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

The Solyx Single Incision Sling System 522 post-market clinical study is a prospective, parallel cohort, non-inferiority study to assess the safety and efficacy of a single incision sling. This study evaluated the Solyx Single Incision Sling System as compared to the Obtryx II Transobturator Mid-Urethral Sling System, and was shown to be non-inferior in the treatment of stress urinary incontinence (SUI) over 36 months.

281 patients, 21 sites, 2 countries, 25 implanters

Primary Endpoint Results

The Solyx System met the primary endpoint validating that the single-incision sling is non-inferior to the transobturator device in efficacy at 3-year follow-up.

Treatment Success	Solyx (n=104)	Obtryx II (n=108)
Composite	90.4%	88.9%
Objective	94.2%	91.7%
Subjective	94.2%	94.4%

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 IMPROVED SEXUAL FUNCTION

Following the procedure women reported better sexual function at each follow up visit.

Sexual function improves following both Solyx Single Incision Sling System and Obtryx II Transobturator Mid-Urethral Sling System, and improvements persisted through the study. De novo sexual pain is also low after sling surgery.

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

† PISQ-12 has a range from 0-48 with higher scores indicating better sexual function.

PISQ showed statistically significant improvement from baseline to 36 months.

White, A. B., Anger, J. T., Eilber, K., Kahn, B. S., Gonzalez, R. R., & Rosamilia, A. (2021). Female sexual function following sling surgery: A prospective parallel cohort, multi-center study of the Solyx™ single incision sling system versus the Obtryx™ II sling system. Journal of Urology, 206(3), 696-705.

SOLYX DEMONSTRATED STATISTICALLY SIGNIFICANT PATIENT IMPROVEMENT

Solyx improved women’s symptom bother, symptom severity and quality of life.

Following SIS (Solyx) and TMUS (Obtryx II) patients have significant improvement in patient-reported outcomes, including UDI-6, ISI and UIQ-7 at 36 months, indicating disease-specific QoL improvement. Patients have a more positive impression of change in stress UI symptoms at each follow-up visit, indicating generic QoL improvement.

Urogenital Distress Inventory (UDI-6)

Incontinence Severity Index (ISI)

Urinary Impact Questionnaire (UIQ-7)

Patient Global Impression of Improvement (PGI-I)

94.2% of women reported improvement in SUI (PGI-I)

UDI-6, ISI, & UIQ-7 showed statistically significant improvement from baseline to 36 months

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.

Adverse Events

At 36 months, Solyx Single Incision Sling System and Obtryx II Transobturator Mid-Urethral Sling System subjects had similar rates of adverse events, including mesh-related complications, dyspareunia, pelvic pain and urinary retention.

Adverse Events	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 exposure^a	4	2.8%	6	4.3%	0.541
Dyspareunia^b	1	0.7%	0	0.0%	1.000
Mesh Erosion^c	0	0.0%	1	0.7%	0.498
Pelvic Pain^d	1	0.7%	0	0.0%	1.000
Urinary Retention^e	4	2.8%	6	4.3%	0.541

a. Mesh exposure defined as the observation of mesh through the vaginal wall or epithelium.
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 efficacy, improved patient quality of life and improvement in sexual function over the course of 3 years.

Comparison of Two Single Incision Slings on the Vagina in an Ovine Model

Published as a full manuscript in the peer-reviewed American Journal of Obstetrics and Gynecology, this study demonstrated favorable performance in host biochemical and mechanical response of Boston Scientific’s Solyx Single Incision Sling (SIS-A) when compared with Coloplast’s Altis (SIS-B).

Background & Objective

For prolapse repair, meshes with higher porosity and lower structural stiffness have been associated with improved outcomes, but research has not explored the impact of these mesh characteristics for SIS. The study was conducted to compare the host response of two currently available SIS in an animal model — the lower-stiffness, higher-porosity Solyx SIS and the higher-stiffness, lower-porosity Altis SIS.

Results

	Solyx (SIS-A)		Altis (SIS-B)
	Buckled in only 1 specimen (8%, n=1/13, P=0.004)		Consistently buckled (73%, n=8/11)
	Optimal inter-fiber distance and pore size (>1 mm)		Sub-optimal inter-fiber distance and pore size (<1 mm)
	Demonstrated improved tissue integration (73% vs. 27%, P<0.05)		Higher amounts of both collagen I and III, suggesting greater microinjury to surrounding tissue

	Solyx (SIS-A)
	Buckled in only 1 specimen (8%, n=1/13, P=0.004)
	Optimal inter-fiber distance and pore size (>1 mm)
	Demonstrated improved tissue integration (73% vs. 27%, P<0.05)
	Altis (SIS-B)
	Consistently buckled (73%, n=8/11)
	Sub-optimal inter-fiber distance and pore size (<1 mm)
	Higher amounts of both collagen I and III, suggesting greater microinjury to surrounding tissue

Shapiro KK, Knight KM, Liang R, et al. Comparison of two single incision slings on the vagina in an ovine model. Am J Obstet Gynecol. 2020 Jul 21. https://doi.org/10.1016/j.ajog.2020.07.005

Additional Clinical Research

Boston Scientific actively partners with leading researchers in two additional large-scale clinical projects.

Pelvic Floor Disorders Registry (PFDR) – In support with the American Urogynecological Society (AUGS) and other industry partners, Boston Scientific is part of a national patient registry to evaluate the effectiveness, quality of life and safety associated with native tissue repair and mesh repair.

SUPeR study – Boston Scientific has contributed funding to a randomized, blinded study to compare the effectiveness and safety of two transvaginal apical suspension strategies for uterovaginal prolapse. The SUPeR study is conducted by the Pelvic Floor Disorders Network (PFDN), a multi-center network of the National Institute of Child Health and Development (NICHD).

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

25+

years of physician-driven, customer-centric innovation

100+

articles and abstracts

Numerous

ongoing investigator-sponsored research (ISR) studies

$30 million+

in post-market 522 studies and publications

2

additional large-scale clinical projects

3500+

women treated with our products in clinical studies around the world

150+

physicians collaborating on research

100+

clinical studies / publications

14

ongoing investigator-sponsored research (ISR) studies

$32 million

in post-market 522 studies and publications

2

additional large-scale clinical projects

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