Comparison of Efficacy and Side Effects Between the Obtryx and Solyx Band With 5-year Follow-up.
NCT ID: NCT03916471
Last Updated: 2023-09-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
166 participants
INTERVENTIONAL
2018-12-21
2025-01-01
Brief Summary
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Detailed Description
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Main Objective:
To compare the continence rate (objective) between Solyx and Obtryx II meshes in patients with SUI. This rate will be determined by an effort test.
Secondary Objectives:
* To compare the continence rate (subjective) between both meshes.
* To compare variations in Pad-Test.
* To asses patient satisfaction.
* To evaluate both techniques regarding quality and sexual life modifications.
* To compare both techniques regarding early complications (up to 30 days post implantation).
* To compare the appearance and persistence of late complications (from 30 days onwards).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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S (SOLYX)
The Solyx™SIS System is an innovative mid-urethral sling single incision system consisting of a 9 cm long polypropylene mesh, whose mid-urethral portion (4 cm) is detanged to potentially resist deformation and to reduce irritation to the urethral wall. Snap-fit to delivery device tip allows for advanced placement control and, therefore, the tensioning through the forward and reverse functions performed with this delivery device.
Solyx™ SIS System
Single-incision sling system
O (OBTRYX II)
The Obtryx II System (Halo) is a transobturator sling designed to allow inter-operative adjustability with minimal tissue disruption. It consists of two delivery devices (one patient right and one patient left) and one mesh assembly. The mesh assembly is comprised of a polypropylene knitted mesh with dilator legs and a center tab. At the distal ends of the dilator legs there are association loops designed to be placed in the needle slot of the distal end of the delivery device. The disposable delivery device consists of a handle with a stainless steel needle. The needle is designed to facilitate the passage of the mesh assembly through bodily tissues for placement through the obturator foramen.
Obtryx™ II System (Halo)
Transobturator Mid-urethral Sling System
Interventions
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Solyx™ SIS System
Single-incision sling system
Obtryx™ II System (Halo)
Transobturator Mid-urethral Sling System
Eligibility Criteria
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Inclusion Criteria
* Age \> or = 40 years
* informed consent signed by the patient
Exclusion Criteria
* patients who need anticoagulant
* active vaginal or urinary infection
* previous surgical interventions for the treatment of incontinence
* body mass index \> 35
40 Years
FEMALE
No
Sponsors
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Instituto de Investigacion Sanitaria La Fe
OTHER
Responsible Party
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Principal Investigators
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Marta Garcia
Role: PRINCIPAL_INVESTIGATOR
Instituto de Investigación y Politécnico La Fe
Locations
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Hospital Universitario y Politécnico La Fe
Valencia, , Spain
Countries
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Central Contacts
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Facility Contacts
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Laura Segura
Role: primary
References
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Thom DH, Nygaard IE, Calhoun EA. Urologic diseases in America project: urinary incontinence in women-national trends in hospitalizations, office visits, treatment and economic impact. J Urol. 2005 Apr;173(4):1295-301. doi: 10.1097/01.ju.0000155679.77895.cb.
Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, Monga A, Petri E, Rizk DE, Sand PK, Schaer GN; International Urogynecological Association; International Continence Society. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Neurourol Urodyn. 2010;29(1):4-20. doi: 10.1002/nau.20798.
Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, Van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-Committee of the International Continence Society. The standardisation of terminology in lower urinary tract function: report from the standardisation sub-committee of the International Continence Society. Urology. 2003 Jan;61(1):37-49. doi: 10.1016/s0090-4295(02)02243-4. No abstract available.
Yalcin I, Bump RC. Validation of two global impression questionnaires for incontinence. Am J Obstet Gynecol. 2003 Jul;189(1):98-101. doi: 10.1067/mob.2003.379.
Ulmsten U, Henriksson L, Johnson P, Varhos G. An ambulatory surgical procedure under local anesthesia for treatment of female urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 1996;7(2):81-5; discussion 85-6. doi: 10.1007/BF01902378.
Ward KL, Hilton P; UK and Ireland TVT Trial Group. Tension-free vaginal tape versus colposuspension for primary urodynamic stress incontinence: 5-year follow up. BJOG. 2008 Jan;115(2):226-33. doi: 10.1111/j.1471-0528.2007.01548.x. Epub 2007 Oct 25.
Nilsson CG, Palva K, Rezapour M, Falconer C. Eleven years prospective follow-up of the tension-free vaginal tape procedure for treatment of stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Aug;19(8):1043-7. doi: 10.1007/s00192-008-0666-z. Epub 2008 Jun 6.
Nambiar A, Cody JD, Jeffery ST, Aluko P. Single-incision sling operations for urinary incontinence in women. Cochrane Database Syst Rev. 2017 Jul 26;7(7):CD008709. doi: 10.1002/14651858.CD008709.pub3.
Ford AA, Rogerson L, Cody JD, Ogah J. Mid-urethral sling operations for stress urinary incontinence in women. Cochrane Database Syst Rev. 2015 Jul 1;(7):CD006375. doi: 10.1002/14651858.CD006375.pub3.
Ford AA, Rogerson L, Cody JD, Aluko P, Ogah JA. Mid-urethral sling operations for stress urinary incontinence in women. Cochrane Database Syst Rev. 2017 Jul 31;7(7):CD006375. doi: 10.1002/14651858.CD006375.pub4.
Carter E, Johnson EE, Still M, Al-Assaf AS, Bryant A, Aluko P, Jeffery ST, Nambiar A. Single-incision sling operations for urinary incontinence in women. Cochrane Database Syst Rev. 2023 Oct 27;10(10):CD008709. doi: 10.1002/14651858.CD008709.pub4.
Other Identifiers
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BOSTON2018
Identifier Type: -
Identifier Source: org_study_id
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