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

Study Overview
=================
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).

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

Conditions
-----------------
Stress Urinary Incontinence

Intervention / Treatment
-----------------
* Device: Solyx™ SIS System
* Device: Obtryx™ II System (Halo)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: S (SOLYX)<br>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<br>* Single-incision sling system<br>|
| Experimental: O (OBTRYX II)<br>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)<br>* Transobturator Mid-urethral Sling System<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Continence rate (Subjective) assessed by Incontinence Questionnaire-Urinary Short Form (ICQ-SF) | Incontinence Questionnaire-Urinary Short Form (ICQ-SF): continent patient when the reduction is equal to or greater than 50% of the value prior to the intervention. | Month 1, month 6, year 1, year 2, year 3, year 4 and year 5. | 
| Pad test | 1 hour pad test: After a spontaneous urination the patient will place a compress that will be weighed previously. After, the patient has to drink a half liter of water in 15 minutes sitting. Between the minute 15 to 45 has to walk and / or go up / down stairs. From minute 45-60 the patient has to get up and sit 10 times, cough 10 times, run 1 minute, lift an object from the ground 10 times and washes his/her hands 1 minute. According to the difference in weight of the compress, it will be cataloged as follows: ≤ 1 gram -> continent. 1.1-9.9 grams -> mild incontinence. 10-49.9 grams -> moderate incontinence. > 50 grams -> severe incontinence | 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) | PGI-I consider a patient satisfied when the patient answer  better or much better. | Month 1, month 6, year 1, year 2, year 3, year 4 and year 5. | 
| Patient satisfaction assessed by the Global Satisfaction Test | Global satisfaction assessment will be required, with a rank 1-5, being 1 very satisfied and 5 very dissatisfied. | Month 1, month 6, year 1, year 2, year 3, year 4 and year 5. | 
| Patient satisfaction assessed by the Recommendations questionnarie | The recommendation grade will be assessed through the question will you recommend this surgical treatment for other patients?, the possible answer are Yes or No. | Month 1, month 6, year 1, year 2, year 3, year 4 and year 5. | 
| Evaluation of life quality improvement assessed by I-QoL questionnaire (Urinary Incontinence-Specific Quality of Life Instrument) | To assess the life quality impact, I-QoL questionnaire (Urinary Incontinence-Specific Quality of Life Instrument) will be used , this questionnaire, is composed by 22 items. The highest punctuation mean better life quality. The modification of 2.5 points, which has been considered in this questionnaire, is the minimum clinically significant modification in patients presenting SUI. This questionnaire is validated in Spanish. | Month 1, month 6, year 1, year 2, year 3, year 4 and year 5. | 
| Evaluation of sexual life, assessed by PSIQ 12 questionnaire (Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire ) | To assess the impact on sexual life, the PSIQ 12 questionnaire (Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire ) will be used. It is composed of 12 items graded from never to always. This questionnaire is validated in heterosexual women who have urinary incontinence and / or pelvic organ prolapse. Scores are calculated for each item with a value of always = 0 and for never = 4. It is used inversely in items 1-4. | Month 1, month 6, year 1, year 2, year 3, year 4 and year 5. | 
| Early complications assessed by Post-Mictional Residue | Are considered by the urgency of urination, the inability to void, the presence of PMR greater than 50% of the total volume after spontaneous voiding or the presence of pain that prevents ambulation, in the first 30 days after the intervention. For the elevated PMR assessment, perineal ultrasound measurement will be carried out after spontaneous micturition. If the PMR measurement will be higher or equal, probing would be performed to obtain the exact residue. If it is pathological, proceed according to the usual practice. | Day 0, 7-10 days after the intervention, Month 1 | 
| Early complications assessed by OAB-q questionnaire (Overactive Bladder symptom and health-related quality of life questionnaire) | OAB-q questionnaire (Overactive Bladder symptom and health-related quality of life questionnaire). Individual answer punctuation: lowest 0, highest 5 .If the score ≥8 will proceed according to the usual practice. | Day 0, 7-10 days after the intervention, Month 1 | 
| Long term complications assessed by OAB-q questionnaire (Overactive Bladder symptom and health-related quality of life questionnaire) | OAB-q questionnaire (Overactive Bladder symptom and health-related quality of life questionnaire). Individual answer punctuation: lowest 0, highest 5 .If the score ≥8 will proceed according to the usual practice. | Month 1, month 6, year 1, year 2, year 3, year 4 and year 5. | 
| Early complications assessed by VAS (Visual Analogue Scale) | Only when the patient has a pain that prevents ambulation. VAS: Pain scale for quantification of pain. Range 0 to 10. 0: No pain 5: Distressing pain 10: Unbearable pain | Day 0, 7-10 days after the intervention, Month 1 | 
| Long term complications assessed by Extrusion (integrity of the vaginal mucus) | Extrusion: The integrity of the vaginal mucus will be checked in all the visits that are made. If there is evidence of mesh extrusion, it is classified as asymptomatic / symptomatic and according to its size (greater or less than 1 cm). | Month 1, month 6, year 1, year 2, year 3, year 4 and year 5. | 
| Long term complications assessed by emergence of recurrent urinary tract infections (UTIs) | Urinary tract infection: in the presence of at least 1 monthly urinary tract infections (UTI), the patient will be considered to have developed repeat UTIs. | Month 1, month 6, year 1, year 2, year 3, year 4 and year 5. | 
| Long term complications assessed by Emptying dysfunction | Persistent urinary retention at 30 days will be considered as a long term complication. | Month 1, month 6, year 1, year 2, year 3, year 4 and year 5. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stress Urinary Incontinence