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 effectiveness 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, an approach considered one of the gold standards for the treatment of stress urinary incontinence (SUI).
281 patients, 21 sites, 2 countries, 25 implanters
 

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

The Solyx System met the primary endpoint validating that the single-incision sling is non-inferior to the transobturator device in effectiveness 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%
 
 

SOLYX DEMONSTRATED 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)

Urogenital Distress Inventory (UDI-6)

Incontinence Severity Index (ISI)

Incontinence Severity Index (ISI)

Urinary Impact Questionnaire (UIQ-7)

Urogenital Distress Inventory (UDI-6)

Patient Global Impression of Improvement (PGI-I)

Patient Global Impression of Improvement (PGI-I)
 
 

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

Pelvic Impact Sexual Questionnaire (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.
 
 

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 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
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.

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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.

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

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).
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