Stress Urinary Incontinence, Urinary Incontinence
Conditions
Keywords
urinary incontinence, stress urinary incontinence, mid-urethral slings, Tension-free vaginal taping, TVT
Brief summary
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.
Detailed description
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.
Interventions
DEVICEGynecare TVT-SECUR system
All patients in the study will receive the Gynecare TVT-SECUR to treat stress urinary incontinence
Sponsors
Ethicon, Inc.
Michigan Institution of Women's Health PC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* Stress urinary incontinence with hypermobility of the UV junction * ASA I or II * Age 21-89
Exclusion criteria
* Prior anti-incontinence surgery * Not completed childbearing * ASA III or higher * Need concomitant surgery * Poor compliance for office based approach
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Success Based on Patient Report on Validated Questionnaire | 24 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction | 12 months | Positive response to a satisfaction question |
Countries
United States
Participant flow
Recruitment details
Recruitment period: October 2008-May 2009 at medical practice
Participants by arm
| Arm | Count |
|---|---|
| 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 | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | Gynecare TVT-SECUR System |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 49 Participants |
| Age, Continuous | 46.7 years STANDARD_DEVIATION 8.8 |
| Race/Ethnicity, Customized Hispanic or Latino | 3 Participants |
| Race/Ethnicity, Customized White | 47 Participants |
| Region of Enrollment United States | 50 participants |
| Sex: Female, Male Female | 50 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 50 |
| other Total, other adverse events | 1 / 50 |
| serious Total, serious adverse events | 0 / 50 |
Outcome results
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.
Time frame: 24 months
Population: 46 subjects were analyzed at the 24 month period out of the total 50 subjects enrolled in the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Gynecare TVT-SECUR System | Treatment Success Based on Patient Report on Validated Questionnaire | 42 Participants |
Secondary
Patient Satisfaction
Positive response to a satisfaction question
Time frame: 12 months
Population: 49 subjects were analyzed at the 12 month period out of the total 50 subjects enrolled in the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Gynecare TVT-SECUR System | Patient Satisfaction | 47 Participants |