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
Newly published data in the American Journal of Obstetrics and Gynecology provides evidence that Solyx demonstrated comparably high efficacy to TMUS in the treatment of SUI at 36 months.
Primary Endpoint Results
|Treatment Success||Solyx (n=104)||Obtryx II (n=108)|
White, A. B., Kahn, B. S., Gonzalez, R. R., Rosamilia, A., Anger, J. T., Eilber, K. S., & Schaffer, J. (2020). Prospective study of a single incision sling vs. a Transobturator sling in women with stress urinary incontinence: 3 year results. American Journal of Obstetrics and Gynecology. https://doi.org/10.1016/j.ajog.2020.03.008
SOLYX DEMONSTRATED SIGNIFICANT PATIENT IMPROVEMENT
Solyx improved women’s symptom bother, symptom severity and quality of life.
White AB, Eilber KS, Anger JT, Kahn BS, Schaffer JI. A Prospective Parallel Cohort, Multi-center Study of the Solyx™ Single Incision Sling System vs. the Obtryx™ II Sling System for the Treatment of Women with Stress Urinary Incontinence: Patient-Reported Outcomes at 3 Years. Oral Presentation, American Urological Association, Chicago, Illinois (May 2019). 114th Annual Scientific Meeting of the American Urological Association.
SOLYX IMPROVED SEXUAL FUNCTION
Following the procedure women reported better sexual function at each follow up visit.
Pelvic Impact Sexual Questionnaire (PISQ-12)
|Treatment||Propensity Adjusted Treatment Difference|
|Study Visit||SIS†||TMUS†||Estimate [95% CI]||p-value|
33.3 ± 7.1(113)
33.7 ± 6.5(103)
[-3.0 , 1.3]
38.9 ± 4.7(97)
39.4 ± 4.8(93)
[-2.2 , 1.3]
39.0 ± 4.6(88)
39.8 ± 5.2(90)
[-2.8 , 0.9]
38.5 ± 5.6(87)
40.4 ± 5.3(90)
[-3.7 , 0.3]
38.5 ± 4.8(79)
39.6 ± 5.3(82)
[-3.1 , 1.3]
37.9 ± 5.6(80)
40.1 ± 5.2(77)
[-4.7 , -0.2]
White AB, Eilber KS, Anger JT, Kahn BS, Schaffer JI. Female Sexual Function following Sling Surgery: A Prospective Parallel Cohort, Multi-center Study of the Solyx™ Single Incision Sling System vs. the Obtryx™ II Sling System (FDA- Mandated 522 Results at 36 Months). Oral Presentation, Joint Scientific Meeting of the American Urogynecologic Society and International Urogynecological Association, Nashville, Tennessee (September 2019). 40th Annual Scientific Meeting of the American Urogynecologic Society and 44th Annual Meeting of the International Urogynecological Association.
|Adverse Events||Solyx Intent-to-Treat
|Obtryx II Intent-to-Treat Subjects
|Events||Proportion of Subjects with ≥1 Events||Events||Proportion of Subjects with ≥1 Events||p-value|
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 its 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.
women treated with our products in
clinical studies around the world
sponsored research (ISR) studies
in post-market 522
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