Stress Urinary Incontinence
Conditions
Keywords
stress urinary incontinence, Altis 522, urinary incontinence
Brief summary
The aim of this postmarket study is to compare the safety and effectiveness of the Altis Single Incision Sling (SIS) to an FDA cleared transobturator and/or retropubic sling through 36 months.
Detailed description
This study is a prospective, post-market, multi-center, cohort assessment comparing Altis SIS (n=178) and transobturator and/or retropubic slings (n=178) in the treatment of stress urinary incontinence at up to 40 U.S. and international sites. Subjects will be followed for a total of 36 months with scheduled visits at 6, 12, 18, 24 and 36 months. The study population will consist of adult female subjects with stress urinary incontinence who are clinically indicated for surgical intervention with a mesh sling.
Interventions
Altis is a minimally invasive, adjustable incontinence sling that is placed through a single incision in the vaginal wall and anchored inside the body. The sling has an integrated tensioning system eliminating the need for additional skin exits.
DEVICETransobturator or Retropubic Sling
Both transobturator and retropubic slings are a hammock-like mesh placed underneath the urethra to provide support. A single incision is made in the vaginal wall and two incisions in the abdomen. Tensioning of the sling is achieved by pulling the sling through the abdominal incisions.
Sponsors
Coloplast A/S
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The subject is female and at least 18 years of age. * The subject is able and willing to complete all procedures and follow-up visits indicated in this protocol. * The subject has confirmed stress urinary incontinence (SUI) through cough stress test or urodynamics. * The subject has failed two non-invasive incontinence therapies (such as Kegel exercise, behavior modification, pad use, biofeedback, etc.) for \> 6 months.
Exclusion criteria
* The subject has an active urogenital infection or active skin infection in region of surgery. * The subject has confirmed Pelvic Organ Prolapse (POP) of Stage 2 or higher as determined by POP-Q prolapse grading. * The subject is having a concomitant pelvic floor procedure. * The subject has incontinence due to neurogenic causes (e.g. multiple sclerosis, spinal cord/brain injury, cerebrovascular accident, detrusor-external sphincter dyssynergia, Parkinson's disease, or similar conditions). * The subject had a prior surgical stress urinary incontinence (SUI) treatment. * The subject has undergone radiation or brachy therapy to treat pelvic cancer. * The subject has urge predominant incontinence by MESA assessment. * The subject has an atonic bladder or post void residual (PVR) above 100 cc on ≥ 2 occasions. * The subject is pregnant and/or is planning to get pregnant in the future. * The subject has a contraindication to the surgical procedure or the product Instructions for Use (IFU). * The subject is enrolled in a concurrent clinical trial of any treatment (drug or device) that could affect continence function, without the sponsors approval.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Effectiveness Endpoint | 6 months | Observed effectiveness, defined as a reduction from baseline in 24 hour pad weight of at least 50% at 6 months. |
| Primary Safety Endpoint | 36 months | Observed device and/or procedure-related serious adverse events through 36 months. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Altis Arm Subjects will have an Altis sling placed to treat stress urinary incontinence. | 213 |
| Comparator Arm Subjects will have a transobturator or retropubic sling placed to treat stress urinary incontinence. | 203 |
| Total | 416 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
| Overall Study | Lost to Follow-up | 24 | 20 |
| Overall Study | Physician Decision | 17 | 15 |
| Overall Study | Site closed due to PI leaving | 0 | 30 |
| Overall Study | Sponsor withdrawal | 0 | 7 |
| Overall Study | Withdrawal by Subject | 32 | 29 |
Baseline characteristics
| Characteristic | Altis Arm | Total | Comparator Arm |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 58 Participants | 105 Participants | 47 Participants |
| Age, Categorical Between 18 and 65 years | 153 Participants | 308 Participants | 155 Participants |
| Age, Continuous | 56.4 years STANDARD_DEVIATION 11.8 | 55.1 years STANDARD_DEVIATION 12 | 53.6 years STANDARD_DEVIATION 12 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 55 Participants | 80 Participants | 25 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 156 Participants | 333 Participants | 177 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 1 Participants |
| Pad Weight (g) | 88.0 grams STANDARD_DEVIATION 155.8 | 92.3 grams STANDARD_DEVIATION 155.1 | 96.8 grams STANDARD_DEVIATION 154.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 15 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 9 Participants | 5 Participants |
| Race (NIH/OMB) White | 205 Participants | 386 Participants | 181 Participants |
| Region of Enrollment Canada | 44 participants | 44 participants | 0 participants |
| Region of Enrollment United States | 169 participants | 372 participants | 203 participants |
| Sex: Female, Male Female | 213 Participants | 416 Participants | 203 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 184 | 1 / 171 |
| other Total, other adverse events | 74 / 184 | 66 / 171 |
| serious Total, serious adverse events | 24 / 184 | 29 / 171 |
Outcome results
Primary
Primary Effectiveness Endpoint
Observed effectiveness, defined as a reduction from baseline in 24 hour pad weight of at least 50% at 6 months.
Time frame: 6 months
Population: All enrolled subjects (Intent-to-Treat (ITT) analysis population) who have undergone a sling implant attempt for stress urinary incontinence using either Altis SIS or an FDA cleared transobturator or retropubic sling (modified Intent-to-Treat (mITT) analysis population). The mITT analysis population is a subset of the ITT population. The mITT analysis population is the primary analysis population for the assessment of all safety and effectiveness endpoints.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Altis Arm | Primary Effectiveness Endpoint | 130 Participants |
| Comparator Arm | Primary Effectiveness Endpoint | 119 Participants |
p-value: 0.01395% CI: [-0.139, 0.031]Normal approximation test (Z-test)
Primary
Primary Safety Endpoint
Observed device and/or procedure-related serious adverse events through 36 months.
Time frame: 36 months
Population: All enrolled subjects (Intent-to-Treat (ITT) analysis population) who have undergone a sling implant attempt for stress urinary incontinence using either Altis SIS or an FDA cleared transobturator or retropubic sling (modified Intent-to-Treat (mITT) analysis population). The mITT analysis population is a subset of the ITT population. The mITT analysis population is the primary analysis population for the assessment of all safety and effectiveness endpoints.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Altis Arm | Primary Safety Endpoint | 2 Participants |
| Comparator Arm | Primary Safety Endpoint | 4 Participants |
p-value: <0.000195% CI: [-0.023, 0.048]Normal approximation test (Z-test)