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



Status:Completed
Conditions:Urology, Urology
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:4/3/2019
Start Date:June 2013
End Date:January 17, 2018

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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

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 SUI. Safety
information and patient outcomes will be collected for three (3) years and evaluated.


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 MESA

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 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:

1. Neurogenic bladder

2. Urethral stricture and bladder neck contracture

3. Bladder stones or tumors

4. Urinary tract fistula or diverticula

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

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

9. Subjects with diabetes and an A1c ≥ 7%

10. Non-English speaking subjects

11. 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
We found this trial at
23
sites
Fort Worth, Texas 76104
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931 S. 9th Street
Bismarck, North Dakota 58504
701-530-6954
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Bismarck, ND
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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Houston, TX
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Austin, Texas 78701
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Austin, TX
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Beverly Hills, California 90211
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Beverly Hills, CA
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Canton, Georgia 30114
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Canton, GA
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Charlotte, North Carolina 28204
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Charlotte, NC
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Covington, Washington 98042
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Covington, WA
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Dallas, Texas 75390
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Dallas, TX
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Franklin, Tennessee 37067
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Franklin, TN
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Hanover, Maryland 21076
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Hanover, MD
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Irving, Texas 75062
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Irving, TX
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Irving, Texas 75062
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Irving, TX
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11234 Anderson St
Loma Linda, California 92354
(909) 558-4000
Loma Linda University Medical Center An outgrowth of the original Sanitarium on the hill in...
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Loma Linda, CA
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Malvern,
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Nacogdoches, Texas 75965
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Nacogdoches, TX
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Naples, Florida 34105
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Naples, FL
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Newark, Delaware 19718
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Newark, DE
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Norwalk, Connecticut 06856
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Norwalk, CT
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Odessa, TX
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San Diego, California 92130
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San Diego, CA
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Winston-Salem, North Carolina 27103
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Winston-Salem, NC
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800 Forest Ave.
Zanesville, Ohio 43701
(740) 454-5000
Genesis Healthcare System Genesis HealthCare System is an integrated health care delivery system based in...
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Zanesville, OH
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