Solyx: Post Market Study Of Single Incision Sling Versus Transobturator Sling for Stress Urinary Incontinence

• Sponsor: Boston Scientific Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01784588
• Collaborator: (none)
• Enrollment: 281
• Locations: 23
• Arms: 2
• Duration (Months): 55.6
• Patients Per Site: 12.2
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Stress Urinary Incontinence	Device: Solyx Single Incision Sling System; Device: Obtryx II Sling System	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 281 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective, Non-Randomized, 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
• Study Start Date: Jun 1, 2013
• Actual Primary Completion Date: Jan 17, 2018
• Actual Study Completion Date: Jan 17, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Solyx Single Incision Sling System Solyx Single Incision Sling System	Device: Solyx Single Incision Sling System; Solyx Single Incision Sling System
Active Comparator: Obtryx II Sling System Obtryx II Sling System	Device: Obtryx II Sling System; Standard outside-in transobturator sling

Outcome Measures

Primary Outcome Measures

1. Number of Subjects Meeting Definition of Treatment Success at 36 Months, by a Composite of Objective and Subjective Measures [Data presented is for 36 months]

   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").

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Female ≥ 18 years of age

2. Willing and able to comply with the study procedures and provide written informed consent to participate in the study (subject or legal representative)

3. Diagnosed with predominant SUI confirmed by positive cough stress test during the protocol required bladder fill procedure (see manual of operations)

4. Confirmed SUI is greater than urge incontinence with the Medical Epidemiologic Social Aspect (MESA) questionnaire

5. Cystometric capacity ≥ 300 cc

6. Post-void residual (PVR) of ≤ 150 cc

7. Medically approved for general, regional or monitored anesthesia

Exclusion Criteria:

1. Subjects who are pregnant, lactating, or planning future pregnancies

2. Subjects with a chief complaint of overactive bladder

3. 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

4. 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

5. Subjects with prior pelvic organ prolapse surgery who experienced mesh complications

6. Subjects with previous radiation therapy to the pelvis

7. Subjects with known or suspected hypersensitivity to polypropylene mesh

8. Subjects with any of the following confounding conditions:

9. Neurogenic bladder

10. Urethral stricture and bladder neck contracture

11. Bladder stones or tumors

12. Urinary tract fistula or diverticula

13. Pathology which would compromise implant placement including subjects currently taking anticoagulation therapy

14. Pathology that would limit blood supply or infections that would compromise healing including chemotherapy, systemic steroids and systemic immunosuppressants

15. Subjects with diabetes and an A1c ≥ 7%

16. Non-English speaking subjects

17. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cedars Sinai Medical Center	Beverly Hills	California	United States	90211
2	Loma Linda University Medical Center	Loma Linda	California	United States	92354
3	Scripps Clinic Carmel Valley	San Diego	California	United States	92130
4	Norwalk Hospital	Norwalk	Connecticut	United States	06850
5	Christiana Hospital	Newark	Delaware	United States	19713
6	Physicians Regional Healthcare	Naples	Florida	United States	34105
7	Cherokee Women's Health Specialist	Canton	Georgia	United States	30114
8	Chesapeake Urology Research Associates	Hanover	Maryland	United States	21076
9	Novant Health Presbyterian Medical Center	Charlotte	North Carolina	United States	28210
10	Lyndhurst Clinical Research	Winston-Salem	North Carolina	United States	27103
11	St Alexius Medical Center	Bismarck	North Dakota	United States	58501
12	Genesis Healthcare System	Zanesville	Ohio	United States	43701
13	Center for Pelvic Health	Franklin	Tennessee	United States	37067
14	University of Texas Southwestern	Austin	Texas	United States	78701
15	University of Texas, Southwestern	Dallas	Texas	United States	75390
16	Baylor University Medical Center	Fort Worth	Texas	United States	76104
17	Baylor College of Medicine	Houston	Texas	United States	77030
18	Las Colinas OBGYN	Irving	Texas	United States	75062
19	MacArthur OB/GYN Management, LLC	Irving	Texas	United States	75062
20	Kyle P. McMorries, MD	Nacogdoches	Texas	United States	75965
21	Permian Research Foundation	Odessa	Texas	United States	79761
22	Valley Medical Center	Covington	Washington	United States	98055
23	Cabrini Medical Centre	Malvern		Australia

Sponsors and Collaborators

• Boston Scientific Corporation

Investigators

• Principal Investigator: Amanda White, MD, University of Texas
• Principal Investigator: Joseph Schaffer, MD, University of Texas Southwestern Medical Center

Study Documents (Full-Text)

• Study Protocol - Aug 22, 2018
• Statistical Analysis Plan - Feb 21, 2017

More Information

Publications

None provided.

• Responsible Party: Boston Scientific Corporation
• ClinicalTrials.gov Identifier: NCT01784588
• Other Study ID Numbers: U9915-Solyx
• First Posted: Feb 6, 2013
• Last Update Posted: Feb 10, 2021
• Last Verified: Jan 1, 2021

• Additional relevant MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress

Study Results

Participant Flow

Recruitment Details	Subject enrollment began on August 1, 2013 and was completed on December 23, 2014.

Arm/Group Title	Solyx Single Incision Sling System	Obtryx II Sling System
Arm/Group Description	Solyx Single Incision Sling System Solyx Single Incision Sling System: Solyx Single Incision Sling System	Obtryx II Sling System Obtryx II Sling System: Standard outside-in transobturator sling
Period Title: Overall Study
STARTED	141	140
COMPLETED	104	108
NOT COMPLETED	37	32

Baseline Characteristics

Arm/Group Title	Solyx Single Incision Sling System	Obtryx II Sling System	Total
Arm/Group Description	Solyx Single Incision Sling System Solyx Single Incision Sling System: Solyx Single Incision Sling System	Obtryx II Sling System Obtryx II Sling System: Standard outside-in transobturator sling	Total of all reporting groups
Overall Participants	141	140	281
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	49.1 (11.6)	48.9 (11.7)	49.0 (11.6)
Sex: Female, Male (Count of Participants)
Female	141 100%	140 100%	281 100%
Male	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	14 9.9%	35 25%	49 17.4%
Not Hispanic or Latino	127 90.1%	105 75%	232 82.6%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	2 1.4%	4 2.9%	6 2.1%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	11 7.8%	8 5.7%	19 6.8%
White	124 87.9%	123 87.9%	247 87.9%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	4 2.8%	5 3.6%	9 3.2%
Region of Enrollment (participants) [Number]
United States	123 87.2%	140 100%	263 93.6%
Australia	18 12.8%	0 0%	18 6.4%
Body Mass Index (lb/in^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [lb/in^2]	29.6 (7.3)	29.7 (6.3)	29.6 (6.8)
Smoking Status (Count of Participants)
Never	101 71.6%	88 62.9%	189 67.3%
Current	13 9.2%	22 15.7%	35 12.5%
Previous	27 19.1%	30 21.4%	57 20.3%
Unknown	0 0%	0 0%	0 0%
Diabetes (Count of Participants)
None	136 96.5%	128 91.4%	264 94%
Insulin Controlled	2 1.4%	2 1.4%	4 1.4%
Oral Agent Controlled	2 1.4%	6 4.3%	8 2.8%
Diet Controlled	1 0.7%	4 2.9%	5 1.8%
Menopausal Status (Count of Participants)
Premenopausal	72 51.1%	80 57.1%	152 54.1%
Perimenopausal	16 11.3%	12 8.6%	28 10%
Postmenopausal	53 37.6%	48 34.3%	101 35.9%
Current Hormone Replacement Therapy (HRT) (Count of Participants)
None	110 78%	120 85.7%	230 81.9%
Oral Estrogen	11 7.8%	5 3.6%	16 5.7%
Vaginal Estrogen	11 7.8%	8 5.7%	19 6.8%
Combination Replacement Therapy	7 5%	3 2.1%	10 3.6%
Transdermal Estrogen	1 0.7%	0 0%	1 0.4%
Other	1 0.7%	4 2.9%	5 1.8%
Hysterectomy (Count of Participants)
None	101 71.6%	106 75.7%	207 73.7%
Vaginal	13 9.2%	19 13.6%	32 11.4%
Laparotomy	9 6.4%	7 5%	16 5.7%
Laparoscopy	9 6.4%	3 2.1%	12 4.3%
Laparoscopic Assisted Vaginal	7 5%	3 2.1%	10 3.6%
Robotic	2 1.4%	2 1.4%	4 1.4%

Outcome Measures

1. Primary Outcome

Title	Number of Subjects Meeting Definition of Treatment Success at 36 Months, by a Composite of Objective and Subjective Measures
Description	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").
Time Frame	Data presented is for 36 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Solyx Single Incision Sling System	Obtryx II Sling System
Arm/Group Description	Solyx Single Incision Sling System Solyx Single Incision Sling System: Solyx Single Incision Sling System	Obtryx II Sling System Obtryx II Sling System: Standard outside-in transobturator sling
Measure Participants	104	108
Count of Participants [Participants]	94 66.7%	96 68.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Solyx Single Incision Sling System, Obtryx II Sling System
	Comments	Available Cases Only - Intent-to-Treat
	Type of Statistical Test	Non-Inferiority
	Comments	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%.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Adjusted Difference in Percentages
	Estimated Value	-0.4
	Confidence Interval	(2-Sided) 90%; -8.2 to 7.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Solyx Single Incision Sling System, Obtryx II Sling System
	Comments	Available Cases Only - Intent-to-Treat
	Type of Statistical Test	Non-Inferiority
	Comments	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%.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Unadjusted Treatment Difference (%)
	Estimated Value	1.5
	Confidence Interval	(2-Sided) 90%; -5.4 to 8.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	36 Months
Arm/Group Title	Solyx Single Incision Sling System		Obtryx II Sling System
Arm/Group Description	Solyx Single Incision Sling System Solyx Single Incision Sling System: Solyx Single Incision Sling System		Obtryx II Sling System Obtryx II Sling System: Standard outside-in transobturator sling
All Cause Mortality
	Solyx Single Incision Sling System		Obtryx II Sling System
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/141 (0%)		1/140 (0.7%)
Serious Adverse Events
	Solyx Single Incision Sling System		Obtryx II Sling System
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/141 (0.7%)		1/140 (0.7%)
General disorders
Device Extrusion	1/141 (0.7%)	1	1/140 (0.7%)	1
Other (Not Including Serious) Adverse Events
	Solyx Single Incision Sling System		Obtryx II Sling System
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	14/141 (9.9%)		21/140 (15%)
Gastrointestinal disorders
Abdominal Pain	0/141 (0%)	0	1/140 (0.7%)	1
Constipation	0/141 (0%)	0	1/140 (0.7%)	1
General disorders
Sensation of pressure	0/141 (0%)	0	1/140 (0.7%)	1
Device extrusion	3/141 (2.1%)	3	5/140 (3.6%)	5
Medical device site reaction	0/141 (0%)	0	1/140 (0.7%)	1
Infections and infestations
Fungal Infection	0/141 (0%)	0	1/140 (0.7%)	1
Urinary tract infection	2/141 (1.4%)	2	5/140 (3.6%)	9
Vaginal infection	1/141 (0.7%)	1	1/140 (0.7%)	1
Renal and urinary disorders
Atonic urinary bladder	0/141 (0%)	0	1/140 (0.7%)	1
Bladder spasm	1/141 (0.7%)	1	0/140 (0%)	0
Haematuria	1/141 (0.7%)	1	0/140 (0%)	0
Mixed incontinence	0/141 (0%)	0	1/140 (0.7%)	1
Pollakiuria	0/141 (0%)	0	1/140 (0.7%)	1
Stress urinary incontinence	1/141 (0.7%)	1	1/140 (0.7%)	2
Urge incontinence	0/141 (0%)	0	2/140 (1.4%)	2
Urinary incontinence	0/141 (0%)	0	3/140 (2.1%)	3
Urinary retention	4/141 (2.8%)	4	6/140 (4.3%)	6
Reproductive system and breast disorders
Pelvic Pain	1/141 (0.7%)	1	0/140 (0%)	0
Vaginal haemorrhage	2/141 (1.4%)	2	0/140 (0%)	0
Vulvovaginal pain	0/141 (0%)	0	1/140 (0.7%)	1
Dyspareunia	1/141 (0.7%)	1	0/140 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.