|
|
| General |
| Study Status |
Completed |
| 522 Number / Requirement Number |
PS130039 / PSS001 |
| Date Original Plan Accepted |
12/06/2013
|
| Date Current Plan Accepted |
02/11/2019
|
| Study Name |
AE and effectiveness rates
|
| Device Name |
Altis single incision sling system
|
| Root Document Number |
K121562
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Concurrent Control
|
| Analysis Type |
Analytical
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
This study is a prospective, multi-center, cohort assessment comparing Altis SIS and transobturator and/or retropubic slings in the treatment of stress urinary incontinence, at up to 40 U.S. and International sites.
|
| Study Population |
The study population will consist of adult female subjects with stress urinary incontinence who are clinically indicated for surgical intervention with a mesh sling, who have received Altis SIS as part of the previous IDE study (CP006SU [G100229]) or who are currently clinically indicated for surgical intervention with a mesh sling. All study candidates who provide written informed consent and meet all of the inclusion criteria and none of the exclusion criteria will be included in the study.
|
| Sample Size |
Sample size was calculated to assess non-inferiority of the primary efficacy endpoint and primary safety endpoint at 80% power with a type-1 error rate of 0.05 for each primary endpoint analysis. The final sample size was determined to be the maximum of these sample size calculations for the primary efficacy and safety endpoints. This requires 328 total subjects from up to 40 sites, comparing Altis SIS (n=178) and transobturator and/or retropubic slings (n=178) in the treatment of stress urinary incontinence
|
| Key Study Endpoints |
Primary Safety Endpoints Observed device and/or procedure-related serious adverse events through 36-months. Primary Effectiveness Endpoint Observed effectiveness, defined as a reduction from baseline in 24 hour pad weight of at least 50 % at 6 months. Secondary Safety Endpoints Observed rates of device and/or procedure-related adverse events defined as organ perforation, bleeding, mesh exposure in the vagina, mesh erosion into the bladder, pelvic pain, infection, de novo dyspareunia, urinary retention, recurrent incontinence, other urinary problems and neuromuscular problems at 6 months, 12 months, 18 months, 24 months, and 36 months post index procedure. Observed adverse events within 6 months, 12 months, 18 months, 24 months, and 36 months of the index procedure. Observed revision/re-surgery at the index level at 6 months, 12 months, 18 months, 24 months, and 36 months. Secondary Effectiveness Endpoint Observed effectiveness, defined as a reduction from baseline in 24 hour pad weight of at least 50 % at 12 months, 18 months, 24 months, and 36 months. Quality of Life at 6 months, 12 months, 18 months, 24 months, and 36 months as measured through: Patient Global Impression of Improvement (PGI-1) Urogenital Distress Inventory (UDI-6) Incontinence Impact Questionnaire-Short Form (IIQ-7)
|
| Follow-up Visits and Length of Follow-up |
The length of follow-up is 3 years. Data will be collected following the index procedure at 6 months, 12 months, 18 months, 24months, and 36 months.
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
416 subjects were enrolled. 184 subjects in the Altis arm and 171 subjects in the Comparator arm were implanted.
|
| Actual Number of Sites Enrolled |
32 Sites with IRB Approvals, 7 enrolled Altis patients, 10 enrolled Comparator patients, 6 enrolled both arms, 9 did not enroll patients.
|
| Patient Followup Rate |
Overall: 67.9% (241/355) completed 36 month follow-up; Altis: 76.1% (140/184) completed 36 month follow-up; Comparator: 59.1% (101/171) completed 36 month follow- up.
|
| Final Safety Findings |
Primary Safety Endpoint: Rate of device- and/or procedure-related serious adverse events (SAEs) compared to transobturator and/or retropubic slings through 36-months. 1.1% Altis (2/184) and 2.3% Comparator (4/171) subjects had a procedure and/or device-related SAE. For the Altis arm, SAEs were pelvic/urogenital pain two days after successful implant and urinary retention/obstruction after sling surgery, related to worsening of a large cystocele. For the comparator arm, SAEs were perforation of the bladder due to the surgery, delayed wound healing, recurrent mesh exposure along with midline incision separation and shortness of breath, chest pain, and left-sided jaw/neck pain.
Key Secondary Safety Endpoints
Adverse Events: There were 408 AEs in the comparator arm vs 521 AEs in the Altis arm over the 36 month follow up period, with 13.6% (25/184) in Altis and 12.3% (21/171) in the comparator being procedure and/or device related.
Explant Procedures: One explant procedure occurred in each arm over the 36 month follow up period. One Altis subject had an explant performed due to pelvic/urogenital pain. A comparator subject was explanted due to recurring wound separation and mesh exposure.
Revision/resurgery rate: Revision/resurgery in the Altis arm was conducted on 0.5% subjects (1/184) compared to 4.1% (7/171) Comparator subjects during the 36 month follow up period.
Non-Serious Adverse Events Not Related to the Procedure and/or the Device: Over the 36 month follow up period, the most common AE for both arms was urinary tract infection (21.2% (39/184) Altis and 22.8% (39/171) Comparator).
|
| Final Effectiveness Findings |
Primary effectiveness endpoint: Rate of reduction from baseline in 24-hour pad weight of at least 50% at 6 months. In the Altis arm, 70.7% (130/184) and in the comparator arm, 69.6% (119/171) subjects met the primary effectiveness endpoint.
Key secondary effectiveness endpoints
Pad Weight Success at 36 months (=50% reduction from baseline): 53.8% (99/184) of subjects in the Altis arm and 46.2% (79/171) in the comparator arm met this secondary effectiveness endpoint.
Dry Pad Weight Success (success defined as 4 grams or less) through 36 months: 42.3% (78/184) of subjects in the Altis arm and arm 36.2% (62/171) in the comparator met this secondary effectiveness endpoint.
Quality of Life: 70.6% (130/184) of Altis subjects reported a QoL success at 36 months (defined as ‘‘very much better’’ or ‘‘much better’’ through the Patient Global Impression of Improvement (PGI-I)); 53.2% (91/171) comparator subjects reported QoL success at 36 months.
|
| Study Strengths and Weaknesses |
The strengths of the Altis 522 Study include its large sample size, prospective, multicenter design and use of a wide variety of standardized and validated instruments to collect patient reported outcomes over a 36-month study duration.
The weaknesses of the Altis 522 study include differences in baseline characteristics between different subject groups, high attrition rate (at 36-months, the attrition rate for the Altis arm was 23.9%, whereas the attrition rate for the Comparator arm was 40.9%) and varying rates of subject enrollment across different study sites.
|
| Recommendations for Labeling Changes |
The sponsor submitted the labeling changes in the Special 510(k), K221874 which was cleared on 02/15/2023. The 522 study methods and key safety and effectiveness results collected from the 522 study were included on the labeling.
|
