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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ajust Adjustable Single-Incision Sling | Other | Urinary incontinence sling |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ajust Adjustable Single-Incision Sling | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vincent Lucente, MD | Institute for Female Pelvic Medicine and Reconstructive Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clark Center for Urogynecology | Newport Beach | California | 92663 | United States | ||
| Female Pelvic & Urogynecology Institute of Michigan, Grand Rapids Womens Health |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ajust Adjustable Single-Incision Sling | Urinary incontinence sling 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ajust Adjustable Single-Incision Sling | Urinary incontinence sling 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | 12-months post surgical procedure |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ajust Adjustable Single-Incision Sling | Urinary incontinence sling 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anuria | Renal and urinary disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Procedural Pain | Injury, poisoning and procedural complications |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jaime Ritter, MPH, CCRP, CIC | Bard Medical Division | 770-784-6437 | jaime.ritter@crbard.com |
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|
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 |
| Grand Rapids |
| Michigan |
| 49503 |
| United States |
| Princeton Urogynecology | Princeton | New Jersey | 08540 | United States |
| Institute for Female Pelvic Medicine and Reconstructive Surgery | Allentown | Pennsylvania | 18105 | United States |
| Manjon Gynecology | Harrisburg | Pennsylvania | 17110 | United States |
| Southern Uroynecology | West Columbia | South Carolina | 29169 | United States |
| Secondary Surgical Intervention |
|
| Withdrawal by Sponsor |
|
| years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | 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). | Posted | Number | 95% Confidence Interval | percentage of participants | 12-months post procedure |
|
|
|
| Secondary | Operative, Perioperative and Long-Term Complications During Operative Procedure | Percentage of Patients with Procedure and/or Device Related Adverse Events During the Operative Procedure | Posted | Number | 95% Confidence Interval | percentage of participants | 1 day |
|
|
|
| Secondary | Operative, Perioperative and Long-Term Complications Perioperatively | Percentage of Patients with Procedure and/or Device Related Adverse Events Perioperatively | Posted | Number | 95% Confidence Interval | percentage of participants | 1-15 days |
|
|
|
| Secondary | Operative, Perioperative and Long-term Complications Through 36 Months | Percentage of Patients with Procedure and/or Device Related Adverse Events through 36 months | Posted | Number | 95% Confidence Interval | percentage of participants | Day 15 through 36-months post procedure |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | millimeters | 0-7 days |
|
|
|
| Secondary | 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). | Posted | Number | 95% Confidence Interval | percentage of participants | 0-36 Months |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | 0-12 months |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | 0-36 months |
|
|
|
| Secondary | 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. | Patients who completed 12 month evaulations | Posted | Number | percentage of participants | 0-12 Months |
|
|
|
| Secondary | 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. | Patients who completed 36 month evaulations | Posted | Number | percentage of participants | 0-36 Months |
|
|
|
| 2 |
| 153 |
| 16 |
| 153 |
| Implant Site Pain | General disorders |
|
| Medical device complication | Injury, poisoning and procedural complications | Systematic Assessment |
|
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