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

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

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.

Study Overview

• Status: Completed
• Conditions: Female Stress Urinary Incontinence
• Intervention / Treatment: Device: Ajust Adjustable Single-Incision Sling

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 Type: Interventional
• Enrollment (Actual): 153
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Newport Beach, California, United States, 92663
      • Clark Center for Urogynecology
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Female Pelvic & Urogynecology Institute of Michigan, Grand Rapids Womens Health
  • New Jersey
    • Princeton, New Jersey, United States, 08540
      • Princeton Urogynecology
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18105
      • Institute for Female Pelvic Medicine and Reconstructive Surgery
    • Harrisburg, Pennsylvania, United States, 17110
      • Manjon Gynecology
  • South Carolina
    • West Columbia, South Carolina, United States, 29169
      • Southern Uroynecology

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative, Perioperative and Long-Term Complications During Operative Procedure	Percentage of Patients with Procedure and/or Device Related Adverse Events During the Operative Procedure	1 day
Operative, Perioperative and Long-Term Complications Perioperatively	Percentage of Patients with Procedure and/or Device Related Adverse Events Perioperatively	1-15 days
Operative, Perioperative and Long-term Complications Through 36 Months	Percentage of Patients with Procedure and/or Device Related Adverse Events through 36 months	Day 15 through 36-months post procedure
Change in Post-operative Pain	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.	0-7 days
Percentage of Subjects Who Showed Improvement in Self-reported SUI Symptoms at 36 Months	Improvement was defined as a 25-point decrease (improvement) in Urinary Distress Inventory (UDI-6) score (Range: 0 - 100).	0-36 Months
Change in Incontinent Impact Questionnaire at 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.	0-12 months
Change in Incontinent Impact Questionnaire at 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.	0-36 months
Percentage of Patients With Impression of Improvement With Procedure at 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.	0-12 Months
Percentage of Patients With Impression of Improvement With Procedure at 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.	0-36 Months

Collaborators and Investigators

• Sponsor: C. R. Bard
• Investigators: Principal Investigator: Vincent Lucente, MD, Institute for Female Pelvic Medicine and Reconstructive Surgery

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: February 4, 2011
• First Submitted That Met QC Criteria: February 4, 2011
• First Posted (Estimate): February 7, 2011

Study Record Updates

• Last Update Posted (Actual): March 27, 2017
• Last Update Submitted That Met QC Criteria: February 7, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: BMD-2112

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO