Stress Urinary IncontinenceNCT03916471
Comparison of Efficacy and Side Effects Between the Obtryx and Solyx Band With 5-year Follow-up.
A study testing Solyx™ SIS System and Obtryx™ II System (Halo) in people with Stress Urinary Incontinence, run by Instituto de Investigacion Sanitaria La Fe at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Solyx™ SIS System and Obtryx™ II System (Halo)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 siteSpain
- Study dates
- 21 Dec 2018to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients diagnosed with symptomatic stress urinary incontinence candidates for stress-free bands
- Age > or = 40 years
- informed consent signed by the patient
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario y Politécnico La Fe
Valencia
Laura Segura
About this study
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
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).
Read the 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).
- Conditions
- Stress Urinary Incontinence
- Being tested
- Solyx™ SIS System, Obtryx™ II System (Halo)
- Keywords
- Stress Urinary Incontinence
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solyx™ SIS SystemDevice
Single-incision sling system
Obtryx™ II System (Halo)Device
Transobturator Mid-urethral Sling System
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Obtryx™ II System (Halo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Year 5
Secondary outcomes (14)
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.
Measured: 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
Measured: 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".
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Month 1, month 6, year 1, year 2, year 3, year 4 and year 5.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start21 Dec 2018
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigacion Sanitaria La Fe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marta Garcia, Principal investigator, Instituto de Investigación y Politécnico La Fe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03916471
- Sponsor's protocol ID
- BOSTON2018
- Status last verified
- Sep 2023
- First submitted
- 8 Apr 2019
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 15758785Haylen 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.
PubMed 19941278Abrams 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.
PubMed 12559262Yalcin 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.
PubMed 12861145Ulmsten 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.
PubMed 8798092Ward 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.
PubMed 17970791Nilsson 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.
PubMed 18535753Nambiar 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.
PubMed 28746980Ford 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.
PubMed 26130017Ford 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.
PubMed 28756647Carter 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.
PubMed 37888839
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03916471
- Acronym / sponsor ID
- BOSTON2018
- Conditions
- Stress Urinary Incontinence
- Keywords
- Stress Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 166 participants (estimated)
- Lead sponsor
- Instituto de Investigacion Sanitaria La FeUniversity, hospital or other
- Study start
- 21 Dec 2018 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 16 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| S (SOLYX) | Experimental | Device: Solyx™ SIS SystemThe 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. |
| O (OBTRYX II) | Experimental | Device: Obtryx™ II System (Halo)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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients diagnosed with symptomatic stress urinary incontinence candidates for stress-free bands
- Age > or = 40 years
- informed consent signed by the patient
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Solyx™ SIS SystemSingle-incision sling system | Device | S (SOLYX) |
| Obtryx™ II System (Halo)Transobturator Mid-urethral Sling System | Device | O (OBTRYX II) |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
14 secondary outcomes
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.
Pad test
Time frame: 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)
Time frame: Month 1, month 6, year 1, year 2, year 3, year 4 and year 5.
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.
Patient satisfaction assessed by the "Recommendations questionnarie"
Time frame: 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)
Time frame: 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 )
Time frame: Month 1, month 6, year 1, year 2, year 3, year 4 and year 5.
Early complications assessed by Post-Mictional Residue
Time frame: 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)
Time frame: 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)
Time frame: Month 1, month 6, year 1, year 2, year 3, year 4 and year 5.
Early complications assessed by VAS (Visual Analogue Scale)
Time frame: Day 0, 7-10 days after the intervention, Month 1
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.
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.
Long term complications assessed by "Emptying dysfunction"
Time frame: Month 1, month 6, year 1, year 2, year 3, year 4 and year 5.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Background: PubMed 15758785Thom 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.
- Background: PubMed 19941278Haylen 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.
- Background: PubMed 12559262Abrams 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.
- Background: PubMed 12861145Yalcin 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.
- Background: PubMed 8798092Ulmsten 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.
- Background: PubMed 17970791Ward 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.
- Background: PubMed 18535753Nilsson 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.
- Background: PubMed 28746980Nambiar 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.
- Background: PubMed 26130017Ford 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.
- Background: PubMed 28756647Ford 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.
- Derived from this study: PubMed 37888839Carter 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.
- Individual participant dataSharing planned: No
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RecruitingObservational study
Standardized 4D Transperineal Ultrasound Assessment of Urethrovesical Junction Mobility After Vaginal Laser Treatment for Stress Urinary Incontinence.
Urinary Incontinence , Stress, Laser Therapy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marta Garcia principal investigator
Instituto de Investigación y Politécnico La Fe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Solyx™ SIS System and Obtryx™ II System (Halo) in people with Stress Urinary Incontinence, run by Instituto de Investigacion Sanitaria La Fe at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Cortell (0034961246711, investigacion_clinica@iislafe.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Continence rate (Objective) assessed by an effort test (time frame: Month 1). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03916471, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.