants
|
0 participants
|
|
Long Term Complications > 6 Weeks
Ileu or small bowel obstruction
|
0 participants
|
0 participants
|
|
Long Term Complications > 6 Weeks
Mesh exposure
|
0 participants
|
1 participants
|
|
Long Term Complications > 6 Weeks
Leg pain or difficulty ambulatig
|
1 participants
|
0 participants
|
|
Long Term Complications > 6 Weeks
Fistula
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Please note that no all participants conducted the global improvement scale survey due to loss to follow up.
Outcome measures
| Measure |
TVT Procedure
n=109 Participants
Tension-free vaginal tape procedure (TVT)
tension-free vaginal tape: Retropubic mid-urethral sling
|
TVT-SECUR Mini Sling Procedure
n=105 Participants
TVT-SECUR device
TVT-SECUR device: Mid-urethral mini-sling
|
|---|---|---|
|
Patient Global Impression Improvement
Very much better
|
63 Participants
|
67 Participants
|
|
Patient Global Impression Improvement
Much better
|
24 Participants
|
24 Participants
|
|
Patient Global Impression Improvement
Somewhat better
|
11 Participants
|
9 Participants
|
|
Patient Global Impression Improvement
No different
|
3 Participants
|
1 Participants
|
|
Patient Global Impression Improvement
Somewhat worse
|
3 Participants
|
3 Participants
|
|
Patient Global Impression Improvement
Much worse
|
2 Participants
|
0 Participants
|
|
Patient Global Impression Improvement
Very much worse
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 12 monthsThe incontinence severity index comprises the following two questions. How often do you experience urine leakage (0=never, 1=less than once a month, 2=one or several times a month, 3=one or several times a week, 4=every day and/or night)? How much urine do you lose each time (1=drops or little, 2=more)? The total score is the score for the first question multiplied by the score for the second question (0=dry, 1-2=slight, 3-4=moderate, 6-8=severe).
Outcome measures
| Measure |
TVT Procedure
n=134 Participants
Tension-free vaginal tape procedure (TVT)
tension-free vaginal tape: Retropubic mid-urethral sling
|
TVT-SECUR Mini Sling Procedure
n=126 Participants
TVT-SECUR device
TVT-SECUR device: Mid-urethral mini-sling
|
|---|---|---|
|
Incontinence Severity Index Score
|
2.2 units on a scale
Standard Deviation 2.7
|
1.5 units on a scale
Standard Deviation 1.9
|
Adverse Events
TVT-SECUR Mini Sling Procedure
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
TVT Procedure
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
TVT-SECUR Mini Sling Procedure
n=136 participants at risk
TVT-SECUR device
TVT-SECUR device: Mid-urethral mini-sling
|
TVT Procedure
n=127 participants at risk
Tension-free vaginal tape procedure (TVT)
tension-free vaginal tape: Retropubic mid-urethral sling
|
|---|---|---|
|
Injury, poisoning and procedural complications
Bladder injury
|
0.74%
1/136 • Number of events 1 • Intraoperative complications at time of surgery
|
4.7%
6/127 • Number of events 6 • Intraoperative complications at time of surgery
|
|
Blood and lymphatic system disorders
Blood transfusion
|
0.74%
1/136 • Number of events 1 • Intraoperative complications at time of surgery
|
0.00%
0/127 • Intraoperative complications at time of surgery
|
|
Injury, poisoning and procedural complications
Ureteral injury
|
2.2%
3/136 • Number of events 3 • Intraoperative complications at time of surgery
|
0.00%
0/127 • Intraoperative complications at time of surgery
|
|
Injury, poisoning and procedural complications
Bowel injury
|
0.74%
1/136 • Number of events 1 • Intraoperative complications at time of surgery
|
1.6%
2/127 • Number of events 2 • Intraoperative complications at time of surgery
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place