Urinary Incontinence
Conditions
Keywords
urinary incontinence
Brief summary
The purpose of this study is to evaluate the safety and effectiveness of a minimally invasive surgical procedure in up to 160 implanted female patients in which two adjustable balloons (one on each side of the urethra) are implanted to treat urinary stress incontinence. The results will be analyzed to demonstrate the effects of the device as well as its associated risks. Therapeutic success will be based on whether the patients demonstrate at least a one-grade (mean) reduction in the Stamey score at 12 months.
Detailed description
This is a multi-center, prospective, non randomized clinical trial comparing baseline data to the 12 month data. Urodynamic testing, pad weights and a direct visual stress test will be used to determine success along with the Stamey score.
Interventions
DEVICEACT (Adjustable Continence Therapy)
surgically implanted device
Sponsors
Uromedica
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
Yes
Inclusion criteria
* Women * 18 years or older * Diagnosed with stress urinary incontinence with or without urethral hypermobility * Willing to sign informed consent * Candidates for surgical intervention for stress incontinence * Negative urinalysis or urine culture within 2 weeks of implantation * Normal cystourethroscopy * Failed at least 6 months of previous treatments for stress urinary incontinence (e.g., exercise regimen, electrical stimulation, surgical procedures, etc.) * May have failed suspension or sling procedures
Exclusion criteria
* Pregnant or lactating * Life expectancy of less than one year * Insulin dependant diabetic * Auto-immune disease * Undergoing radiation therapy * Active urinary tract infection * Detrusor instability refractory to meds * Reduced bladder compliance * Significant bladder residual \>100mls * Bladder cancer * Unsuccessfully treated bladder stones * Current urethral stricture preventing the passage of a 24 French endoscope * Neurogenic bladder * Uncorrected rectocele, cystocele, urethrocele, enterocele or pelvic prolapse of Grade 3 or higher * Prior pelvic radiotherapy * Artificial urinary sphincter implanted
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Stamey Grade From Baseline to 12 Months. | Baseline to 12 months | The Stamey grade classifies the severity of stress incontinence in four possible grades from 0-3. Grade 0: no leaking, Grade 1: loss of urine with sudden increases of abdominal pressure: e.g. coughing, sneezing or laughing, Grade 2: loss of urine with lesser degrees of stress: e.g. walking or standing up, and Grade 3: loss of urine without any relation to physical activity or position, e.g. while lying in bed. The primary end point at 12 months is a mean change in Stamey Grade from baseline of greater than or equal to -1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incontinence Impact Questionnaire (IIQ-7) | Baseline to 12 months | Incontinence Impact Questionnaire (IIQ-7) change from baseline to 12 months. Scores range from 0-100. 0 being impact from incontinence, 100 being most impacted from incontinence. |
| Urinary Distress Inventory (UDI-6) | Baseline to 12 months | Change on Urinary Distress Inventory (UDI-6) questionnaire from baseline to 12 months. 0 being not distressed, 100 being very distressed. |
| Incontinence Quality of Life (IQoL) Questionnaire | Baseline to 12 months | Change on Incontinence Quality of Life (IQoL) Questionnaire from baseline to 12 months. 0 being lowest quality of life, 100 being highest quality of life. |
| Number of Pads Changed Per Day (Voiding Diary) | Baseline to 12 months | Change in Number of Pads Changed Per Day from baseline to 12 months. 0 pads changed a day being the best. |
| Provocative Pad Weight | Baseline to 12 months | Change in weight of pads (gm) from baseline to 12 months. 0 gm pad weight being the best. |
| Number of Incontinence Episodes Per Day (Voiding Diary) | Baseline to 12 months | Change in Number of Incontinence Episodes Per Day from baseline to 12 months. 0 being the best. |
Countries
Canada, United States
Participant flow
Recruitment details
A total of 10 investigational sites in US and 2 in Canada which were clinics,University hospitals or Research centers implanted patients in this study from the period 2001-2006.A total of 221 patients have been enrolled(218 with enrollment data) and 163 of those patients underwent an implant procedure.
Pre-assignment details
One patient was implanted and was considered a compassionate use patient that did not meet the enrollment criteria.This patient was not included in the efficacy and safety summaries and her adverse vents are recorded.Therefore the total number of implants for the analyses is 162.
Participants by arm
| Arm | Count |
|---|---|
| Experimental Open Label Study | 162 |
| Total | 162 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Baseline Failure | 59 |
| Overall Study | Death | 1 |
| Overall Study | Lost to Follow-up | 8 |
| Overall Study | Missed Followup | 4 |
| Overall Study | Permanently Explanted | 7 |
Baseline characteristics
| Characteristic | Experimental |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 123 Participants |
| Age, Categorical Between 18 and 65 years | 39 Participants |
| Age, Continuous | 67.6 years STANDARD_DEVIATION 11.6 |
| Region of Enrollment Canada | 25 participants |
| Region of Enrollment United States | 137 participants |
| Sex: Female, Male Female | 162 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 163 |
| other Total, other adverse events | 155 / 163 |
| serious Total, serious adverse events | 2 / 163 |
Outcome results
Primary
Change of Stamey Grade From Baseline to 12 Months.
The Stamey grade classifies the severity of stress incontinence in four possible grades from 0-3. Grade 0: no leaking, Grade 1: loss of urine with sudden increases of abdominal pressure: e.g. coughing, sneezing or laughing, Grade 2: loss of urine with lesser degrees of stress: e.g. walking or standing up, and Grade 3: loss of urine without any relation to physical activity or position, e.g. while lying in bed. The primary end point at 12 months is a mean change in Stamey Grade from baseline of greater than or equal to -1.
Time frame: Baseline to 12 months
Population: Intent to Treat
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Experimental | Change of Stamey Grade From Baseline to 12 Months. | -1.17 units on a scale |
Comparison: Wilcoxon's matched pairs signed ranks test was used to determine the significance of differences between scores at follow-up compared to pre-implant.p-value: <0.00195% CI: [-1.325, -1.003]Wilcoxon (Mann-Whitney)
Secondary
Incontinence Impact Questionnaire (IIQ-7)
Incontinence Impact Questionnaire (IIQ-7) change from baseline to 12 months. Scores range from 0-100. 0 being impact from incontinence, 100 being most impacted from incontinence.
Time frame: Baseline to 12 months
Population: Intent to Treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental | Incontinence Impact Questionnaire (IIQ-7) | -26.53 units on a scale | Standard Deviation 33.07 |
Secondary
Incontinence Quality of Life (IQoL) Questionnaire
Change on Incontinence Quality of Life (IQoL) Questionnaire from baseline to 12 months. 0 being lowest quality of life, 100 being highest quality of life.
Time frame: Baseline to 12 months
Population: Intent to Treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental | Incontinence Quality of Life (IQoL) Questionnaire | 28.63 units on a scale | Standard Deviation 29.69 |
Secondary
Number of Incontinence Episodes Per Day (Voiding Diary)
Change in Number of Incontinence Episodes Per Day from baseline to 12 months. 0 being the best.
Time frame: Baseline to 12 months
Population: Intent to Treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental | Number of Incontinence Episodes Per Day (Voiding Diary) | -2.76 units on a scale | Standard Deviation 5.06 |
Secondary
Number of Pads Changed Per Day (Voiding Diary)
Change in Number of Pads Changed Per Day from baseline to 12 months. 0 pads changed a day being the best.
Time frame: Baseline to 12 months
Population: Intent to Treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental | Number of Pads Changed Per Day (Voiding Diary) | -1.59 Number of Pads Changed per Day | Standard Deviation 3.63 |
Secondary
Provocative Pad Weight
Change in weight of pads (gm) from baseline to 12 months. 0 gm pad weight being the best.
Time frame: Baseline to 12 months
Population: Intent to Treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental | Provocative Pad Weight | -31.03 gm | Standard Deviation 55.27 |
Secondary
Urinary Distress Inventory (UDI-6)
Change on Urinary Distress Inventory (UDI-6) questionnaire from baseline to 12 months. 0 being not distressed, 100 being very distressed.
Time frame: Baseline to 12 months
Population: Intent to Treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental | Urinary Distress Inventory (UDI-6) | -22.66 units on a scale | Standard Deviation 24.47 |