Clinical Evaluation of Ajust™ in Stress Urinary Incontinence (CEASe)

• ClinicalTrials.gov Identifier: NCT01290796
• Recruitment Status: Completed
• First Posted: February 7, 2011
• Results First Posted: May 12, 2014
• Last Update Posted: March 27, 2017
• Sponsor: C. R. Bard
• Information provided by (Responsible Party): C. R. Bard

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	Not Applicable

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 (Clinical Trial)
• 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: January 2011
• Actual Primary Completion Date: June 2013
• Actual Study Completion Date: October 2015

Arms and Interventions

Arm

Intervention/treatment

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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

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

United States, California

Clark Center for Urogynecology

Newport Beach, California, United States, 92663

United States, Michigan

Female Pelvic & Urogynecology Institute of Michigan, Grand Rapids Womens Health

Grand Rapids, Michigan, United States, 49503

United States, New Jersey

Princeton Urogynecology

Princeton, New Jersey, United States, 08540

United States, Pennsylvania

Institute for Female Pelvic Medicine and Reconstructive Surgery

Allentown, Pennsylvania, United States, 18105

Manjon Gynecology

Harrisburg, Pennsylvania, United States, 17110

United States, South Carolina

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

More Information

• Responsible Party: C. R. Bard
• ClinicalTrials.gov Identifier: NCT01290796
• Other Study ID Numbers: BMD-2112
• First Posted: February 7, 2011
• Results First Posted: May 12, 2014
• Last Update Posted: March 27, 2017
• Last Verified: February 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

Urinary Incontinence; Enuresis; Urinary Incontinence, Stress; Urination Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Behavioral Symptoms; Elimination Disorders; Mental Disorders