Stress Urinary IncontinenceSolyxNCT01784588
Post Market Study Of Single Incision Sling Versus Transobturator Sling for Stress Urinary Incontinence
A study testing Solyx Single Incision Sling System and Obtryx II Sling System in people with Stress Urinary Incontinence, run by Boston Scientific Corporation at 23 sites in 2 countries.
Trial summary
The purpose of this research study is to compare the treatment device (Solyx) to a different mesh sling or control device (Obtryx II) for the treatment of symptoms for Stress Urinary Incontinence (SUI). Safety information and patient outcomes will be collected for three (3) years and evaluated. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Solyx Single Incision Sling System and Obtryx II Sling System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 281 participants
- Where
- 23 sitesin 2 countries
- Study dates
- Jun 2013to 17 Jan 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female ≥ 18 years of age
- Willing and able to comply with the study procedures and provide written informed consent to participate in the study (subject or legal representative)
- Diagnosed with predominant SUI confirmed by positive cough stress test during the protocol required bladder fill procedure (see manual of operations)
- Confirmed SUI is greater than urge incontinence with the Medical Epidemiologic Social Aspect (MESA) questionnaire
- Cystometric capacity ≥ 300 cc
- Post-void residual (PVR) of ≤ 150 cc
- Medically approved for general, regional or monitored anesthesia
Who cannot join
- Subjects who are pregnant, lactating, or planning future pregnancies
- Subjects with a chief complaint of overactive bladder
- Subjects with a pattern of recurrent urinary tract infections, defined as ≥ 2 culture-proven urinary tract infections during a 6-month period prior to surgery or ≥ 3 in a 12-month period
- Subjects with previous surgical procedures for SUI including bulking, urethral sling, bone anchor, Burch procedure, pubo-vaginal sling, and Marshall-Marchetti-Krantz (MMK) procedure. Excluding Kelly plication, Botox, anterior repair, or Inter-Stim
- Subjects with prior pelvic organ prolapse surgery who experienced mesh complications
- Subjects with previous radiation therapy to the pelvis
Show all 17Show fewer
- Subjects with known or suspected hypersensitivity to polypropylene mesh
- Subjects with any of the following confounding conditions:
- Neurogenic bladder
- Urethral stricture and bladder neck contracture
- Bladder stones or tumors
- Urinary tract fistula or diverticula
- Pathology which would compromise implant placement including subjects currently taking anticoagulation therapy
- Pathology that would limit blood supply or infections that would compromise healing including chemotherapy, systemic steroids and systemic immunosuppressants
- Subjects with diabetes and an A1c ≥ 7%
- Non-English speaking subjects
- Subjects who have participated in an investigational study (medical device or drug) within 30 days of study entry that may impact analysis of this device or have previously participated in the current study
Trial locations and contacts
23 sites in 2 countries.
23 sites in 2 countries
United States22 sites
University of Texas Southwestern
Austin, Texas, 78701
Cedars Sinai Medical Center
Beverly Hills, California, 90211
St Alexius Medical Center
Bismarck, North Dakota, 58501
Cherokee Women's Health Specialist
Canton, Georgia, 30114
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, 28210
Valley Medical Center
Covington, Washington, 98055
University of Texas, Southwestern
Dallas, Texas, 75390
Baylor University Medical Center
Fort Worth, Texas, 76104
Center for Pelvic Health
Franklin, Tennessee, 37067
Chesapeake Urology Research Associates
Hanover, Maryland, 21076
Baylor College of Medicine
Houston, Texas, 77030
Las Colinas OBGYN
Irving, Texas, 75062
MacArthur OB/GYN Management, LLC
Irving, Texas, 75062
Loma Linda University Medical Center
Loma Linda, California, 92354
Kyle P. McMorries, MD
Nacogdoches, Texas, 75965
Physicians Regional Healthcare
Naples, Florida, 34105
Christiana Hospital
Newark, Delaware, 19713
Norwalk Hospital
Norwalk, Connecticut, 06850
Permian Research Foundation
Odessa, Texas, 79761
Scripps Clinic Carmel Valley
San Diego, California, 92130
Lyndhurst Clinical Research
Winston-Salem, North Carolina, 27103
Genesis Healthcare System
Zanesville, Ohio, 43701
About this study
Official title: A Prospective, Non-Randomized, Parallel Cohort, Multi-center Study of the Solyx™ Single Incision Sling System vs. the Obtryx™ II Sling System for the Treatment of Women With Stress Urinary Incontinence
The purpose of this research study is to compare the treatment device (Solyx) to a different mesh sling or control device (Obtryx II) for the treatment of symptoms for Stress Urinary Incontinence (SUI). Safety information and patient outcomes will be collected for three (3) years and evaluated.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Solyx Single Incision Sling System, Obtryx II Sling System
- 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 Single Incision Sling SystemDevice
Solyx Single Incision Sling System
Obtryx II Sling SystemDevice
Standard outside-in transobturator sling
| Study group | Role | What they receive |
|---|---|---|
| Solyx Single Incision Sling System | Active comparator | Solyx Single Incision Sling System Receives: Device: Solyx Single Incision Sling System |
| Obtryx II Sling System | Active comparator | Obtryx II Sling System Receives: Device: Obtryx II Sling System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Meeting Definition of Treatment Success at 36 Months, by a Composite of Objective and Subjective Measures
An assessment of improvement in stress urinary incontinence at 36 months, by a composite of objective (negative cough stress test with protocol required bladder fill procedure) and subjective measures (subject self reported improvement in their condition, through the Patient Global Impression of Improvement (PGI-I)). The PGI-I scale rates the patient's improvement or worsening of SUI symptoms relative to baseline. The scale is as follows: 1 - Very much better; 2 - Much better; 3 - A little better; 4 - No change' 5 - A little worse; 6 - Much worse; 7 - Very much worse, with the unit of measure being scores on a scale (lower scores indicate a more positive impression of change). Subjects met the definition of treatment success at 36 months if they had an answer of "No" to the item "Direct observation of urine loss with cough provocation" and an Improvement per the PGI-I (a response of "A little better", "Much better", or "Very much better").
Measured: Data presented is for 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2013 (estimated)
- Study startJun 2013
- Primary completion17 Jan 2018
- Study completion17 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 281 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Amanda White, MD, Principal investigator, University of TexasJoseph Schaffer, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01784588
- Sponsor's protocol ID
- U9915-Solyx
- Acronym
- Solyx
- Status last verified
- Jan 2021
- First submitted
- 4 Feb 2013
- Last updated
- 10 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
White AB, Anger JT, Eilber K, Kahn BS, Gonzalez RR, Rosamilia A. Female Sexual Function following Sling Surgery: A Prospective Parallel Cohort, Multi-Center Study of the Solyx Single Incision Sling System versus the Obtryx II Sling System. J Urol. 2021 Sep;206(3):696-705. doi: 10.1097/JU.0000000000001830. Epub 2021 May 6.
PubMed 33955778
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Non-Randomized, Parallel Cohort, Multi-center Study of the Solyx™ Single Incision Sling System vs. the Obtryx™ II Sling System for the Treatment of Women With Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT01784588
- Acronym / sponsor ID
- Solyx / U9915-Solyx
- Conditions
- Stress Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 281 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- 17 Jan 2018 (actual)
- Study completion
- 17 Jan 2018 (actual)
- First posted
- 6 Feb 2013 (estimated)
- Results
- Posted 6 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to compare the treatment device (Solyx) to a different mesh sling or control device (Obtryx II) for the treatment of symptoms for Stress Urinary Incontinence (SUI). Safety information and patient outcomes will be collected for three (3) years and evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Solyx Single Incision Sling System | Active comparator | Device: Solyx Single Incision Sling SystemSolyx Single Incision Sling System |
| Obtryx II Sling System | Active comparator | Device: Obtryx II Sling SystemObtryx II Sling System |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female ≥ 18 years of age
- Willing and able to comply with the study procedures and provide written informed consent to participate in the study (subject or legal representative)
- Diagnosed with predominant SUI confirmed by positive cough stress test during the protocol required bladder fill procedure (see manual of operations)
- Confirmed SUI is greater than urge incontinence with the Medical Epidemiologic Social Aspect (MESA) questionnaire
- Cystometric capacity ≥ 300 cc
Key exclusion criteria (17 listed)
- Subjects who are pregnant, lactating, or planning future pregnancies
- Subjects with a chief complaint of overactive bladder
- Subjects with a pattern of recurrent urinary tract infections, defined as ≥ 2 culture-proven urinary tract infections during a 6-month period prior to surgery or ≥ 3 in a 12-month period
- Subjects with previous surgical procedures for SUI including bulking, urethral sling, bone anchor, Burch procedure, pubo-vaginal sling, and Marshall-Marchetti-Krantz (MMK) procedure. Excluding Kelly plication, Botox, anterior repair, or Inter-Stim
- Subjects with prior pelvic organ prolapse surgery who experienced mesh complications
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 Single Incision Sling SystemSolyx Single Incision Sling System | Device | Solyx Single Incision Sling System |
| Obtryx II Sling SystemStandard outside-in transobturator sling | Device | Obtryx II Sling System |
Primary outcome
Number of Subjects Meeting Definition of Treatment Success at 36 Months, by a Composite of Objective and Subjective Measures
Time frame: Data presented is for 36 months
An assessment of improvement in stress urinary incontinence at 36 months, by a composite of objective (negative cough stress test with protocol required bladder fill procedure) and subjective measures (subject self reported improvement in their condition, through the Patient Global Impression of Improvement (PGI-I)). The PGI-I scale rates the patient's improvement or worsening of SUI symptoms relative to baseline. The scale is as follows: 1 - Very much better; 2 - Much better; 3 - A little better; 4 - No change' 5 - A little worse; 6 - Much worse; 7 - Very much worse, with the unit of measure being scores on a scale (lower scores indicate a more positive impression of change). Subjects met the definition of treatment success at 36 months if they had an answer of "No" to the item "Direct observation of urine loss with cough provocation" and an Improvement per the PGI-I (a response of "A little better", "Much better", or "Very much better").
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33955778White AB, Anger JT, Eilber K, Kahn BS, Gonzalez RR, Rosamilia A. Female Sexual Function following Sling Surgery: A Prospective Parallel Cohort, Multi-Center Study of the Solyx Single Incision Sling System versus the Obtryx II Sling System. J Urol. 2021 Sep;206(3):696-705. doi: 10.1097/JU.0000000000001830. Epub 2021 May 6.
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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.
Amanda White, MD principal investigator
University of Texas
Joseph Schaffer, MD principal investigator
University of Texas Southwestern Medical Center
23 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Solyx Single Incision Sling System and Obtryx II Sling System in people with Stress Urinary Incontinence, run by Boston Scientific Corporation at 23 sites in 2 countries.
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 7 inclusion and 17 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: finished, as of the sponsor's last update on 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, Australia. 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?
Yes. Results are posted in the registry (first posted 6 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects Meeting Definition of Treatment Success at 36 Months, by a Composite of Objective and Subjective Measures (time frame: Data presented is for 36 months). 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 NCT01784588, which also lists 1 linked publication.
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 10 Feb 2021.