Clinical Excellence
Boston Scientific is committed to supporting
evidence-based medicine through sponsoring
and funding pelvic floor research worldwide.
The Difference is in the Data
36-MONTH DATA FROM SOLYX SINGLE INCISION SLING SYSTEM 522 STUDY
A Prospective Parallel Cohort, Multi-center Study of the Solyx™ Single Incision Sling System vs. the Obtryx™ II Transobturator Mid-Urethral Sling System for the Treatment of Women with Stress Urinary Incontinence: 3-Year Results.
Solyx Single Incision Sling System 522 post-market clinical study
SOLYX IS EFFECTIVE
At 36-months Solyx has comparable efficacy to the Obtryx II transobturator system.
Primary Endpoint
Improvement in SUI by a composite of:
- Negative cough stress test, and
- Subject reported improvement in their condition by the Patient Global Impression of Improvement (PGI-I)
Primary Endpoint Results
| Treatment Success | Solyx (n=104) | Obtryx II (n=108) |
|---|---|---|
| Composite | 90.4% | 88.9% |
| Objective | 94.2% | 91.7% |
| Subjective | 94.2% | 94.4% |
SOLYX DEMONSTRATED SIGNIFICANT PATIENT IMPROVEMENT
Solyx improved women’s symptom bother, symptom severity and quality of life.
Urogenital Distress Inventory (UDI-6)
Incontinence Severity Index (ISI)
Urinary Impact Questionnaire (UIQ-7)
Patient Global Impression of Improvement (PGI-I)
SOLYX IMPROVED SEXUAL FUNCTION
Following the procedure women reported better sexual function at each follow up visit.
PISQ-12
*Statistically significant at 0.05 level
Pelvic Impact Sexual Questionnaire (PISQ-12)
| Treatment | Propensity Adjusted Treatment Difference | |||
| Study Visit | SIS† | TMUS† | Estimate [95% CI] | p-value |
| Baseline | 33.3 ± 7.1(113) (13.0,35.0,47.0) |
33.7 ± 6.5(103) (15.0,35.0,45.0) |
-0.9 [-3.0 , 1.3] |
0.425 |
| 6 months | 38.9 ± 4.7(97) (22.0,40.0,46.0) |
39.4 ± 4.8(93) (25.0,40.0,47.0) |
-0.5 [-2.2 , 1.3] |
0.603 |
| 12 months | 39.0 ± 4.6(88) (25.0,40.0,46.0) |
39.8 ± 5.2(90) (16.0,41.0,48.0) |
-0.9 [-2.8 , 0.9] |
0.318 |
| 18 months | 38.5 ± 5.6(87) 15.0,39.0,46.0) |
40.4 ± 5.3(90) (25.0,42.0,47.0) |
-1.7 [-3.7 , 0.3] |
0.093 |
| 24 months | 38.5 ± 4.8(79) (24.0,40.0,46.0) |
39.6 ± 5.3(82) (24.0,41.0,48.0) |
-0.9 [-3.1 , 1.3] |
0.421 |
| 36 months | 37.9 ± 5.6(80) (22.0,39.0,45.0) |
40.1 ± 5.2(77) (18.0,41.0,48.0) |
-2.5 [-4.7 , -0.2] |
0.031 |
Adverse Events
| Adverse Events1 | Solyx Intent-to-Treat Subjects (N=141) |
Obtryx II Intent-to-Treat Subjects (N=140) |
|||
| Events | Proportion of Subjects with ≥1 Events | Events | Proportion of Subjects with ≥1 Events | p-value | |
| Mesh exposurea | 4 | 2.8% | 6 | 4.3% | 0.541 |
| Dyspareuniab | 1 | 0.7% | 0 | 0.0% | 1.000 |
| Mesh Erosionc | 0 | 0.0% | 1 | 0.7% | 0.498 |
| Pelvic Paind | 1 | 0.7% | 0 | 0.0% | 1.000 |
| Urinary Retentione | 4 | 2.8% | 6 | 4.3% | 0.541 |
b. Dyspareunia defined as any new onset pain associated with sexual activity that was not present during sexual activity preoperatively; or any worsening pain associated with sexual activity compared to preoperative state.
c. Mesh erosion defined as perforation of mesh into hollow organ or viscus.
d. Pelvic pain defined as any pain associated with worsening bother compared to preop occurring in the lower abdomen or genital area beyond 12 weeks post-operatively (excluding neuromuscular pain and dyspareunia).
e. Urinary retention defined as inability to completely empty the bladder.
Solyx demonstrated comparable outcomes to Obtryx II showing it’s high efficacy, patient quality of life benefits and improvement in sexual function over the course of 3 years.
Our Ongoing Commitment to Clinical Excellence
Boston Scientific is committed to supporting evidence-based medicine through sponsoring and funding pelvic floor research worldwide.
3500+
women treated with our products in
clinical studies around the world
14
currently ongoing investigator-
sponsored research (ISR) studies
150+
physicians collaborating
on research
2
ongoing 522 post-market
clinical studies
60+
clinical studies /
publications
2
additional large-scale
clinical projects
