Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ethicon, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a pilot study to assess the feasibility and success of performing the TVT-Secur in the office setting. Endpoints would be success, complications, and patient and physician acceptance of the procedure. Success would be assessed by validated questionnaires.
This is a prospective single arm study of 50 patients who will have the TVT-Secur procedure done in the office under local anesthesia. They will be followed for a period of 3 years.
The study will include 50 patients who would meet the inclusion/exclusion criteria and who sign the informed consent. Subjects are diagnosed with Stress urinary incontinence resulting from urethral hypermobility with no prior urinary incontinence surgery. Subjects are women who no longer intend to bear children and who do not require any other concomitant surgery.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gynecare TVT-SECUR system | Experimental | All patients enrolled into the study will receive the TVT-SECUR system to treat stress urinary incontinence |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gynecare TVT-SECUR system | Device | All patients in the study will receive the Gynecare TVT-SECUR to treat stress urinary incontinence |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Success Based on Patient Report on Validated Questionnaire | Negative response to question #3 on the Urogenital Distress Inventory-6 (UDI-6) questionnaire. Question #3 states, "Do you currently experience urine leakage related to physical activity, coughing or sneezing." If a subject answers "No", this is considered success. If a subject answers "Yes", this is considered failure of treatment. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction | Positive response to a satisfaction question | 12 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Salil S Khandwala, MD | Michigan Institute of Women's Health PC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Urogynecology of Michigan PC | Dearborn | Michigan | 48124 | United States |
Not provided
Recruitment period: October 2008-May 2009 at medical practice
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Gynecare TVT-SECUR System | All patients enrolled into the study will receive the TVT-SECUR system to treat stress urinary incontinence Gynecare TVT-SECUR system: All patients in the study will receive the Gynecare TVT-SECUR to treat stress urinary incontinence |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Gynecare TVT-SECUR System | All patients enrolled into the study will receive the TVT-SECUR system to treat stress urinary incontinence Gynecare TVT-SECUR system: All patients in the study will receive the Gynecare TVT-SECUR to treat stress urinary incontinence |
| 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 | Treatment Success Based on Patient Report on Validated Questionnaire | Negative response to question #3 on the Urogenital Distress Inventory-6 (UDI-6) questionnaire. Question #3 states, "Do you currently experience urine leakage related to physical activity, coughing or sneezing." If a subject answers "No", this is considered success. If a subject answers "Yes", this is considered failure of treatment. | 46 subjects were analyzed at the 24 month period out of the total 50 subjects enrolled in the study. | Posted | Count of Participants | Participants | 24 months |
|
Adverse event data collected for 36 months following subject TVT-Secur procedure date.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Gynecare TVT-SECUR System | All patients enrolled into the study will receive the TVT-SECUR system to treat stress urinary incontinence Gynecare TVT-SECUR system: All patients in the study will receive the Gynecare TVT-SECUR to treat stress urinary incontinence |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mesh Exposure | Product Issues | Systematic Assessment | 1 cm x 1 cm mesh exposure noted during follow-up examination. This was managed expectantly by the principal investigator. |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Salil Khandwala/Medical Director | Michigan Institute of Women's Health | 313-982-0200 |
Not provided
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
| ID | Term |
|---|---|
| D053825 | Suburethral Slings |
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Participants |
|
| Age, Continuous | Median | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Patient Satisfaction | Positive response to a satisfaction question | 49 subjects were analyzed at the 12 month period out of the total 50 subjects enrolled in the study. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| 1 |
| 50 |
|
Not provided
Not provided
Not provided
| 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 |