Trial Outcomes & Findings for The Altis® Single Incision Sling System for Female Stress Urinary Incontinence Study (NCT NCT01272284)

NCT ID: NCT01272284

Last Updated: 2021-02-11

Results Overview

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%.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 113 participants
• Primary outcome timeframe: 6 months (compared to baseline)
• Results posted on: 2021-02-11

Participant Flow

Women with documented stress urinary incontinence (SUI) who met enrollment criteria

Participant milestones

Measure	Altis® SIS Participants implanted with Altis® Single Incision Sling
3-month Follow-up Visit STARTED	113
3-month Follow-up Visit COMPLETED	112
3-month Follow-up Visit NOT COMPLETED	1
6-month Follow-up Visit STARTED	112
6-month Follow-up Visit COMPLETED	109
6-month Follow-up Visit NOT COMPLETED	3
12-month Follow-up Visit STARTED	109
12-month Follow-up Visit COMPLETED	105
12-month Follow-up Visit NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Altis® Single Incision Sling System for Female Stress Urinary Incontinence Study

Baseline characteristics by cohort

Measure	Altis® SIS n=113 Participants Participants implanted with Altis® Single Incision Sling
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	86 Participants n=5 Participants
Age, Categorical >=65 years	27 Participants n=5 Participants
Age, Continuous	54.5 years STANDARD_DEVIATION 14.0 • n=5 Participants
Sex: Female, Male Female	113 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	93 participants n=5 Participants
Region of Enrollment Canada	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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%.

Outcome measures

Measure	Altis SIS® n=103 Participants Participants implanted with Altis® Single Incision Sling
Percentage of Participants With at Least 50% Reduction in 24-hour Pad Weight From Baseline to 6 Months	85.4 percentage of participants

SECONDARY outcome

Timeframe: 6 months

Population: 109 subjects were eligible for 6-month follow-up. 6 subjects missed either the visit or the cough stress test.

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.

Outcome measures

Measure	Altis SIS® n=103 Participants Participants implanted with Altis® Single Incision Sling
Percentage of Participants With Negative Cough Stress Test at 6 Months	92.2 percentage of participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Altis SIS® n=92 Participants Participants implanted with Altis® Single Incision Sling
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 outcome

Timeframe: 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.

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%.

Outcome measures

Measure	Altis SIS® n=105 Participants Participants implanted with Altis® Single Incision Sling
Percentage of Participants With at Least 50% Improvement in UDI-6 Score From Baseline to 6 Months	88.6 percentage of participants

SECONDARY outcome

Timeframe: 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.

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%.

Outcome measures

Measure	Altis SIS® n=104 Participants Participants implanted with Altis® Single Incision Sling
Percentage of Participants With at Least 50% Improvement in IIQ-7 From Baseline to 6 Months	93.3 percentage of participants

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Measure	Altis SIS® n=105 Participants Participants implanted with Altis® Single Incision Sling
Percentage of Patients Responding "Very Much Better" or "Much Better" on PGI-I at 6 Months	87.6 percentage of participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Altis SIS® n=101 Participants Participants implanted with Altis® Single Incision Sling
Percentage of Participants With at Least 50% Reduction in 24-hour Pad Weight From Baseline to 12 Months	90.1 percentage of participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Altis SIS® n=101 Participants Participants implanted with Altis® Single Incision Sling
Percentage of Participants With Negative Cough Stress Test at 12 Months	90.1 percentage of participants

SECONDARY outcome

Timeframe: 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.

Success defined as at least a 50% improvement from baseline to 12 months, as measured by validated Urinary Distress Inventory Short Form (UDI-6)

Outcome measures

Measure	Altis SIS® n=103 Participants Participants implanted with Altis® Single Incision Sling
Percentage of Participants With at Least 50% Improvement in UDI-6 Score From Baseline to 12 Months	89.3 percentage of participants

SECONDARY outcome

Timeframe: 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.

Success defined as at least a 50% improvement from baseline to 12 months, as measured by validated Incontinence Impact Questionnaire Short Form (IIQ-7)

Outcome measures

Measure	Altis SIS® n=103 Participants Participants implanted with Altis® Single Incision Sling
Percentage of Participants With at Least 50% Improvement in IIQ-7 From Baseline to 12 Months	90.3 percentage of participants

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Measure	Altis SIS® n=103 Participants Participants implanted with Altis® Single Incision Sling
Percentage of Patients Responding "Very Much Better" or "Much Better" on PGI-I at 12 Months	89.3 percentage of participants

Adverse Events

Altis® SIS

Serious events: 3 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Measure	Altis® SIS n=113 participants at risk Participants implanted with Altis® Single Incision Sling
Surgical and medical procedures Hematoma	0.88% 1/113 • Number of events 1
Surgical and medical procedures Mesh extrusion	0.88% 1/113 • Number of events 1

Other adverse events

Measure	Altis® SIS n=113 participants at risk Participants implanted with Altis® Single Incision Sling
Surgical and medical procedures Non-pelvic pain	8.0% 9/113 • Number of events 9

Additional Information

Clinical Trials Manager

Coloplast Corp

Phone: 612-302-4990

Email: usdibe@coloplast.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60