Stress Urinary Incontinence
Conditions
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.
Interventions
DEVICESolyx Single Incision Sling System
Solyx Single Incision Sling System
DEVICEObtryx II Sling System
Standard outside-in transobturator sling
Sponsors
Boston Scientific Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Meeting Definition of Treatment Success at 36 Months, by a Composite of Objective and Subjective Measures | 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). |
Countries
Australia, United States
Participant flow
Recruitment details
Subject enrollment began on August 1, 2013 and was completed on December 23, 2014.
Participants by arm
| Arm | Count |
|---|---|
| Solyx Single Incision Sling System Solyx Single Incision Sling System
Solyx Single Incision Sling System: Solyx Single Incision Sling System | 141 |
| Obtryx II Sling System Obtryx II Sling System
Obtryx II Sling System: Standard outside-in transobturator sling | 140 |
| Total | 281 |
Baseline characteristics
| Characteristic | Obtryx II Sling System | Total | Solyx Single Incision Sling System |
|---|---|---|---|
| Age, Continuous | 48.9 Years STANDARD_DEVIATION 11.7 | 49.0 Years STANDARD_DEVIATION 11.6 | 49.1 Years STANDARD_DEVIATION 11.6 |
| Body Mass Index | 29.7 lb/in^2 STANDARD_DEVIATION 6.3 | 29.6 lb/in^2 STANDARD_DEVIATION 6.8 | 29.6 lb/in^2 STANDARD_DEVIATION 7.3 |
| Current Hormone Replacement Therapy (HRT) Combination Replacement Therapy | 3 Participants | 10 Participants | 7 Participants |
| Current Hormone Replacement Therapy (HRT) None | 120 Participants | 230 Participants | 110 Participants |
| Current Hormone Replacement Therapy (HRT) Oral Estrogen | 5 Participants | 16 Participants | 11 Participants |
| Current Hormone Replacement Therapy (HRT) Other | 4 Participants | 5 Participants | 1 Participants |
| Current Hormone Replacement Therapy (HRT) Transdermal Estrogen | 0 Participants | 1 Participants | 1 Participants |
| Current Hormone Replacement Therapy (HRT) Vaginal Estrogen | 8 Participants | 19 Participants | 11 Participants |
| Diabetes Diet Controlled | 4 Participants | 5 Participants | 1 Participants |
| Diabetes Insulin Controlled | 2 Participants | 4 Participants | 2 Participants |
| Diabetes None | 128 Participants | 264 Participants | 136 Participants |
| Diabetes Oral Agent Controlled | 6 Participants | 8 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 35 Participants | 49 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 105 Participants | 232 Participants | 127 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Hysterectomy Laparoscopic Assisted Vaginal | 3 Participants | 10 Participants | 7 Participants |
| Hysterectomy Laparoscopy | 3 Participants | 12 Participants | 9 Participants |
| Hysterectomy Laparotomy | 7 Participants | 16 Participants | 9 Participants |
| Hysterectomy None | 106 Participants | 207 Participants | 101 Participants |
| Hysterectomy Robotic | 2 Participants | 4 Participants | 2 Participants |
| Hysterectomy Vaginal | 19 Participants | 32 Participants | 13 Participants |
| Menopausal Status Perimenopausal | 12 Participants | 28 Participants | 16 Participants |
| Menopausal Status Postmenopausal | 48 Participants | 101 Participants | 53 Participants |
| Menopausal Status Premenopausal | 80 Participants | 152 Participants | 72 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 6 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 19 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 9 Participants | 4 Participants |
| Race (NIH/OMB) White | 123 Participants | 247 Participants | 124 Participants |
| Region of Enrollment Australia | 0 participants | 18 participants | 18 participants |
| Region of Enrollment United States | 140 participants | 263 participants | 123 participants |
| Sex: Female, Male Female | 140 Participants | 281 Participants | 141 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Smoking Status Current | 22 Participants | 35 Participants | 13 Participants |
| Smoking Status Never | 88 Participants | 189 Participants | 101 Participants |
| Smoking Status Previous | 30 Participants | 57 Participants | 27 Participants |
| Smoking Status Unknown | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 141 | 1 / 140 |
| other Total, other adverse events | 14 / 141 | 21 / 140 |
| serious Total, serious adverse events | 1 / 141 | 1 / 140 |
Outcome results
Primary
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).
Time frame: Data presented is for 36 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Solyx Single Incision Sling System | Number of Subjects Meeting Definition of Treatment Success at 36 Months, by a Composite of Objective and Subjective Measures | 94 Participants |
| Obtryx II Sling System | Number of Subjects Meeting Definition of Treatment Success at 36 Months, by a Composite of Objective and Subjective Measures | 96 Participants |
Comparison: Available Cases Only - Intent-to-Treat90% CI: [-8.2, 7.4]
Comparison: Available Cases Only - Intent-to-Treat90% CI: [-5.4, 8.4]