Comparison of Efficacy and Side Effects Between the Obtryx and Solyx Band With 5-year Follow-up.

NCT03916471 | Unknown

• 1 other identifier: BOSTON2018
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

Brief Summary

Boston2018 post-market clinical study is a prospective, randomized, non-inferiority study to assess the efficacy and adverse events of the Solyx™ Single Incision Sling (SIS) System compared to the gold-standard Obtryx™ II Sling System, in patients with stress urinary incontinence (SUI) and long-term follow-up (5 years).

Conditions

Stress Urinary Incontinence

Keywords

Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (7)

• Continence rate (Objective) assessed by an effort test

  For the analysis of the objective cure of incontinence, an effort test will be carried out through three strokes of cough, with bladder volume between 200-300 ml in a lithotomy position.

  Month 1

• Continence rate (Objective) assessed by an effort test

  For the analysis of the objective cure of incontinence, an effort test will be carried out through three strokes of cough, with bladder volume between 200-300 ml in a lithotomy position.

  Month 6

• Continence rate (Objective) assessed by an effort test

  For the analysis of the objective cure of incontinence, an effort test will be carried out through three strokes of cough, with bladder volume between 200-300 ml in a lithotomy position.

  Year 1

• Continence rate (Objective) assessed by an effort test

  For the analysis of the objective cure of incontinence, an effort test will be carried out through three strokes of cough, with bladder volume between 200-300 ml in a lithotomy position.

  Year 2

• Continence rate (Objective) assessed by an effort test

  For the analysis of the objective cure of incontinence, an effort test will be carried out through three strokes of cough, with bladder volume between 200-300 ml in a lithotomy position.

  Year 3

• Continence rate (Objective) assessed by an effort test

  For the analysis of the objective cure of incontinence, an effort test will be carried out through three strokes of cough, with bladder volume between 200-300 ml in a lithotomy position.

  Year 4

• Continence rate (Objective) assessed by an effort test

  For the analysis of the objective cure of incontinence, an effort test will be carried out through three strokes of cough, with bladder volume between 200-300 ml in a lithotomy position.

  Year 5

Secondary Outcomes (14)

• Continence rate (Subjective) assessed by Incontinence Questionnaire-Urinary Short Form (ICQ-SF)

  Month 1, month 6, year 1, year 2, year 3, year 4 and year 5.

• Pad test

  Month 1, month 6, year 1, year 2, year 3, year 4 and year 5.

• Patient satisfaction assessed by PGI-I (Patient Global Impression of Improvement)

  Month 1, month 6, year 1, year 2, year 3, year 4 and year 5.

• Patient satisfaction assessed by the "Global Satisfaction Test"

  Month 1, month 6, year 1, year 2, year 3, year 4 and year 5.

• Patient satisfaction assessed by the "Recommendations questionnarie"

  Month 1, month 6, year 1, year 2, year 3, year 4 and year 5.

Study Arms (2)

S (SOLYX)

EXPERIMENTAL

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.

Device: Solyx™ SIS System

O (OBTRYX II)

EXPERIMENTAL

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.

Device: Obtryx™ II System (Halo)

Interventions

Solyx™ SIS System DEVICE

Single-incision sling system

S (SOLYX)

Obtryx™ II System (Halo) DEVICE

Transobturator Mid-urethral Sling System

O (OBTRYX II)

Eligibility Criteria

• Age: 40 Years+
• Gender Eligibility Details: female diagnosed with symtomatic stress urinary incontinence
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients diagnosed with symptomatic stress urinary incontinence candidates for stress-free bands
• Age \> or = 40 years
• informed consent signed by the patient

You may not qualify if:

• patients who are pregnant or wish to become
• patients who need anticoagulant
• active vaginal or urinary infection
• previous surgical interventions for the treatment of incontinence
• body mass index \> 35

Sponsors & Collaborators

• Instituto de Investigacion Sanitaria La Fe: lead

Study Sites (1)

Hospital Universitario y Politécnico La Fe

Valencia, Spain

RECRUITING

Related Publications (11)

• 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.

  PMID: 15758785 BACKGROUND

• 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.

  PMID: 19941278 BACKGROUND

• 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.

  PMID: 12559262 BACKGROUND

• 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.

  PMID: 12861145 BACKGROUND

• 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.

  PMID: 8798092 BACKGROUND

• 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.

  PMID: 17970791 BACKGROUND

• 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.

  PMID: 18535753 BACKGROUND

• 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.

  PMID: 28746980 BACKGROUND

• 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.

  PMID: 26130017 BACKGROUND

• 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.

  PMID: 28756647 BACKGROUND

• 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.

  PMID: 37888839 DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marta Garcia

  Instituto de Investigación y Politécnico La Fe

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Cortell

CONTACT

0034961246711; investigacion_clinica@iislafe.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2019
• First Posted: April 16, 2019
• Study Start: December 21, 2018
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)