Trial Outcomes & Findings for Post Market Study Of Single Incision Sling Versus Transobturator Sling for Stress Urinary Incontinence (NCT NCT01784588)
NCT ID: NCT01784588
Last Updated: 2021-02-10
Results Overview
An assessment of improvement in stress urinary incontinence at 36 months, by a composite of objective (negative cough stress test with protocol required bladder fill procedure) and subjective measures (subject self reported improvement in their condition, through the Patient Global Impression of Improvement (PGI-I)). The PGI-I scale rates the patient's improvement or worsening of SUI symptoms relative to baseline. The scale is as follows: 1 - Very much better; 2 - Much better; 3 - A little better; 4 - No change' 5 - A little worse; 6 - Much worse; 7 - Very much worse, with the unit of measure being scores on a scale (lower scores indicate a more positive impression of change). Subjects met the definition of treatment success at 36 months if they had an answer of "No" to the item "Direct observation of urine loss with cough provocation" and an Improvement per the PGI-I (a response of "A little better", "Much better", or "Very much better").
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
281 participants
Primary outcome timeframe
Data presented is for 36 months
Results posted on
2021-02-10
Participant Flow
Subject enrollment began on August 1, 2013 and was completed on December 23, 2014.
Participant milestones
| Measure |
Solyx Single Incision Sling System
Solyx Single Incision Sling System
Solyx Single Incision Sling System: Solyx Single Incision Sling System
|
Obtryx II Sling System
Obtryx II Sling System
Obtryx II Sling System: Standard outside-in transobturator sling
|
|---|---|---|
|
Overall Study
STARTED
|
141
|
140
|
|
Overall Study
COMPLETED
|
104
|
108
|
|
Overall Study
NOT COMPLETED
|
37
|
32
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Post Market Study Of Single Incision Sling Versus Transobturator Sling for Stress Urinary Incontinence
Baseline characteristics by cohort
| Measure |
Solyx Single Incision Sling System
n=141 Participants
Solyx Single Incision Sling System
Solyx Single Incision Sling System: Solyx Single Incision Sling System
|
Obtryx II Sling System
n=140 Participants
Obtryx II Sling System
Obtryx II Sling System: Standard outside-in transobturator sling
|
Total
n=281 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.1 Years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
48.9 Years
STANDARD_DEVIATION 11.7 • n=7 Participants
|
49.0 Years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
141 Participants
n=5 Participants
|
140 Participants
n=7 Participants
|
281 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
127 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
232 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 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
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
124 Participants
n=5 Participants
|
123 Participants
n=7 Participants
|
247 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
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
123 participants
n=5 Participants
|
140 participants
n=7 Participants
|
263 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
18 participants
n=5 Participants
|
0 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Body Mass Index
|
29.6 lb/in^2
STANDARD_DEVIATION 7.3 • n=5 Participants
|
29.7 lb/in^2
STANDARD_DEVIATION 6.3 • n=7 Participants
|
29.6 lb/in^2
STANDARD_DEVIATION 6.8 • n=5 Participants
|
|
Smoking Status
Never
|
101 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
189 Participants
n=5 Participants
|
|
Smoking Status
Current
|
13 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Smoking Status
Previous
|
27 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Smoking Status
Unknown
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Diabetes
None
|
136 Participants
n=5 Participants
|
128 Participants
n=7 Participants
|
264 Participants
n=5 Participants
|
|
Diabetes
Insulin Controlled
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Diabetes
Oral Agent Controlled
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Diabetes
Diet Controlled
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Menopausal Status
Premenopausal
|
72 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
152 Participants
n=5 Participants
|
|
Menopausal Status
Perimenopausal
|
16 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Menopausal Status
Postmenopausal
|
53 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
Current Hormone Replacement Therapy (HRT)
None
|
110 Participants
n=5 Participants
|
120 Participants
n=7 Participants
|
230 Participants
n=5 Participants
|
|
Current Hormone Replacement Therapy (HRT)
Oral Estrogen
|
11 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Current Hormone Replacement Therapy (HRT)
Vaginal Estrogen
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Current Hormone Replacement Therapy (HRT)
Combination Replacement Therapy
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Current Hormone Replacement Therapy (HRT)
Transdermal Estrogen
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Current Hormone Replacement Therapy (HRT)
Other
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Hysterectomy
None
|
101 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
207 Participants
n=5 Participants
|
|
Hysterectomy
Vaginal
|
13 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Hysterectomy
Laparotomy
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Hysterectomy
Laparoscopy
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Hysterectomy
Laparoscopic Assisted Vaginal
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Hysterectomy
Robotic
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Data presented is for 36 monthsAn assessment of improvement in stress urinary incontinence at 36 months, by a composite of objective (negative cough stress test with protocol required bladder fill procedure) and subjective measures (subject self reported improvement in their condition, through the Patient Global Impression of Improvement (PGI-I)). The PGI-I scale rates the patient's improvement or worsening of SUI symptoms relative to baseline. The scale is as follows: 1 - Very much better; 2 - Much better; 3 - A little better; 4 - No change' 5 - A little worse; 6 - Much worse; 7 - Very much worse, with the unit of measure being scores on a scale (lower scores indicate a more positive impression of change). Subjects met the definition of treatment success at 36 months if they had an answer of "No" to the item "Direct observation of urine loss with cough provocation" and an Improvement per the PGI-I (a response of "A little better", "Much better", or "Very much better").
Outcome measures
| Measure |
Solyx Single Incision Sling System
n=104 Participants
Solyx Single Incision Sling System
Solyx Single Incision Sling System: Solyx Single Incision Sling System
|
Obtryx II Sling System
n=108 Participants
Obtryx II Sling System
Obtryx II Sling System: Standard outside-in transobturator sling
|
|---|---|---|
|
Number of Subjects Meeting Definition of Treatment Success at 36 Months, by a Composite of Objective and Subjective Measures
|
94 Participants
|
96 Participants
|
Adverse Events
Solyx Single Incision Sling System
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Obtryx II Sling System
Serious events: 1 serious events
Other events: 21 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Solyx Single Incision Sling System
n=141 participants at risk
Solyx Single Incision Sling System
Solyx Single Incision Sling System: Solyx Single Incision Sling System
|
Obtryx II Sling System
n=140 participants at risk
Obtryx II Sling System
Obtryx II Sling System: Standard outside-in transobturator sling
|
|---|---|---|
|
General disorders
Device Extrusion
|
0.71%
1/141 • Number of events 1 • 36 Months
|
0.71%
1/140 • Number of events 1 • 36 Months
|
Other adverse events
| Measure |
Solyx Single Incision Sling System
n=141 participants at risk
Solyx Single Incision Sling System
Solyx Single Incision Sling System: Solyx Single Incision Sling System
|
Obtryx II Sling System
n=140 participants at risk
Obtryx II Sling System
Obtryx II Sling System: Standard outside-in transobturator sling
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/141 • 36 Months
|
0.71%
1/140 • Number of events 1 • 36 Months
|
|
Renal and urinary disorders
Atonic urinary bladder
|
0.00%
0/141 • 36 Months
|
0.71%
1/140 • Number of events 1 • 36 Months
|
|
Renal and urinary disorders
Bladder spasm
|
0.71%
1/141 • Number of events 1 • 36 Months
|
0.00%
0/140 • 36 Months
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/141 • 36 Months
|
0.71%
1/140 • Number of events 1 • 36 Months
|
|
Infections and infestations
Fungal Infection
|
0.00%
0/141 • 36 Months
|
0.71%
1/140 • Number of events 1 • 36 Months
|
|
Renal and urinary disorders
Haematuria
|
0.71%
1/141 • Number of events 1 • 36 Months
|
0.00%
0/140 • 36 Months
|
|
Renal and urinary disorders
Mixed incontinence
|
0.00%
0/141 • 36 Months
|
0.71%
1/140 • Number of events 1 • 36 Months
|
|
Reproductive system and breast disorders
Pelvic Pain
|
0.71%
1/141 • Number of events 1 • 36 Months
|
0.00%
0/140 • 36 Months
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/141 • 36 Months
|
0.71%
1/140 • Number of events 1 • 36 Months
|
|
General disorders
Sensation of pressure
|
0.00%
0/141 • 36 Months
|
0.71%
1/140 • Number of events 1 • 36 Months
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.71%
1/141 • Number of events 1 • 36 Months
|
0.71%
1/140 • Number of events 2 • 36 Months
|
|
Renal and urinary disorders
Urge incontinence
|
0.00%
0/141 • 36 Months
|
1.4%
2/140 • Number of events 2 • 36 Months
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/141 • 36 Months
|
2.1%
3/140 • Number of events 3 • 36 Months
|
|
Renal and urinary disorders
Urinary retention
|
2.8%
4/141 • Number of events 4 • 36 Months
|
4.3%
6/140 • Number of events 6 • 36 Months
|
|
Infections and infestations
Urinary tract infection
|
1.4%
2/141 • Number of events 2 • 36 Months
|
3.6%
5/140 • Number of events 9 • 36 Months
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
1.4%
2/141 • Number of events 2 • 36 Months
|
0.00%
0/140 • 36 Months
|
|
Infections and infestations
Vaginal infection
|
0.71%
1/141 • Number of events 1 • 36 Months
|
0.71%
1/140 • Number of events 1 • 36 Months
|
|
Reproductive system and breast disorders
Vulvovaginal pain
|
0.00%
0/141 • 36 Months
|
0.71%
1/140 • Number of events 1 • 36 Months
|
|
General disorders
Device extrusion
|
2.1%
3/141 • Number of events 3 • 36 Months
|
3.6%
5/140 • Number of events 5 • 36 Months
|
|
General disorders
Medical device site reaction
|
0.00%
0/141 • 36 Months
|
0.71%
1/140 • Number of events 1 • 36 Months
|
|
Reproductive system and breast disorders
Dyspareunia
|
0.71%
1/141 • Number of events 1 • 36 Months
|
0.00%
0/140 • 36 Months
|
Additional Information
Results disclosure agreements
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Restriction type: OTHER