Clinical Evaluation of Ajust™ in Stress Urinary Incontinence

C. R. Bard153 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

153

Conditions

Female Stress Urinary Incontinence

Interventions

Ajust Adjustable Single-Incision SlingDEVICE

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (6)

Clark Center for Urogynecology

Newport Beach, California, United States

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

Grand Rapids, Michigan, United States

Princeton Urogynecology

Princeton, New Jersey, United States

Institute for Female Pelvic Medicine and Reconstructive Surgery

Allentown, Pennsylvania, United States

Outcomes

Primary Outcomes

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.

Time frame: 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).

Time frame: 12-months post procedure

Secondary Outcomes

Operative, Perioperative and Long-Term Complications During Operative Procedure

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

Time frame: 1 day

Operative, Perioperative and Long-Term Complications Perioperatively

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

Time frame: 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

Time frame: 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.

Data from ClinicalTrials.gov

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