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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
C. R. Bard
ClinicalTrials.gov Identifier:
NCT01290796
First received: February 4, 2011
Last updated: May 9, 2014
Last verified: May 2014
  Purpose

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 Intervention
Female Stress Urinary Incontinence
Device: Ajust Adjustable Single-Incision Sling

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Ajust™ in Stress Urinary Incontinence (CEASe)

Resource links provided by NLM:


Further study details as provided by C. R. Bard:

Primary Outcome Measures:
  • Percentage of Patients Free of Stress Urinary Incontinence [ Time Frame: 12-months post surgical procedure ] [ Designated as safety issue: No ]
    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.

  • Percentage of Patients Who Showed Improvement in Self-reported SUI Symptoms [ Time Frame: 12-months post procedure ] [ Designated as safety issue: No ]
    Improvement was defined as a 25-point decrease (improvement) in Urinary Distress Inventory (UDI-6) score (Range: 0 - 100).


Secondary Outcome Measures:
  • Operative, Perioperative and Long-term Complications [ Time Frame: Day 0 through 36-months post procedure ] [ Designated as safety issue: Yes ]

Enrollment: 153
Study Start Date: January 2011
Estimated Study Completion Date: June 2015
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01290796

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

No publications provided

Responsible Party: C. R. Bard
ClinicalTrials.gov Identifier: NCT01290796     History of Changes
Other Study ID Numbers: BMD-2112
Study First Received: February 4, 2011
Results First Received: April 10, 2014
Last Updated: May 9, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Lower Urinary Tract Symptoms
Signs and Symptoms
Urination Disorders
Urologic Diseases
Urological Manifestations

ClinicalTrials.gov processed this record on October 20, 2014