Clinical Evaluation of Ajust™ in Stress Urinary Incontinence (CEASe)
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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) |
- 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 ]
- Operative, perioperative and long-term complications [ Time Frame: Day 0 through 36-months post procedure ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 150 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | June 2015 |
| Estimated 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 |
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| 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 | |
| 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 |
| Last Updated: | August 1, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Urinary Incontinence Urinary Incontinence, Stress Urination Disorders |
Urologic Diseases Urological Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013