Clinical Evaluation of Ajust™ in Stress Urinary Incontinence

Not Applicable

Completed

Conditions: Female Stress Urinary Incontinence

Interventions: Device: Ajust Adjustable Single-Incision Sling

Registration Number: NCT01290796

Lead Sponsor: C. R. Bard

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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 153

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ajust Adjustable Single-Incision Sling	Ajust Adjustable Single-Incision Sling	Urinary incontinence sling

Primary Outcome Measures

Name	Time	Method
Percentage of Patients Free of Stress Urinary Incontinence	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.
Percentage of Subjects Who Showed Improvement in Self-reported SUI Symptoms at 12 Months	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

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

Trial Locations

Locations (6): Institute for Female Pelvic Medicine and Reconstructive Surgery
🇺🇸
Allentown, Pennsylvania, United States
Princeton Urogynecology
🇺🇸
Princeton, New Jersey, United States
Clark Center for Urogynecology
🇺🇸
Newport Beach, California, United States
Female Pelvic & Urogynecology Institute of Michigan, Grand Rapids Womens Health
🇺🇸
Grand Rapids, Michigan, United States
Manjon Gynecology
🇺🇸
Harrisburg, Pennsylvania, United States
Southern Uroynecology
🇺🇸
West Columbia, South Carolina, United States