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

• ClinicalTrials.gov Identifier: NCT03916471
• Recruitment Status: Recruiting
• First Posted: April 16, 2019
• Last Update Posted: June 11, 2020
• Sponsor: Instituto de Investigacion Sanitaria La Fe
• Information provided by (Responsible Party): Instituto de Investigacion Sanitaria La Fe

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Stress Urinary Incontinence	Device: Solyx™ SIS System; Device: Obtryx™ II System (Halo)	Not Applicable

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).

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 166 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: December 21, 2018
• Estimated Primary Completion Date: January 1, 2025
• Estimated Study Completion Date: January 1, 2025

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Device: Solyx™ SIS System; Single-incision sling system
Experimental: 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.	Device: Obtryx™ II System (Halo); Transobturator Mid-urethral Sling System

Outcome Measures

Primary Outcome Measures :

1. Continence rate (Objective) assessed by an effort test [ Time Frame: Month 1 ]
   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.
2. Continence rate (Objective) assessed by an effort test [ Time Frame: Month 6 ]
   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.
3. Continence rate (Objective) assessed by an effort test [ Time Frame: Year 1 ]
   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.
4. Continence rate (Objective) assessed by an effort test [ Time Frame: Year 2 ]
   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.
5. Continence rate (Objective) assessed by an effort test [ Time Frame: Year 3 ]
   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.
6. Continence rate (Objective) assessed by an effort test [ Time Frame: Year 4 ]
   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.
7. Continence rate (Objective) assessed by an effort test [ Time Frame: Year 5 ]
   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.

Secondary Outcome Measures :

1. Continence rate (Subjective) assessed by Incontinence Questionnaire-Urinary Short Form (ICQ-SF) [ Time Frame: Month 1, month 6, year 1, year 2, year 3, year 4 and year 5. ]
   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.
2. Pad test [ Time Frame: Month 1, month 6, year 1, year 2, year 3, year 4 and year 5. ]

   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

3. Patient satisfaction assessed by PGI-I (Patient Global Impression of Improvement) [ Time Frame: Month 1, month 6, year 1, year 2, year 3, year 4 and year 5. ]
   PGI-I consider a patient satisfied when the patient answer " better or much better".
4. Patient satisfaction assessed by the "Global Satisfaction Test" [ Time Frame: Month 1, month 6, year 1, year 2, year 3, year 4 and year 5. ]
   Global satisfaction assessment will be required, with a rank 1-5, being 1 very satisfied and 5 very dissatisfied.
5. Patient satisfaction assessed by the "Recommendations questionnarie" [ Time Frame: Month 1, month 6, year 1, year 2, year 3, year 4 and year 5. ]
   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.
6. Evaluation of life quality improvement assessed by I-QoL questionnaire (Urinary Incontinence-Specific Quality of Life Instrument) [ Time Frame: Month 1, month 6, year 1, year 2, year 3, year 4 and year 5. ]
   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.
7. Evaluation of sexual life, assessed by PSIQ 12 questionnaire (Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire ) [ Time Frame: Month 1, month 6, year 1, year 2, year 3, year 4 and year 5. ]
   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.
8. Early complications assessed by Post-Mictional Residue [ Time Frame: Day 0, 7-10 days after the intervention, Month 1 ]

   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.

9. Early complications assessed by OAB-q questionnaire (Overactive Bladder symptom and health-related quality of life questionnaire) [ Time Frame: Day 0, 7-10 days after the intervention, Month 1 ]
   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.
10. Long term complications assessed by OAB-q questionnaire (Overactive Bladder symptom and health-related quality of life questionnaire) [ Time Frame: Month 1, month 6, year 1, year 2, year 3, year 4 and year 5. ]
    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.
11. Early complications assessed by VAS (Visual Analogue Scale) [ Time Frame: Day 0, 7-10 days after the intervention, Month 1 ]
    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
12. Long term complications assessed by "Extrusion" (integrity of the vaginal mucus) [ Time Frame: Month 1, month 6, year 1, year 2, year 3, year 4 and year 5. ]
    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).
13. Long term complications assessed by emergence of recurrent urinary tract infections (UTIs) [ Time Frame: Month 1, month 6, year 1, year 2, year 3, year 4 and year 5. ]
    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.
14. Long term complications assessed by "Emptying dysfunction" [ Time Frame: Month 1, month 6, year 1, year 2, year 3, year 4 and year 5. ]
    Persistent urinary retention at 30 days will be considered as a long term complication.

Eligibility Criteria

• Ages Eligible for Study: 40 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: female diagnosed with symtomatic stress urinary incontinence
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Maria Cortell; 0034961246711; investigacion_clinica@iislafe.es

Locations

Spain

Hospital Universitario y Politécnico La Fe; Recruiting

Valencia, Spain

Contact: Laura Segura

Sponsors and Collaborators

Instituto de Investigacion Sanitaria La Fe

Investigators

• Principal Investigator: Marta Garcia; Instituto de Investigación y Politécnico La Fe

More Information

Publications:

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.

• Responsible Party: Instituto de Investigacion Sanitaria La Fe
• ClinicalTrials.gov Identifier: NCT03916471
• Other Study ID Numbers: BOSTON2018
• First Posted: April 16, 2019
• Last Update Posted: June 11, 2020
• Last Verified: June 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Instituto de Investigacion Sanitaria La Fe:

Stress Urinary Incontinence

Additional relevant MeSH terms:

Urinary Incontinence; Enuresis; Urinary Incontinence, Stress; Urination Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Behavioral Symptoms; Elimination Disorders; Mental Disorders