CEASe: Clinical Evaluation of Ajust™ in Stress Urinary Incontinence

• Sponsor: C. R. Bard (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01290796
• Collaborator: (none)
• Enrollment: 153
• Locations: 6
• Arm: 1
• Duration (Months): 57
• Patients Per Site: 25.5
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the overall effectiveness of the Ajust Adjustable Single-Incision Sling in the surgical treatment of female stress urinary incontinence.

Condition or Disease	Intervention/Treatment	Phase
Female Stress Urinary Incontinence	Device: Ajust Adjustable Single-Incision Sling	N/A

Detailed Description

Urinary incontinence (UI), or the complaint of any involuntary loss of urine, ranges in severity from the occasional leaking urine during actions resulting in increased abdominal pressure (coughing, sneezing, laughing, exercise, etc.) to sudden, unpredictable strong urges to void. Female stress urinary incontinence (SUI) is attributed to a weakening of the pelvic floor muscles.

A recent review of literature describing the prevalence of UI calculated the median prevalence of female UI to be 27.6% (4.8-58.4%), with the prevalence of significant incontinence increasing with age. The prevalent cause of UI was further categorized into stress (50%), mixed (32%) and urge (14%).

Nonsurgical treatment of female SUI has traditionally been limited to alpha-adrenergic agonists and estrogens, pelvic floor exercises, biofeedback, electrical stimulation and behavior modification1. Options for surgical treatment consists of periurethral injections of bulking agents, transvaginal suspensions, retropubic suspensions, slings and sphincter prostheses.

The Ajust™ Adjustable Single-Incision Sling is a fully adjustable single-incision sling that anchors in the transobturator membranes, anatomically sufficient spaces for support of the urethra.

Study Design

• Study Type: Interventional
• Actual Enrollment: 153 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Evaluation of Ajust™ in Stress Urinary Incontinence (CEASe)
• Study Start Date: Jan 1, 2011
• Actual Primary Completion Date: Jun 1, 2013
• Actual Study Completion Date: Oct 1, 2015

Arms and Interventions

Arm

Intervention/Treatment

Other: Ajust Adjustable Single-Incision Sling Urinary incontinence sling

Device: 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.

Outcome Measures

Primary Outcome Measures

1. Percentage of Patients Free of Stress Urinary Incontinence [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.

2. Percentage of Subjects Who Showed Improvement in Self-reported SUI Symptoms at 12 Months [12-months post procedure]

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

Secondary Outcome Measures

1. Operative, Perioperative and Long-Term Complications During Operative Procedure [1 day]

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

2. Operative, Perioperative and Long-Term Complications Perioperatively [1-15 days]

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

3. Operative, Perioperative and Long-term Complications Through 36 Months [Day 15 through 36-months post procedure]

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

4. Change in Post-operative Pain [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.

5. Percentage of Subjects Who Showed Improvement in Self-reported SUI Symptoms at 36 Months [0-36 Months]

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

6. Change in Incontinent Impact Questionnaire at 12 Months [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.

7. Change in Incontinent Impact Questionnaire at 36 Months [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.

8. Percentage of Patients With Impression of Improvement With Procedure at 12 Months [0-12 Months]

   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.

9. Percentage of Patients With Impression of Improvement With Procedure at 36 Months [0-36 Months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Female, age at least 18 years

• Have signed an Informed Consent Form

• Has been diagnosed with stress urinary incontinence as documented by: a minimum 30-degree urethral deflection, considered to be a candidate for transobturator repair by consulting surgeon (investigator), has a positive CST

• Desires surgical correction of SUI using the Ajust™ Adjustable Single-Incision Sling

Exclusion Criteria:

• Patient is actively participating in any other genitourinary clinical trial of an experimental drug or device

• Patient is known to be pregnant or desiring future childbearing

• Patient has a known urinary tract infection, or known infection in the operative field at the time of device implantation

• Patient is unable to have their anticoagulation therapy suspended for the completion of the surgical procedure

• Patient requires concurrent correction of pelvic organ prolapse

• Patient has a history of previous sling procedure

• Patient has known history of detrusor overactivity demonstrated by urodynamics

• Patient has known urinary retention

• Patient has a current genitourinary fistula or urinary diverticulum

• Patient has a prior history of pelvic radiation

• Patient has a MESA urge symptom score (% of total possible urge score) that is greater than their MESA stress symptom score (% of total possible stress score)

• Any condition in the opinion of the Investigator that would preclude the use of the Ajust™ Adjustable Single-Incision Sling, or preclude the subject from completing the follow-up requirements

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clark Center for Urogynecology	Newport Beach	California	United States	92663
2	Female Pelvic & Urogynecology Institute of Michigan, Grand Rapids Womens Health	Grand Rapids	Michigan	United States	49503
3	Princeton Urogynecology	Princeton	New Jersey	United States	08540
4	Institute for Female Pelvic Medicine and Reconstructive Surgery	Allentown	Pennsylvania	United States	18105
5	Manjon Gynecology	Harrisburg	Pennsylvania	United States	17110
6	Southern Uroynecology	West Columbia	South Carolina	United States	29169

Sponsors and Collaborators

• C. R. Bard

Investigators

• Principal Investigator: Vincent Lucente, MD, Institute for Female Pelvic Medicine and Reconstructive Surgery

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: C. R. Bard
• ClinicalTrials.gov Identifier: NCT01290796
• Other Study ID Numbers: BMD-2112
• First Posted: Feb 7, 2011
• Last Update Posted: Mar 27, 2017
• Last Verified: Feb 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress

Study Results

Participant Flow

Arm/Group Title	Ajust Adjustable Single-Incision Sling
Arm/Group Description	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.
Period Title: Overall Study
STARTED	153
COMPLETED	123
NOT COMPLETED	30

Baseline Characteristics

Arm/Group Title	Ajust Adjustable Single-Incision Sling
Arm/Group Description	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 Participants	153
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	51.4 (10.3)
Age, Customized (participants) [Number]
<65 years	129 84.3%
>=65 years	24 15.7%
Sex: Female, Male (Count of Participants)
Female	153 100%
Male	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	5 3.3%
Native Hawaiian or Other Pacific Islander	2 1.3%
Black or African American	3 2%
White	143 93.5%
More than one race	0 0%
Unknown or Not Reported	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	4 2.6%
Not Hispanic or Latino	149 97.4%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	153 100%

Outcome Measures

1. Primary Outcome

Title	Percentage of Patients Free of Stress Urinary Incontinence
Description	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.
Time Frame	12-months post surgical procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ajust Adjustable Single-Incision Sling
Arm/Group Description	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.
Measure Participants	153
Number (95% Confidence Interval) [percentage of participants]	92.8 60.7%

2. Primary Outcome

Title	Percentage of Subjects Who Showed Improvement in Self-reported SUI Symptoms at 12 Months
Description	Improvement was defined as a 25-point decrease (improvement) in Urinary Distress Inventory (UDI-6) score (Range: 0 - 100).
Time Frame	12-months post procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ajust Adjustable Single-Incision Sling
Arm/Group Description	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.
Measure Participants	153
Number (95% Confidence Interval) [percentage of participants]	79.3 51.8%

3. Secondary Outcome

Title	Operative, Perioperative and Long-Term Complications During Operative Procedure
Description	Percentage of Patients with Procedure and/or Device Related Adverse Events During the Operative Procedure
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ajust Adjustable Single-Incision Sling
Arm/Group Description	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.
Measure Participants	153
Number (95% Confidence Interval) [percentage of participants]	11.8 7.7%

4. Secondary Outcome

Title	Operative, Perioperative and Long-Term Complications Perioperatively
Description	Percentage of Patients with Procedure and/or Device Related Adverse Events Perioperatively
Time Frame	1-15 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ajust Adjustable Single-Incision Sling
Arm/Group Description	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.
Measure Participants	153
Number (95% Confidence Interval) [percentage of participants]	2.6 1.7%

5. Secondary Outcome

Title	Operative, Perioperative and Long-term Complications Through 36 Months
Description	Percentage of Patients with Procedure and/or Device Related Adverse Events through 36 months
Time Frame	Day 15 through 36-months post procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ajust Adjustable Single-Incision Sling
Arm/Group Description	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.
Measure Participants	153
Number (95% Confidence Interval) [percentage of participants]	8.5 5.6%

6. Secondary Outcome

Title	Change in Post-operative Pain
Description	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.
Time Frame	0-7 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ajust Adjustable Single-Incision Sling
Arm/Group Description	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.
Measure Participants	153
Mean (Standard Deviation) [millimeters]	-79.7 (92.7)

7. Secondary Outcome

Title	Percentage of Subjects Who Showed Improvement in Self-reported SUI Symptoms at 36 Months
Description	Improvement was defined as a 25-point decrease (improvement) in Urinary Distress Inventory (UDI-6) score (Range: 0 - 100).
Time Frame	0-36 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ajust Adjustable Single-Incision Sling
Arm/Group Description	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.
Measure Participants	153
Number (95% Confidence Interval) [percentage of participants]	55.3 36.1%

8. Secondary Outcome

Title	Change in Incontinent Impact Questionnaire at 12 Months
Description	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.
Time Frame	0-12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ajust Adjustable Single-Incision Sling
Arm/Group Description	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.
Measure Participants	153
Mean (Standard Deviation) [units on a scale]	-32.9 (23.5)

9. Secondary Outcome

Title	Change in Incontinent Impact Questionnaire at 36 Months
Description	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.
Time Frame	0-36 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ajust Adjustable Single-Incision Sling
Arm/Group Description	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.
Measure Participants	153
Mean (Standard Deviation) [units on a scale]	-29.7 (22.2)

10. Secondary Outcome

Title	Percentage of Patients With Impression of Improvement With Procedure at 12 Months
Description	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.
Time Frame	0-12 Months

Outcome Measure Data

Analysis Population Description

Patients who completed 12 month evaulations

Arm/Group Title	Ajust Adjustable Single-Incision Sling
Arm/Group Description	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.
Measure Participants	136
Number [percentage of participants]	94.9 62%

11. Secondary Outcome

Title	Percentage of Patients With Impression of Improvement With Procedure at 36 Months
Description	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.
Time Frame	0-36 Months

Outcome Measure Data

Analysis Population Description

Patients who completed 36 month evaulations

Arm/Group Title	Ajust Adjustable Single-Incision Sling
Arm/Group Description	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.
Measure Participants	123
Number [percentage of participants]	81.3 53.1%

Adverse Events

Arm/Group Title	Ajust Adjustable Single-Incision Sling
Arm/Group Description	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.
All Cause Mortality
	Ajust Adjustable Single-Incision Sling
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Ajust Adjustable Single-Incision Sling
	Affected / at Risk (%)	# Events
Total	2/153 (1.3%)
General disorders
Implant Site Pain	1/153 (0.7%)	1
Injury, poisoning and procedural complications
Medical device complication	1/153 (0.7%)	1
Renal and urinary disorders
Anuria	1/153 (0.7%)	1
Other (Not Including Serious) Adverse Events
	Ajust Adjustable Single-Incision Sling
	Affected / at Risk (%)	# Events
Total	16/153 (10.5%)
Injury, poisoning and procedural complications
Procedural Pain	16/153 (10.5%)	16

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.