Trial Outcomes & Findings for Clinical Evaluation of Ajust™ in Stress Urinary Incontinence (NCT NCT01290796)

NCT ID: NCT01290796

Last Updated: 2017-03-27

Results Overview

Percentage of patients who are free of stress urinary incontinence, as assessed by a negative (-) Cough Stress Test (CST) and no surgical retreatment, at the 12 month study visit.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 153 participants
• Primary outcome timeframe: 12-months post surgical procedure
• Results posted on: 2017-03-27

Participant Flow

Participant milestones

Measure	Ajust Adjustable Single-Incision Sling Urinary incontinence sling Ajust Adjustable Single-Incision Sling: The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment.
Overall Study STARTED	153
Overall Study COMPLETED	123
Overall Study NOT COMPLETED	30

Reasons for withdrawal

Measure	Ajust Adjustable Single-Incision Sling Urinary incontinence sling Ajust Adjustable Single-Incision Sling: The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment.
Overall Study Lost to Follow-up	21
Overall Study Withdrawal by Subject	4
Overall Study Physician Decision	2
Overall Study Secondary Surgical Intervention	2
Overall Study Withdrawal by Sponsor	1

Baseline Characteristics

Clinical Evaluation of Ajust™ in Stress Urinary Incontinence

Baseline characteristics by cohort

Measure	Ajust Adjustable Single-Incision Sling n=153 Participants Urinary incontinence sling Ajust Adjustable Single-Incision Sling: The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment.
Age, Continuous	51.4 years STANDARD_DEVIATION 10.3 • n=5 Participants
Age, Customized <65 years	129 participants n=5 Participants
Age, Customized >=65 years	24 participants n=5 Participants
Sex: Female, Male Female	153 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	143 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	149 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	153 participants n=5 Participants

PRIMARY outcome

Timeframe: 12-months post surgical procedure

Percentage of patients who are free of stress urinary incontinence, as assessed by a negative (-) Cough Stress Test (CST) and no surgical retreatment, at the 12 month study visit.

Outcome measures

Measure

Ajust Adjustable Single-Incision Sling n=153 Participants Urinary incontinence sling Ajust Adjustable Single-Incision Sling: The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment.

Percentage of Patients Free of Stress Urinary Incontinence

92.8 percentage of participants Interval 87.1 to 96.5

PRIMARY outcome

Timeframe: 12-months post procedure

Improvement was defined as a 25-point decrease (improvement) in Urinary Distress Inventory (UDI-6) score (Range: 0 - 100).

Outcome measures

Measure

Ajust Adjustable Single-Incision Sling n=153 Participants Urinary incontinence sling Ajust Adjustable Single-Incision Sling: The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment.

Percentage of Subjects Who Showed Improvement in Self-reported SUI Symptoms at 12 Months

79.3 percentage of participants Interval 71.4 to 85.8

SECONDARY outcome

Timeframe: 1 day

Percentage of Patients with Procedure and/or Device Related Adverse Events During the Operative Procedure

Outcome measures

Measure

Ajust Adjustable Single-Incision Sling n=153 Participants Urinary incontinence sling Ajust Adjustable Single-Incision Sling: The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment.

Operative, Perioperative and Long-Term Complications During Operative Procedure

11.8 percentage of participants Interval 7.1 to 18.0

SECONDARY outcome

Timeframe: 1-15 days

Percentage of Patients with Procedure and/or Device Related Adverse Events Perioperatively

Outcome measures

Measure

Ajust Adjustable Single-Incision Sling n=153 Participants Urinary incontinence sling Ajust Adjustable Single-Incision Sling: The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment.

Operative, Perioperative and Long-Term Complications Perioperatively

2.6 percentage of participants Interval 0.7 to 6.6

SECONDARY outcome

Timeframe: Day 15 through 36-months post procedure

Percentage of Patients with Procedure and/or Device Related Adverse Events through 36 months

Outcome measures

Measure

Ajust Adjustable Single-Incision Sling n=153 Participants Urinary incontinence sling Ajust Adjustable Single-Incision Sling: The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment.

Operative, Perioperative and Long-term Complications Through 36 Months

8.5 percentage of participants Interval 4.6 to 14.1

SECONDARY outcome

Timeframe: 0-7 days

Mean change in Overall McCarthy Surgical Pain Scale from Day 0 to Day 7. McCarthy Pain Scale is a 50 millimeter line with "No Pain Sensation" noted at the 0 mm mark and "Most Intense Pain Imaginable" noted at the 50 mm mark. Each day, subjects are asked to mark their level of pain somewhere along the line. Change in pain level is reported in millimeters.

Outcome measures

Measure

Ajust Adjustable Single-Incision Sling n=153 Participants Urinary incontinence sling Ajust Adjustable Single-Incision Sling: The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment.

Change in Post-operative Pain

-79.7 millimeters Standard Deviation 92.7

SECONDARY outcome

Timeframe: 0-36 Months

Improvement was defined as a 25-point decrease (improvement) in Urinary Distress Inventory (UDI-6) score (Range: 0 - 100).

Outcome measures

Measure

Ajust Adjustable Single-Incision Sling n=153 Participants Urinary incontinence sling Ajust Adjustable Single-Incision Sling: The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment.

Percentage of Subjects Who Showed Improvement in Self-reported SUI Symptoms at 36 Months

55.3 percentage of participants Interval 46.1 to 64.3

SECONDARY outcome

Timeframe: 0-12 months

Mean change in overall IIQ-7 summary score (range 0 - 100). Scores on the IIQ-7 range from 0 (best outcome) to 100 (worst outcome). For this outcome measure, IIQ-7 at baseline was compared to that administered at 12-months post-surgery.

Outcome measures

Measure

Ajust Adjustable Single-Incision Sling n=153 Participants Urinary incontinence sling Ajust Adjustable Single-Incision Sling: The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment.

Change in Incontinent Impact Questionnaire at 12 Months

-32.9 units on a scale Standard Deviation 23.5

SECONDARY outcome

Timeframe: 0-36 months

Mean change in overall IIQ-7 summary score (range 0 - 100). Scores on the IIQ-7 range from 0 (best outcome) to 100 (worst outcome). For this outcome measure, IIQ-7 at baseline was compared to that administered at 36-months post-surgery.

Outcome measures

Measure

Ajust Adjustable Single-Incision Sling n=153 Participants Urinary incontinence sling Ajust Adjustable Single-Incision Sling: The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment.

Change in Incontinent Impact Questionnaire at 36 Months

-29.7 units on a scale Standard Deviation 22.2

SECONDARY outcome

Timeframe: 0-12 Months

Population: Patients who completed 12 month evaulations

Patient satisfaction was assessed using the Patient Global Impression of Improvement (PGII) questionnaire. Patients were considered to be "satisfied" if they felt that their urinary tract condition was "very much better" or "much better" than how it felt before the surgery.

Outcome measures

Measure

Ajust Adjustable Single-Incision Sling n=136 Participants Urinary incontinence sling Ajust Adjustable Single-Incision Sling: The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment.

Percentage of Patients With Impression of Improvement With Procedure at 12 Months

94.9 percentage of participants

SECONDARY outcome

Timeframe: 0-36 Months

Population: Patients who completed 36 month evaulations

Patient satisfaction was assessed using the Patient Global Impression of Improvement (PGII) questionnaire. Patients were considered to be "satisfied" if they felt that their urinary tract conditio0n was "very much better" or "much better" than how it felt before the surgery.

Outcome measures

Measure

Ajust Adjustable Single-Incision Sling n=123 Participants Urinary incontinence sling Ajust Adjustable Single-Incision Sling: The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment.

Percentage of Patients With Impression of Improvement With Procedure at 36 Months

81.3 percentage of participants

Adverse Events

Ajust Adjustable Single-Incision Sling

Serious events: 2 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Measure	Ajust Adjustable Single-Incision Sling n=153 participants at risk Urinary incontinence sling Ajust Adjustable Single-Incision Sling: The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment.
Renal and urinary disorders Anuria	0.65% 1/153 • Number of events 1
General disorders Implant Site Pain	0.65% 1/153 • Number of events 1
Injury, poisoning and procedural complications Medical device complication	0.65% 1/153 • Number of events 1

Other adverse events

Measure

Ajust Adjustable Single-Incision Sling n=153 participants at risk Urinary incontinence sling Ajust Adjustable Single-Incision Sling: The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment.

Injury, poisoning and procedural complications Procedural Pain

10.5% 16/153 • Number of events 16

Additional Information

Jaime Ritter, MPH, CCRP, CIC

Bard Medical Division

Phone: 770-784-6437

Email: jaime.ritter@crbard.com

Results disclosure agreements

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