Clinical trial NCT03916471: Comparison of Efficacy and Side Effects Between the Obtryx and Solyx Band With 5-year Follow-up.
Official title: Comparison of Efficacy and Side Effects Between the Obtryx and Solyx Band With 5-year Follow-up. Prospective, Randomized and Non-inferiority Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stress Urinary Incontinence
Keywords: Stress Urinary Incontinence
Lead sponsor: Instituto de Investigacion Sanitaria La Fe
Sponsor class: OTHER
First posted: 2019-04-16
Enrollment: 166
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Detailed description: Randomized prospective non-inferiority study, in which we evaluate patients with stress urinary incontinence (SUI) who undergo surgical treatment consisting of a minimal incision in the suburethral area of the vaginal mucosa for a mesh insertion in order to:

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).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Continence rate (Objective) assessed by an effort test
timeFrame: Month 1
measure: Continence rate (Objective) assessed by an effort test
timeFrame: Month 6
measure: Continence rate (Objective) assessed by an effort test
timeFrame: Year 1
measure: Continence rate (Objective) assessed by an effort test
timeFrame: Year 2
measure: Continence rate (Objective) assessed by an effort test
timeFrame: Year 3
measure: Continence rate (Objective) assessed by an effort test
timeFrame: Year 4
measure: Continence rate (Objective) assessed by an effort test
timeFrame: Year 5
Secondary outcomes:
measure: Continence rate (Subjective) assessed by Incontinence Questionnaire-Urinary Short Form (ICQ-SF)
timeFrame: Month 1, month 6, year 1, year 2, year 3, year 4 and year 5.
measure: Pad test
timeFrame: Month 1, month 6, year 1, year 2, year 3, year 4 and year 5.
measure: Patient satisfaction assessed by PGI-I (Patient Global Impression of Improvement)
timeFrame: Month 1, month 6, year 1, year 2, year 3, year 4 and year 5.
measure: Patient satisfaction assessed by the "Global Satisfaction Test"
timeFrame: Month 1, month 6, year 1, year 2, year 3, year 4 and year 5.
measure: Patient satisfaction assessed by the "Recommendations questionnarie"
timeFrame: Month 1, month 6, year 1, year 2, year 3, year 4 and year 5.
measure: Evaluation of life quality improvement assessed by I-QoL questionnaire (Urinary Incontinence-Specific Quality of Life Instrument)
timeFrame: Month 1, month 6, year 1, year 2, year 3, year 4 and year 5.
measure: Evaluation of sexual life, assessed by PSIQ 12 questionnaire (Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire )
timeFrame: Month 1, month 6, year 1, year 2, year 3, year 4 and year 5.
measure: Early complications assessed by Post-Mictional Residue
timeFrame: Day 0, 7-10 days after the intervention, Month 1
measure: Early complications assessed by OAB-q questionnaire (Overactive Bladder symptom and health-related quality of life questionnaire)
timeFrame: Day 0, 7-10 days after the intervention, Month 1
measure: Long term complications assessed by OAB-q questionnaire (Overactive Bladder symptom and health-related quality of life questionnaire)
timeFrame: Month 1, month 6, year 1, year 2, year 3, year 4 and year 5.
measure: Early complications assessed by VAS (Visual Analogue Scale)
timeFrame: Day 0, 7-10 days after the intervention, Month 1
measure: Long term complications assessed by "Extrusion" (integrity of the vaginal mucus)
timeFrame: Month 1, month 6, year 1, year 2, year 3, year 4 and year 5.
measure: Long term complications assessed by emergence of recurrent urinary tract infections (UTIs)
timeFrame: Month 1, month 6, year 1, year 2, year 3, year 4 and year 5.
measure: Long term complications assessed by "Emptying dysfunction"
timeFrame: Month 1, month 6, year 1, year 2, year 3, year 4 and year 5.
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Hospital Universitario y Politécnico La Fe
Study officials:
affiliation: Instituto de Investigación y Politécnico La Fe
name: Marta Garcia
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.