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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01784588




Registration number
NCT01784588
Ethics application status
Date submitted
4/02/2013
Date registered
6/02/2013
Date last updated
9/08/2019

Titles & IDs
Public title
Post Market Study Of Single Incision Sling Versus Transobturator Sling for Stress Urinary Incontinence
Scientific 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
Secondary ID [1] 0 0
U9915-Solyx
Universal Trial Number (UTN)
Trial acronym
Solyx
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stress Urinary Incontinence 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Solyx Single Incision Sling System
Treatment: Devices - Obtryx II Sling System

Active Comparator: Solyx Single Incision Sling System - Solyx Single Incision Sling System

Active Comparator: Obtryx II Sling System - Obtryx II Sling System


Treatment: Devices: Solyx Single Incision Sling System
Solyx Single Incision Sling System

Treatment: Devices: Obtryx II Sling System
Standard outside-in transobturator sling

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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").
Timepoint [1] 0 0
Data presented is for 36 months

Eligibility
Key inclusion criteria
1. Female = 18 years of age

2. Willing and able to comply with the study procedures and provide written informed
consent to participate in the study (subject or legal representative)

3. Diagnosed with predominant SUI confirmed by positive cough stress test during the
protocol required bladder fill procedure (see manual of operations)

4. Confirmed SUI is greater than urge incontinence with the Medical Epidemiologic Social
Aspect (MESA) questionnaire

5. Cystometric capacity = 300 cc

6. Post-void residual (PVR) of = 150 cc

7. Medically approved for general, regional or monitored anesthesia
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subjects who are pregnant, lactating, or planning future pregnancies

2. Subjects with a chief complaint of overactive bladder

3. 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

4. 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

5. Subjects with prior pelvic organ prolapse surgery who experienced mesh complications

6. Subjects with previous radiation therapy to the pelvis

7. Subjects with known or suspected hypersensitivity to polypropylene mesh

8. Subjects with any of the following confounding conditions:

1. Neurogenic bladder

2. Urethral stricture and bladder neck contracture

3. Bladder stones or tumors

4. Urinary tract fistula or diverticula

5. Pathology which would compromise implant placement including subjects currently
taking anticoagulation therapy

6. Pathology that would limit blood supply or infections that would compromise
healing including chemotherapy, systemic steroids and systemic immunosuppressants

9. Subjects with diabetes and an A1c = 7%

10. Non-English speaking subjects

11. 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Cabrini Medical Centre - Malvern
Recruitment postcode(s) [1] 0 0
- Malvern
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Delaware
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
North Dakota
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Tennessee
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
United States of America
State/province [12] 0 0
Washington

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Boston Scientific Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/show/NCT01784588
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Amanda White, MD
Address 0 0
University of Texas
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications