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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Open Label Study, ACT (Adjustable Continence Therapy) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACT (Adjustable Continence Therapy) | Device | surgically implanted device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 12 months |
| Incontinence Impact Questionnaire (IIQ-7) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tim Cook | Uromedica, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente | Los Angeles | California | 90027 | United States | ||
| Emory University School of Medicine |
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | ACT Adjustable Continence Therapy for Women | Open Label Study, patients implanted with ACT device for treatment of Stress Urinary Incontinence |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental | Open Label Study |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | 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. | Intent to Treat | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline to 12 months |
|
Entire Study December 2001 to November 2010 at Study Closure
All adverse events were collected. Overall, although there were a large number of adverse events on the study (883) the majority were unrelated to the device (75%) or the procedure (82%) and 75% resolved with no residual effects. Of the 883 events, 270 of those events (31%) were considered device and/or procedure related.
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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 | ACT Adjustable Continence Therapy for Women | Open Label Study, Patients implanted with ACT device |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| port erosion | Surgical and medical procedures | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain/Discomfort | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Timothy Plouffe | Uromedica | 763-999-7048 | tplouffe@uromedica-inc.com |
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| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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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. |
| Baseline to 12 months |
| 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. | Baseline to 12 months |
| 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. | Baseline to 12 months |
| 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. | Baseline to 12 months |
| Provocative Pad Weight | Change in weight of pads (gm) from baseline to 12 months. 0 gm pad weight being the best. | Baseline to 12 months |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Lahey Clinic | Burlington | Massachusetts | 01805 | United States |
| Metro Urology | Plymouth | Minnesota | 55441 | United States |
| Kansas City Urology Care | Kansas City | Missouri | 64123 | United States |
| Can-Med Clinical Research Inc. | Victoria | British Columbia | V8T5GI | Canada |
| CHUS-Fleurimont | Fleurimont | Quebec | J1H5N4 | Canada |
| Missed Followup |
|
| Lost to Follow-up |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| 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. | Intent to Treat | Posted | Mean | Standard Deviation | units on a scale | Baseline to 12 months |
|
|
|
| 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. | Intent to Treat | Posted | Mean | Standard Deviation | units on a scale | Baseline to 12 months |
|
|
|
| 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. | Intent to Treat | Posted | Mean | Standard Deviation | units on a scale | Baseline to 12 months |
|
|
|
| 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. | Intent to Treat | Posted | Mean | Standard Deviation | units on a scale | Baseline to 12 months |
|
|
|
| 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. | Intent to Treat | Posted | Mean | Standard Deviation | Number of Pads Changed per Day | Baseline to 12 months |
|
|
|
| Secondary | Provocative Pad Weight | Change in weight of pads (gm) from baseline to 12 months. 0 gm pad weight being the best. | Intent to Treat | Posted | Mean | Standard Deviation | gm | Baseline to 12 months |
|
|
|
| 0 |
| 163 |
| 2 |
| 163 |
| 155 |
| 163 |
| Other (non-pelvic) | Cardiac disorders | Systematic Assessment |
|
| Balloon Migration | General disorders | Systematic Assessment | Balloon device moves from implantation site |
|
| Balloon Erosion | General disorders | Systematic Assessment | Balloon Erodes into Vagina, Urethra, or Bladder |
|
| Port Migration | General disorders | Systematic Assessment | Port moves from implantation site |
|
| Port Erosion | General disorders | Systematic Assessment | Port erodes out of implantation site |
|
| Perforation | General disorders | Systematic Assessment | Implantation tools perforate the vagina, urethra, or bladder during implantation procedure |
|
| Worsening Incontinence | Renal and urinary disorders | Systematic Assessment | Patient has worsening incontinence symptoms |
|
| Device Failure | Product Issues | Systematic Assessment | ACT device failure |
|
| Procedure Failure | General disorders | Systematic Assessment | Procedure is not able to be completed |
|
| Infected Device | Infections and infestations | Systematic Assessment | Infection of ACT Device |
|
| Other (Pelvic) | General disorders | Systematic Assessment |
|
| Other (non-Pelvic) | General disorders | Systematic Assessment |
|
| UTI | Renal and urinary disorders | Systematic Assessment | Urinary Tract Infection |
|
| Yeast Infection | Renal and urinary disorders | Systematic Assessment |
|
| Urinary Retention | Renal and urinary disorders | Systematic Assessment |
|
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |