Female Stress Urinary Incontinence
Conditions
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.
Interventions
DEVICEAjust 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.
Sponsors
C. R. Bard
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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). |
| 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 |
| 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. |
| 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. |
| 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. |
| Operative, Perioperative and Long-Term Complications Perioperatively | 1-15 days | Percentage of Patients with Procedure and/or Device Related Adverse Events Perioperatively |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 153 |
| Total | 153 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 21 |
| Overall Study | Physician Decision | 2 |
| Overall Study | Secondary Surgical Intervention | 2 |
| Overall Study | Withdrawal by Sponsor | 1 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Ajust Adjustable Single-Incision Sling |
|---|---|
| Age, Continuous | 51.4 years STANDARD_DEVIATION 10.3 |
| Age, Customized <65 years | 129 participants |
| Age, Customized >=65 years | 24 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 149 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 143 Participants |
| Region of Enrollment United States | 153 participants |
| Sex: Female, Male Female | 153 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 16 / 153 |
| serious Total, serious adverse events | 2 / 153 |
Outcome results
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.
Time frame: 12-months post surgical procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ajust Adjustable Single-Incision Sling | Percentage of Patients Free of Stress Urinary Incontinence | 92.8 percentage of 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).
Time frame: 12-months post procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ajust Adjustable Single-Incision Sling | Percentage of Subjects Who Showed Improvement in Self-reported SUI Symptoms at 12 Months | 79.3 percentage of participants |
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.
Time frame: 0-12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ajust Adjustable Single-Incision Sling | Change in Incontinent Impact Questionnaire at 12 Months | -32.9 units on a scale | Standard Deviation 23.5 |
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.
Time frame: 0-36 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ajust Adjustable Single-Incision Sling | Change in Incontinent Impact Questionnaire at 36 Months | -29.7 units on a scale | Standard Deviation 22.2 |
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.
Time frame: 0-7 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ajust Adjustable Single-Incision Sling | Change in Post-operative Pain | -79.7 millimeters | Standard Deviation 92.7 |
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
Time frame: 1 day
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ajust Adjustable Single-Incision Sling | Operative, Perioperative and Long-Term Complications During Operative Procedure | 11.8 percentage of participants |
Secondary
Operative, Perioperative and Long-Term Complications Perioperatively
Percentage of Patients with Procedure and/or Device Related Adverse Events Perioperatively
Time frame: 1-15 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ajust Adjustable Single-Incision Sling | Operative, Perioperative and Long-Term Complications Perioperatively | 2.6 percentage of participants |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ajust Adjustable Single-Incision Sling | Operative, Perioperative and Long-term Complications Through 36 Months | 8.5 percentage of participants |
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.
Time frame: 0-12 Months
Population: Patients who completed 12 month evaulations
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ajust Adjustable Single-Incision Sling | Percentage of Patients With Impression of Improvement With Procedure at 12 Months | 94.9 percentage of participants |
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.
Time frame: 0-36 Months
Population: Patients who completed 36 month evaulations
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ajust Adjustable Single-Incision Sling | Percentage of Patients With Impression of Improvement With Procedure at 36 Months | 81.3 percentage of participants |
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).
Time frame: 0-36 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ajust Adjustable Single-Incision Sling | Percentage of Subjects Who Showed Improvement in Self-reported SUI Symptoms at 36 Months | 55.3 percentage of participants |