Stress Urinary Incontinence
Conditions
Keywords
stress urinary incontinence, sling procedures, tension-free vaginal tape
Brief summary
The purpoe of this study is to compare the safety and efficacy of the tension-free vaginal tape procedure (TVT) to the TVT-SECUR procedure in the treatment of stress urinary incontinence.
Interventions
Retropubic mid-urethral sling
DEVICETVT-SECUR device
Mid-urethral mini-sling
Sponsors
Good Samaritan Hospital, Ohio
Greater Baltimore Medical Center
Medstar Health Research Institute
Duke University
Foundation for Female Health Awareness
Women and Infants Hospital of Rhode Island
Main Line Health
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Urinary incontinence symptoms * Urodynamic stress incontinence confirmed with multichannel urodynamic testing * Age of at least 21 years * Desires surgical correction of stress urinary incontinence
Exclusion criteria
* Post-void residual volume \>100cc * Detrusor overactivity on preoperative multichannel urodynamic testing * History of previous synthetic, biologic or fascial sub-urethral sling * Desires future childbearing * History of bleeding diathesis or current anti-coagulation therapy * Current genitourinary fistula or urethral diverticulum * Reversible cause of incontinence (i.e. drug effect) * Contraindication to surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Cure of Urinary Incontinence at 12 Months After Surgery | 12 months | Composite outcome defined as absence of urinary incontinence as indicated by the Incontinence Severity Index score of 0 and the absence of any additional surgical or nonsurgical treatment of stress urinary incontinence (SUI) after the index surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post Operative Complications at 6 Week or Less | 6 week | — |
| Long Term Complications > 6 Weeks | 6 weeks-12 months | — |
| Patient Global Impression Improvement | 12 months | — |
| Incontinence Severity Index Score | 12 months | The incontinence severity index comprises the following two questions. How often do you experience urine leakage (0=never, 1=less than once a month, 2=one or several times a month, 3=one or several times a week, 4=every day and/or night)? How much urine do you lose each time (1=drops or little, 2=more)? The total score is the score for the first question multiplied by the score for the second question (0=dry, 1-2=slight, 3-4=moderate, 6-8=severe). |
Countries
United States
Participant flow
Pre-assignment details
A total of 281 patients were enrolled. Of these, 18 patients withdrew prior to randomization (including for the following reasons- cancelled surgery (6), did not meet inclusion criteria (4), declined further participation (8)).
Participants by arm
| Arm | Count |
|---|---|
| TVT Procedure Tension-free vaginal tape procedure (TVT)
tension-free vaginal tape: Retropubic mid-urethral sling | 127 |
| TVT-SECUR Mini Sling Procedure TVT-SECUR device
TVT-SECUR device: Mid-urethral mini-sling | 136 |
| Total | 263 |
Baseline characteristics
| Characteristic | TVT Procedure | TVT-SECUR Mini Sling Procedure | Total |
|---|---|---|---|
| Age, Continuous | 54.6 years STANDARD_DEVIATION 11.3 | 54.6 years STANDARD_DEVIATION 10.5 | 54.6 years STANDARD_DEVIATION 11 |
| Body mass index | 30.0 kg/m^2 STANDARD_DEVIATION 5.7 | 29.6 kg/m^2 STANDARD_DEVIATION 6.4 | 29.8 kg/m^2 STANDARD_DEVIATION 6 |
| Race/Ethnicity, Customized African American | 4 Participants | 12 Participants | 16 Participants |
| Race/Ethnicity, Customized Other | 3 Participants | 6 Participants | 9 Participants |
| Race/Ethnicity, Customized White | 120 Participants | 118 Participants | 238 Participants |
| Region of Enrollment United States | 127 participants | 136 participants | 263 participants |
| Sex/Gender, Customized Female | 127 participants | 136 participants | 263 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 136 | 8 / 127 |
| serious Total, serious adverse events | 0 / 136 | 0 / 127 |
Outcome results
Primary
Subjective Cure of Urinary Incontinence at 12 Months After Surgery
Composite outcome defined as absence of urinary incontinence as indicated by the Incontinence Severity Index score of 0 and the absence of any additional surgical or nonsurgical treatment of stress urinary incontinence (SUI) after the index surgery.
Time frame: 12 months
Population: Analysis based on per protocol enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TVT Procedure | Subjective Cure of Urinary Incontinence at 12 Months After Surgery | 77 Participants |
| TVT-SECUR Mini Sling Procedure | Subjective Cure of Urinary Incontinence at 12 Months After Surgery | 72 Participants |
p-value: 0.43Regression, Logistic
Secondary
Incontinence Severity Index Score
The incontinence severity index comprises the following two questions. How often do you experience urine leakage (0=never, 1=less than once a month, 2=one or several times a month, 3=one or several times a week, 4=every day and/or night)? How much urine do you lose each time (1=drops or little, 2=more)? The total score is the score for the first question multiplied by the score for the second question (0=dry, 1-2=slight, 3-4=moderate, 6-8=severe).
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TVT Procedure | Incontinence Severity Index Score | 2.2 units on a scale | Standard Deviation 2.7 |
| TVT-SECUR Mini Sling Procedure | Incontinence Severity Index Score | 1.5 units on a scale | Standard Deviation 1.9 |
p-value: 0.015t-test, 2 sided
Secondary
Long Term Complications > 6 Weeks
Time frame: 6 weeks-12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TVT Procedure | Long Term Complications > 6 Weeks | Infection requiring antibiotics | 0 participants |
| TVT Procedure | Long Term Complications > 6 Weeks | Cardiac or myocardial infection | 0 participants |
| TVT Procedure | Long Term Complications > 6 Weeks | Neurologic | 0 participants |
| TVT Procedure | Long Term Complications > 6 Weeks | Pulmonary | 0 participants |
| TVT Procedure | Long Term Complications > 6 Weeks | Ileu or small bowel obstruction | 0 participants |
| TVT Procedure | Long Term Complications > 6 Weeks | Mesh exposure | 0 participants |
| TVT Procedure | Long Term Complications > 6 Weeks | Leg pain or difficulty ambulatig | 1 participants |
| TVT Procedure | Long Term Complications > 6 Weeks | Fistula | 0 participants |
| TVT-SECUR Mini Sling Procedure | Long Term Complications > 6 Weeks | Fistula | 0 participants |
| TVT-SECUR Mini Sling Procedure | Long Term Complications > 6 Weeks | Infection requiring antibiotics | 0 participants |
| TVT-SECUR Mini Sling Procedure | Long Term Complications > 6 Weeks | Ileu or small bowel obstruction | 0 participants |
| TVT-SECUR Mini Sling Procedure | Long Term Complications > 6 Weeks | Cardiac or myocardial infection | 0 participants |
| TVT-SECUR Mini Sling Procedure | Long Term Complications > 6 Weeks | Leg pain or difficulty ambulatig | 0 participants |
| TVT-SECUR Mini Sling Procedure | Long Term Complications > 6 Weeks | Neurologic | 1 participants |
| TVT-SECUR Mini Sling Procedure | Long Term Complications > 6 Weeks | Mesh exposure | 1 participants |
| TVT-SECUR Mini Sling Procedure | Long Term Complications > 6 Weeks | Pulmonary | 0 participants |
Secondary
Patient Global Impression Improvement
Time frame: 12 months
Population: Please note that no all participants conducted the global improvement scale survey due to loss to follow up.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TVT Procedure | Patient Global Impression Improvement | No different | 3 Participants |
| TVT Procedure | Patient Global Impression Improvement | Very much better | 63 Participants |
| TVT Procedure | Patient Global Impression Improvement | Somewhat worse | 3 Participants |
| TVT Procedure | Patient Global Impression Improvement | Somewhat better | 11 Participants |
| TVT Procedure | Patient Global Impression Improvement | Much worse | 2 Participants |
| TVT Procedure | Patient Global Impression Improvement | Very much worse | 3 Participants |
| TVT Procedure | Patient Global Impression Improvement | Much better | 24 Participants |
| TVT-SECUR Mini Sling Procedure | Patient Global Impression Improvement | Very much worse | 1 Participants |
| TVT-SECUR Mini Sling Procedure | Patient Global Impression Improvement | Very much better | 67 Participants |
| TVT-SECUR Mini Sling Procedure | Patient Global Impression Improvement | Much better | 24 Participants |
| TVT-SECUR Mini Sling Procedure | Patient Global Impression Improvement | Somewhat better | 9 Participants |
| TVT-SECUR Mini Sling Procedure | Patient Global Impression Improvement | No different | 1 Participants |
| TVT-SECUR Mini Sling Procedure | Patient Global Impression Improvement | Somewhat worse | 3 Participants |
| TVT-SECUR Mini Sling Procedure | Patient Global Impression Improvement | Much worse | 0 Participants |
p-value: 0.64t-test, 2 sided
Secondary
Post Operative Complications at 6 Week or Less
Time frame: 6 week
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TVT Procedure | Post Operative Complications at 6 Week or Less | Cardiac or MI | 0 participants |
| TVT Procedure | Post Operative Complications at 6 Week or Less | Blood transfusion | 1 participants |
| TVT Procedure | Post Operative Complications at 6 Week or Less | Pulmonary | 0 participants |
| TVT Procedure | Post Operative Complications at 6 Week or Less | Venous thromboembolism | 1 participants |
| TVT Procedure | Post Operative Complications at 6 Week or Less | Urinary tract infection | 9 participants |
| TVT Procedure | Post Operative Complications at 6 Week or Less | Return to operating room | 0 participants |
| TVT Procedure | Post Operative Complications at 6 Week or Less | Ileus or small bowel obstruction | 0 participants |
| TVT Procedure | Post Operative Complications at 6 Week or Less | Hospital readmissions | 2 participants |
| TVT Procedure | Post Operative Complications at 6 Week or Less | Neurologic | 0 participants |
| TVT Procedure | Post Operative Complications at 6 Week or Less | Emergency room evaluations | 6 participants |
| TVT Procedure | Post Operative Complications at 6 Week or Less | Pelvic abscess | 0 participants |
| TVT Procedure | Post Operative Complications at 6 Week or Less | Unplanned clinic visits | 24 participants |
| TVT Procedure | Post Operative Complications at 6 Week or Less | Post opInfection requiring antibiotics | 5 participants |
| TVT-SECUR Mini Sling Procedure | Post Operative Complications at 6 Week or Less | Unplanned clinic visits | 20 participants |
| TVT-SECUR Mini Sling Procedure | Post Operative Complications at 6 Week or Less | Post opInfection requiring antibiotics | 6 participants |
| TVT-SECUR Mini Sling Procedure | Post Operative Complications at 6 Week or Less | Urinary tract infection | 9 participants |
| TVT-SECUR Mini Sling Procedure | Post Operative Complications at 6 Week or Less | Cardiac or MI | 0 participants |
| TVT-SECUR Mini Sling Procedure | Post Operative Complications at 6 Week or Less | Neurologic | 0 participants |
| TVT-SECUR Mini Sling Procedure | Post Operative Complications at 6 Week or Less | Pulmonary | 1 participants |
| TVT-SECUR Mini Sling Procedure | Post Operative Complications at 6 Week or Less | Ileus or small bowel obstruction | 0 participants |
| TVT-SECUR Mini Sling Procedure | Post Operative Complications at 6 Week or Less | Pelvic abscess | 0 participants |
| TVT-SECUR Mini Sling Procedure | Post Operative Complications at 6 Week or Less | Blood transfusion | 0 participants |
| TVT-SECUR Mini Sling Procedure | Post Operative Complications at 6 Week or Less | Venous thromboembolism | 0 participants |
| TVT-SECUR Mini Sling Procedure | Post Operative Complications at 6 Week or Less | Return to operating room | 1 participants |
| TVT-SECUR Mini Sling Procedure | Post Operative Complications at 6 Week or Less | Hospital readmissions | 2 participants |
| TVT-SECUR Mini Sling Procedure | Post Operative Complications at 6 Week or Less | Emergency room evaluations | 5 participants |