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An international, multi-center, single arm, prospective clinical study designed to assess the safety and efficacy of the Coloplast Altis single incision sling system for females with stress urinary incontinence (SUI).
An international, multi-center, single arm, prospective clinical study designed to assess the safety and efficacy of the Coloplast Altis single incision sling system for females with stress urinary incontinence (SUI). Primary Objective: Improvement in continence measured by 24 hour pad weight test with at least a 50% reduction in weight from baseline at 6 months. Secondary Objectives: Cough stress test results at 6 months; Subject QoL as measured by validated questionnaires: PGI-I, improvements in UDI-6 and IIQ-7 scores from baseline at 6 months, 3 day voiding diary improvement from baseline at 6 months; Device and procedure related adverse events. Brief Entrance Criteria: Adult female with confirmed SUI through cough stress test or urodynamics; Failed two non-invasive incontinence therapies; No prior surgical SUI treatment; No prolapse POP-Q Stage 2 or higher; No concurrent pelvic floor procedure; No urge predominant incontinence; No incontinence due to neurological disorder/disease; No PVR > 100cc; and, No contraindication to the surgical procedure. Study visits will take place at baseline, implant/hospitalization, 3 months, 6 months, 1 year, and 2 years post operatively. This study will enroll up to 113 subjects at up to 17 investigative sites in the US and Internationally.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Altis® SIS | Other | Subjects enrolled with Altis® SIS |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Altis® Single Incision Sling System (SIS) | Device | The Altis® SIS is a permanently implantable synthetic sling for females placed at the mid-urethra to provide a scaffold for tissue in-growth and support for stress urinary incontinence. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With at Least 50% Reduction in 24-hour Pad Weight From Baseline to 6 Months | Primary endpoint defined as at least a 50% reduction in 24-hour pad weight from baseline to 6 months (including dry as defined as a pad weight of less than 1.3 grams during the 6-month test), in which the percent of subjects with at least 50% reduction in 24-hour pad weight is compared to a performance goal of 50%. | 6 months (compared to baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Negative Cough Stress Test at 6 Months | Endpoint defined as a negative result at 6 months, as measured by the Cough Stress Test (CST), in which the percent of subjects with a negative CST is compared to a performance goal of 66%. The cough stress test was completed with the subject in the lithotomy and standing positions, filling bladder to maximum capacity with normal saline. The subject was then asked to cough 10 times and any leakage from the urethra was considered a positive test. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ervin Kocjancic, MD | University of Chicago, Chicago, IL, United States | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tri Valley Urology | Murrieta | California | 92562 | United States | ||
| Urology Specialists, LLC |
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Women with documented stress urinary incontinence (SUI) who met enrollment criteria
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| ID | Title | Description |
|---|---|---|
| FG000 | Altis® SIS | Participants implanted with Altis® Single Incision Sling |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| 3-month Follow-up Visit |
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| 6 months |
| Percentage of Participants With at Least 50% Improvement in Incontinence Via 3-Day Voiding Diary From Baseline to 6 Months | Endpoint defined as at least a 50% improvement from baseline to 6-months, as measured by 3-Day Voiding Diary, in which the percent of subjects with at least a 50% improvement from baseline to 6 months is compared to a performance goal of 50%. Subjects completed a 3-Day Voiding Diary of controlled urinations and the number and amount of leaks experienced. | 6 months (compared to baseline) |
| Percentage of Participants With at Least 50% Improvement in UDI-6 Score From Baseline to 6 Months | Endpoint defined as at least a 50% improvement from baseline to 6 months, as measured by validated Urinary Distress Inventory Short Form (UDI-6), in which the percent of subjects with at least a 50% improvement from baseline to 6 months is compared to a performance goal of 50%. | 6 months (compared to baseline) |
| Percentage of Participants With at Least 50% Improvement in IIQ-7 From Baseline to 6 Months | Endpoint defined as at least a 50% improvement from baseline to 6 months, as measured by validated Incontinence Impact Questionnaire Short Form (IIQ-7), in which the percent of subjects with at least a 50% improvement from baseline to 6 months is compared to a performance goal of 50%. | 6 months (compared to baseline) |
| Percentage of Patients Responding "Very Much Better" or "Much Better" on PGI-I at 6 Months | Success defined as a response of "Very Much Better" or "Much Better" at 6 months, as measured by validated Patient Global Impression of Improvement (PGI-I). | 6 months |
| Percentage of Participants With at Least 50% Reduction in 24-hour Pad Weight From Baseline to 12 Months | Success is defined as at least a 50% reduction in 24-hour pad weight from baseline to 12 months using the 24 hour pad weight test. | 12 months (compared to baseline) |
| Percentage of Participants With Negative Cough Stress Test at 12 Months | Success defined as a negative result at 12 months, as measured by the Cough Stress Test (CST). The cough stress test was completed with the subject in the lithotomy and standing positions, filling bladder to maximum capacity with normal saline. The subject was then asked to cough 10 times and any leakage from the urethra was considered a positive test. | 12 months (compared to baseline) |
| Percentage of Participants With at Least 50% Improvement in UDI-6 Score From Baseline to 12 Months | Success defined as at least a 50% improvement from baseline to 12 months, as measured by validated Urinary Distress Inventory Short Form (UDI-6) | 12 months (compared to baseline) |
| Percentage of Participants With at Least 50% Improvement in IIQ-7 From Baseline to 12 Months | Success defined as at least a 50% improvement from baseline to 12 months, as measured by validated Incontinence Impact Questionnaire Short Form (IIQ-7) | 12 months (compared to baseline) |
| Percentage of Patients Responding "Very Much Better" or "Much Better" on PGI-I at 12 Months | Success defined as a response of "Very Much Better" or "Much Better" at 12 months, as measured by validated Patient Global Impression of Improvement (PGI-I). | 12 months |
| Hialeah |
| Florida |
| 33016 |
| United States |
| Atlanta Medial Research Institute | Alpharetta | Georgia | 30005 | United States |
| Rosemark Womencare Specialist | Idaho Falls | Idaho | 83404 | United States |
| University of Illinois at Chicago - Department of Urology | Chicago | Illinois | 60612 | United States |
| Illinois Urogynecology, LTD | Oak Lawn | Illinois | 60453 | United States |
| Female Pelvic Medicine & Urogynecology Institute of Michigan | Grand Rapids | Michigan | 49503 | United States |
| Bellevue ObGyn | Bellevue | Nebraska | 68123 | United States |
| Delaware Valley Urology | Voorhees Township | New Jersey | 08043 | United States |
| Carolina Urology Partners | Gastonia | North Carolina | 28054 | United States |
| The University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| Greenville Hospital System | Greenville | South Carolina | 29605 | United States |
| Carolina Urologic Research Center | Myrtle Beach | South Carolina | 29572 | United States |
| The Group for Women | Norfolk | Virginia | 23502 | United States |
| Eastern Virginia Medical School | Norfolk | Virginia | 23507 | United States |
| Johnston Willis Medical Center | Richmond | Virginia | 23235 | United States |
| CHUS Hopital Fleurimont | Sherbrooke | Quebec | J1H 5N4 | Canada |
| COMPLETED |
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| NOT COMPLETED |
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| 6-month Follow-up Visit |
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| 12-month Follow-up Visit |
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| ID | Title | Description |
|---|---|---|
| BG000 | Altis® SIS | Participants implanted with Altis® Single Incision Sling |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With at Least 50% Reduction in 24-hour Pad Weight From Baseline to 6 Months | Primary endpoint defined as at least a 50% reduction in 24-hour pad weight from baseline to 6 months (including dry as defined as a pad weight of less than 1.3 grams during the 6-month test), in which the percent of subjects with at least 50% reduction in 24-hour pad weight is compared to a performance goal of 50%. | Analysis was per protocol. 109 subjects were eligible for 6-month follow-up. 6 subjects missed either the visit or the pad weight test. | Posted | Number | percentage of participants | 6 months (compared to baseline) |
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| Secondary | Percentage of Participants With Negative Cough Stress Test at 6 Months | Endpoint defined as a negative result at 6 months, as measured by the Cough Stress Test (CST), in which the percent of subjects with a negative CST is compared to a performance goal of 66%. The cough stress test was completed with the subject in the lithotomy and standing positions, filling bladder to maximum capacity with normal saline. The subject was then asked to cough 10 times and any leakage from the urethra was considered a positive test. | 109 subjects were eligible for 6-month follow-up. 6 subjects missed either the visit or the cough stress test. | Posted | Number | percentage of participants | 6 months |
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| Secondary | Percentage of Participants With at Least 50% Improvement in Incontinence Via 3-Day Voiding Diary From Baseline to 6 Months | Endpoint defined as at least a 50% improvement from baseline to 6-months, as measured by 3-Day Voiding Diary, in which the percent of subjects with at least a 50% improvement from baseline to 6 months is compared to a performance goal of 50%. Subjects completed a 3-Day Voiding Diary of controlled urinations and the number and amount of leaks experienced. | 109 subjects were eligible for 6-month follow-up. 17 subjects either missed the visit or did not complete the 3-Day Voiding Diary. | Posted | Number | percentage of participants | 6 months (compared to baseline) |
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| Secondary | Percentage of Participants With at Least 50% Improvement in UDI-6 Score From Baseline to 6 Months | Endpoint defined as at least a 50% improvement from baseline to 6 months, as measured by validated Urinary Distress Inventory Short Form (UDI-6), in which the percent of subjects with at least a 50% improvement from baseline to 6 months is compared to a performance goal of 50%. | 109 subjects were eligible for 6-month follow-up. 4 subjects either missed the visit or did not complete the Urinary Distress Inventory. | Posted | Number | percentage of participants | 6 months (compared to baseline) |
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| Secondary | Percentage of Participants With at Least 50% Improvement in IIQ-7 From Baseline to 6 Months | Endpoint defined as at least a 50% improvement from baseline to 6 months, as measured by validated Incontinence Impact Questionnaire Short Form (IIQ-7), in which the percent of subjects with at least a 50% improvement from baseline to 6 months is compared to a performance goal of 50%. | 109 subjects were eligible for 6-month follow-up. 5 subjects either missed the visit or did not complete the Incontinence Impact Questionnaire. | Posted | Number | percentage of participants | 6 months (compared to baseline) |
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| Secondary | Percentage of Patients Responding "Very Much Better" or "Much Better" on PGI-I at 6 Months | Success defined as a response of "Very Much Better" or "Much Better" at 6 months, as measured by validated Patient Global Impression of Improvement (PGI-I). | 109 subjects were eligible for 6-month follow-up. 4 subjects either missed the visit or did not complete the PGI-I. | Posted | Number | percentage of participants | 6 months |
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| Secondary | Percentage of Participants With at Least 50% Reduction in 24-hour Pad Weight From Baseline to 12 Months | Success is defined as at least a 50% reduction in 24-hour pad weight from baseline to 12 months using the 24 hour pad weight test. | 105 subjects were eligible for 12-month follow-up. 4 subjects missed either the visit or the pad weight test. | Posted | Number | percentage of participants | 12 months (compared to baseline) |
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| Secondary | Percentage of Participants With Negative Cough Stress Test at 12 Months | Success defined as a negative result at 12 months, as measured by the Cough Stress Test (CST). The cough stress test was completed with the subject in the lithotomy and standing positions, filling bladder to maximum capacity with normal saline. The subject was then asked to cough 10 times and any leakage from the urethra was considered a positive test. | 105 subjects were eligible for 12-month follow-up. 4 subjects missed either the visit or the cough stress test. | Posted | Number | percentage of participants | 12 months (compared to baseline) |
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| Secondary | Percentage of Participants With at Least 50% Improvement in UDI-6 Score From Baseline to 12 Months | Success defined as at least a 50% improvement from baseline to 12 months, as measured by validated Urinary Distress Inventory Short Form (UDI-6) | 105 subjects were eligible for 12-month follow-up. 2 subjects either missed the visit or did not complete the UDI-6. | Posted | Number | percentage of participants | 12 months (compared to baseline) |
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| Secondary | Percentage of Participants With at Least 50% Improvement in IIQ-7 From Baseline to 12 Months | Success defined as at least a 50% improvement from baseline to 12 months, as measured by validated Incontinence Impact Questionnaire Short Form (IIQ-7) | 105 subjects were eligible for 12-month follow-up. 2 subjects either missed the visit or did not complete the IIQ-7. | Posted | Number | percentage of participants | 12 months (compared to baseline) |
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| Secondary | Percentage of Patients Responding "Very Much Better" or "Much Better" on PGI-I at 12 Months | Success defined as a response of "Very Much Better" or "Much Better" at 12 months, as measured by validated Patient Global Impression of Improvement (PGI-I). | 105 subjects were eligible for 12-month follow-up. 2 subjects either missed the visit or did not complete the PGI-I. | Posted | Number | percentage of participants | 12 months |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Altis® SIS | Participants implanted with Altis® Single Incision Sling | 3 | 113 | 9 | 113 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematoma | Surgical and medical procedures | Systematic Assessment | Pelvic hematoma, resolved spontaneously in hospital |
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| Mesh extrusion | Surgical and medical procedures | Systematic Assessment | Subject underwent surgical revision due to symptoms |
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| Mesh extrusion | Surgical and medical procedures | Systematic Assessment | Classified as serious adverse event (SAE) due to subject withdrawal from study prior to further follow-up data collection |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-pelvic pain | Surgical and medical procedures | Systematic Assessment | Procedure-related non-pelvic pain |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Manager | Coloplast Corp | 612-302-4990 | usdibe@coloplast.com |
| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| D014549 | Urinary Incontinence |
| D010335 | Pathologic Processes |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| ID | Term |
|---|---|
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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