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The purpose of this research study is to compare the treatment device (Solyx) to a different mesh sling or control device (Obtryx II) for the treatment of symptoms for Stress Urinary Incontinence (SUI). Safety information and patient outcomes will be collected for three (3) years and evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Solyx Single Incision Sling System | Active Comparator | Solyx Single Incision Sling System |
|
| Obtryx II Sling System | Active Comparator | Obtryx II Sling System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Solyx Single Incision Sling System | Device | Solyx Single Incision Sling System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Meeting Definition of Treatment Success at 36 Months, by a Composite of Objective and Subjective Measures | 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"). | Data presented is for 36 months |
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Inclusion Criteria:
Exclusion Criteria:
Subjects who are pregnant, lactating, or planning future pregnancies
Subjects with a chief complaint of overactive bladder
Subjects with a pattern of recurrent urinary tract infections, defined as ≥ 2 culture-proven urinary tract infections during a 6-month period prior to surgery or ≥ 3 in a 12-month period
Subjects with previous surgical procedures for SUI including bulking, urethral sling, bone anchor, Burch procedure, pubo-vaginal sling, and Marshall-Marchetti-Krantz (MMK) procedure. Excluding Kelly plication, Botox, anterior repair, or Inter-Stim
Subjects with prior pelvic organ prolapse surgery who experienced mesh complications
Subjects with previous radiation therapy to the pelvis
Subjects with known or suspected hypersensitivity to polypropylene mesh
Subjects with any of the following confounding conditions:
Subjects with diabetes and an A1c ≥ 7%
Non-English speaking subjects
Subjects who have participated in an investigational study (medical device or drug) within 30 days of study entry that may impact analysis of this device or have previously participated in the current study
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| Name | Affiliation | Role |
|---|---|---|
| Amanda White, MD | University of Texas | Principal Investigator |
| Joseph Schaffer, MD | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars Sinai Medical Center | Beverly Hills | California | 90211 | United States | ||
| Loma Linda University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33955778 | Derived | White AB, Anger JT, Eilber K, Kahn BS, Gonzalez RR, Rosamilia A. 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. J Urol. 2021 Sep;206(3):696-705. doi: 10.1097/JU.0000000000001830. Epub 2021 May 6. |
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Subject enrollment began on August 1, 2013 and was completed on December 23, 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | Solyx Single Incision Sling System | Solyx Single Incision Sling System Solyx Single Incision Sling System: Solyx Single Incision Sling System |
| FG001 | Obtryx II Sling System | Obtryx II Sling System Obtryx II Sling System: Standard outside-in transobturator sling |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 22, 2018 | May 6, 2019 |
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| Obtryx II Sling System | Device | Standard outside-in transobturator sling |
|
| Loma Linda |
| California |
| 92354 |
| United States |
| Scripps Clinic Carmel Valley | San Diego | California | 92130 | United States |
| Norwalk Hospital | Norwalk | Connecticut | 06850 | United States |
| Christiana Hospital | Newark | Delaware | 19713 | United States |
| Physicians Regional Healthcare | Naples | Florida | 34105 | United States |
| Cherokee Women's Health Specialist | Canton | Georgia | 30114 | United States |
| Chesapeake Urology Research Associates | Hanover | Maryland | 21076 | United States |
| Novant Health Presbyterian Medical Center | Charlotte | North Carolina | 28210 | United States |
| Lyndhurst Clinical Research | Winston-Salem | North Carolina | 27103 | United States |
| St Alexius Medical Center | Bismarck | North Dakota | 58501 | United States |
| Genesis Healthcare System | Zanesville | Ohio | 43701 | United States |
| Center for Pelvic Health | Franklin | Tennessee | 37067 | United States |
| University of Texas Southwestern | Austin | Texas | 78701 | United States |
| University of Texas, Southwestern | Dallas | Texas | 75390 | United States |
| Baylor University Medical Center | Fort Worth | Texas | 76104 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Las Colinas OBGYN | Irving | Texas | 75062 | United States |
| MacArthur OB/GYN Management, LLC | Irving | Texas | 75062 | United States |
| Kyle P. McMorries, MD | Nacogdoches | Texas | 75965 | United States |
| Permian Research Foundation | Odessa | Texas | 79761 | United States |
| Valley Medical Center | Covington | Washington | 98055 | United States |
| Cabrini Medical Centre | Malvern | Australia |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Solyx Single Incision Sling System | Solyx Single Incision Sling System Solyx Single Incision Sling System: Solyx Single Incision Sling System |
| BG001 | Obtryx II Sling System | Obtryx II Sling System Obtryx II Sling System: Standard outside-in transobturator sling |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Body Mass Index | Mean | Standard Deviation | lb/in^2 |
| |||||||||||||||
| Smoking Status | Count of Participants | Participants |
| ||||||||||||||||
| Diabetes | Count of Participants | Participants |
| ||||||||||||||||
| Menopausal Status | Count of Participants | Participants |
| ||||||||||||||||
| Current Hormone Replacement Therapy (HRT) | Count of Participants | Participants |
| ||||||||||||||||
| Hysterectomy | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects Meeting Definition of Treatment Success at 36 Months, by a Composite of Objective and Subjective Measures | 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"). | Posted | Count of Participants | Participants | Data presented is for 36 months |
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|
|
36 Months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Solyx Single Incision Sling System | Solyx Single Incision Sling System Solyx Single Incision Sling System: Solyx Single Incision Sling System | 0 | 141 | 1 | 141 | 14 | 141 |
| EG001 | Obtryx II Sling System | Obtryx II Sling System Obtryx II Sling System: Standard outside-in transobturator sling | 1 | 140 | 1 | 140 | 21 | 140 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Device Extrusion | General disorders | Systematic Assessment | Mesh Extrusion |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Atonic urinary bladder | Renal and urinary disorders | Systematic Assessment |
| ||
| Bladder spasm | Renal and urinary disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Fungal Infection | Infections and infestations | Systematic Assessment |
| ||
| Haematuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Mixed incontinence | Renal and urinary disorders | Systematic Assessment |
| ||
| Pelvic Pain | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Pollakiuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Sensation of pressure | General disorders | Systematic Assessment |
| ||
| Stress urinary incontinence | Renal and urinary disorders | Systematic Assessment |
| ||
| Urge incontinence | Renal and urinary disorders | Systematic Assessment |
| ||
| Urinary incontinence | Renal and urinary disorders | Systematic Assessment |
| ||
| Urinary retention | Renal and urinary disorders | Systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Vaginal haemorrhage | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Vaginal infection | Infections and infestations | Systematic Assessment |
| ||
| Vulvovaginal pain | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Device extrusion | General disorders | Systematic Assessment | Mesh extrusion |
| |
| Medical device site reaction | General disorders | Systematic Assessment | Mesh exposure |
| |
| Dyspareunia | Reproductive system and breast disorders | Systematic Assessment |
|
Before publishing, Institution and Investigator shall submit copies of any proposed publication or presentation to Boston Scientific Corporation (BSC) for review at least 60 days in advance of submission for publication or presentation to a publisher or other third party. BSC reserves the right to delete any Confidential Information or other proprietary information of BSC (including trade secrets but not including Results) from the proposed publication or presentation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Teresa Takle-Flach | Boston Scientific | 952-930-6000 | Teresa.Takle-Flach@bsci.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 21, 2017 | May 6, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Australia |
|
| Current |
|
| Previous |
|
| Unknown |
|
| Insulin Controlled |
|
| Oral Agent Controlled |
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| Diet Controlled |
|
| Perimenopausal |
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| Postmenopausal |
|
| Oral Estrogen |
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| Vaginal Estrogen |
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| Combination Replacement Therapy |
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| Transdermal Estrogen |
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| Other |
|
| Vaginal |
|
| Laparotomy |
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| Laparoscopy |
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| Laparoscopic Assisted Vaginal |
|
| Robotic |
|
| Available Cases Only - Intent-to-Treat | Non-inferiority was evaluated using a two-sided 90% confidence interval (CI) for the treatment difference (SIS minus TMUS). The CI was calculated based on the pooling of treatment differences across propensity score strata for a binary endpoint. | Unadjusted Treatment Difference (%) | 1.5 | 2-Sided | 90 | -5.4 | 8.4 | Non-Inferiority | Non-inferiority (NI) was demonstrated if the entire confidence interval was above -15% at 36 months. The sample size was estimated under the assumption that the proportion of subjects with treatment success is 85% for each of Solyx and Obtryx. For a (one-sided) type I error rate of 0.05, 194 subjects (97 per arm) are needed to have 90% power to demonstrate non-inferiority of Solyx with a NI margin of 15%. |