Stress Urinary Incontinence
Conditions
Keywords
Female, Stress urinary incontinence, Mini sling, Single incision sling, Urinary incontinence, Mixed urinary incontinence, Additional relevant MESH terms:, Stress, Urinary Incontinence, Stress, Pathological Processes, Urination Disorders, Urological Disorders, Urological Manifestations, Signs and Symptoms
Brief summary
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).
Detailed description
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.
Interventions
DEVICEAltis® Single Incision Sling System (SIS)
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.
Sponsors
Coloplast A/S
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is female at least 18 years of age * Subject is able and willing to complete all procedures and follow-up visits indicated in this protocol * 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
* Subject has an active urogenital infection or active skin infection in region of surgery * Subject has confirmed Pelvic Organ Prolapse (POP) of Stage 2 or higher as determined by POP-Q prolapse grading * Subject is having a concomitant pelvic floor procedure * 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) * Subject had a prior surgical SUI treatment * Subject has undergone radiation or brachy therapy to treat pelvic cancer * Subject has urge predominant incontinence * Subject has an atonic bladder or a post void residual (PVR) consistently about 100cc * Subject is pregnant and/or is planning to get pregnant in the future * Subject has a contraindication to the surgical procedure or the Altis Instructions For Use (IFU) * Subject is enrolled in a concurrent clinical trial of any treatment (drug or device) that could affect continence function without the sponsor's approval
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With at Least 50% Reduction in 24-hour Pad Weight From Baseline to 6 Months | 6 months (compared to baseline) | 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%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With at Least 50% Improvement in Incontinence Via 3-Day Voiding Diary From Baseline to 6 Months | 6 months (compared to baseline) | 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. |
| Percentage of Participants With at Least 50% Improvement in UDI-6 Score From Baseline to 6 Months | 6 months (compared to baseline) | 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%. |
| Percentage of Participants With at Least 50% Improvement in IIQ-7 From Baseline to 6 Months | 6 months (compared to baseline) | 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%. |
| Percentage of Patients Responding Very Much Better or Much Better on PGI-I at 6 Months | 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). |
| Percentage of Participants With Negative Cough Stress Test at 6 Months | 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. |
| Percentage of Participants With Negative Cough Stress Test at 12 Months | 12 months (compared to baseline) | 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. |
| Percentage of Participants With at Least 50% Improvement in UDI-6 Score From Baseline to 12 Months | 12 months (compared to baseline) | Success defined as at least a 50% improvement from baseline to 12 months, as measured by validated Urinary Distress Inventory Short Form (UDI-6) |
| Percentage of Participants With at Least 50% Improvement in IIQ-7 From Baseline to 12 Months | 12 months (compared to baseline) | Success defined as at least a 50% improvement from baseline to 12 months, as measured by validated Incontinence Impact Questionnaire Short Form (IIQ-7) |
| Percentage of Patients Responding Very Much Better or Much Better on PGI-I at 12 Months | 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). |
| Percentage of Participants With at Least 50% Reduction in 24-hour Pad Weight From Baseline to 12 Months | 12 months (compared to baseline) | 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. |
Countries
Canada, United States
Participant flow
Recruitment details
Women with documented stress urinary incontinence (SUI) who met enrollment criteria
Participants by arm
| Arm | Count |
|---|---|
| Altis® SIS Participants implanted with Altis® Single Incision Sling | 113 |
| Total | 113 |
Baseline characteristics
| Characteristic | Altis® SIS |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 27 Participants |
| Age, Categorical Between 18 and 65 years | 86 Participants |
| Age, Continuous | 54.5 years STANDARD_DEVIATION 14 |
| Region of Enrollment Canada | 20 participants |
| Region of Enrollment United States | 93 participants |
| Sex: Female, Male Female | 113 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 9 / 113 |
| serious Total, serious adverse events | 3 / 113 |
Outcome results
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%.
Time frame: 6 months (compared to baseline)
Population: Analysis was per protocol. 109 subjects were eligible for 6-month follow-up. 6 subjects missed either the visit or the pad weight test.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Altis SIS® | Percentage of Participants With at Least 50% Reduction in 24-hour Pad Weight From Baseline to 6 Months | 85.4 percentage of participants |
Comparison: The final significance level is 0.04191 accounting for one interim analysis conducted at 80% of final information, thus a 95.81% Confidence Limit (CL) was used.p-value: <0.0001Fisher Exact
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)
Time frame: 12 months (compared to baseline)
Population: 105 subjects were eligible for 12-month follow-up. 2 subjects either missed the visit or did not complete the IIQ-7.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Altis SIS® | Percentage of Participants With at Least 50% Improvement in IIQ-7 From Baseline to 12 Months | 90.3 percentage of participants |
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%.
Time frame: 6 months (compared to baseline)
Population: 109 subjects were eligible for 6-month follow-up. 5 subjects either missed the visit or did not complete the Incontinence Impact Questionnaire.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Altis SIS® | Percentage of Participants With at Least 50% Improvement in IIQ-7 From Baseline to 6 Months | 93.3 percentage of participants |
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.
Time frame: 6 months (compared to baseline)
Population: 109 subjects were eligible for 6-month follow-up. 17 subjects either missed the visit or did not complete the 3-Day Voiding Diary.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Altis SIS® | Percentage of Participants With at Least 50% Improvement in Incontinence Via 3-Day Voiding Diary From Baseline to 6 Months | 88 percentage of participants |
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)
Time frame: 12 months (compared to baseline)
Population: 105 subjects were eligible for 12-month follow-up. 2 subjects either missed the visit or did not complete the UDI-6.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Altis SIS® | Percentage of Participants With at Least 50% Improvement in UDI-6 Score From Baseline to 12 Months | 89.3 percentage of participants |
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%.
Time frame: 6 months (compared to baseline)
Population: 109 subjects were eligible for 6-month follow-up. 4 subjects either missed the visit or did not complete the Urinary Distress Inventory.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Altis SIS® | Percentage of Participants With at Least 50% Improvement in UDI-6 Score From Baseline to 6 Months | 88.6 percentage of participants |
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.
Time frame: 12 months (compared to baseline)
Population: 105 subjects were eligible for 12-month follow-up. 4 subjects missed either the visit or the pad weight test.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Altis SIS® | Percentage of Participants With at Least 50% Reduction in 24-hour Pad Weight From Baseline to 12 Months | 90.1 percentage of participants |
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.
Time frame: 12 months (compared to baseline)
Population: 105 subjects were eligible for 12-month follow-up. 4 subjects missed either the visit or the cough stress test.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Altis SIS® | Percentage of Participants With Negative Cough Stress Test at 12 Months | 90.1 percentage of participants |
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.
Time frame: 6 months
Population: 109 subjects were eligible for 6-month follow-up. 6 subjects missed either the visit or the cough stress test.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Altis SIS® | Percentage of Participants With Negative Cough Stress Test at 6 Months | 92.2 percentage of participants |
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).
Time frame: 12 months
Population: 105 subjects were eligible for 12-month follow-up. 2 subjects either missed the visit or did not complete the PGI-I.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Altis SIS® | Percentage of Patients Responding Very Much Better or Much Better on PGI-I at 12 Months | 89.3 percentage of participants |
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).
Time frame: 6 months
Population: 109 subjects were eligible for 6-month follow-up. 4 subjects either missed the visit or did not complete the PGI-I.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Altis SIS® | Percentage of Patients Responding Very Much Better or Much Better on PGI-I at 6 Months | 87.6 percentage of participants |