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This is a prospective, observational, multicenter study of women with surgically-correctable stress urinary incontinence who undergo a TOT-sling operative procedure.
This is a prospective, observational, multicenter study of women with surgically-correctable stress urinary incontinence who undergo a TOT-sling operative procedure. Data will be collected from preoperative urogynecological testing and medical histories. Outcome data will be collected 1-3 days and 6 months after procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stress Urinary Incontinence | Stress Urinary Incontinence |
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| Measure | Description | Time Frame |
|---|---|---|
| Cure rate | The primary outcome of the TOT procedure will be assessed using a combination of objective and subjective criteria. Patients with a negative stress test, a negative 1-h pad test (less than 2 g) and the degree of subjective suffering improving to over 90% (VAS score of 0-1) at 6 months follow-up evaluation are classified as cured. All other patients are classified as treatment failure even if one aspect shows marked improvement from the preoperative condition. | 6 months postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Urethral length | Urethral length will be measured by pelvic floor sonography. | Preoperative |
| Linear urethral dorsocaudal movement (LUDM) | Linear urethral dorsocaudal movement (LUDM) will be assessed by pelvic floor sonography. |
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Inclusion Criteria:
Exclusion Criteria:
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The study population includes women with surgically-corrected stress urinary incontinence who undergo a TOT operative procedure.
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| Name | Affiliation | Role |
|---|---|---|
| Volker Viereck, Prof. Dr. | Cantonal Hospital, Frauenfeld | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gynecology and Obstetrics, Lutheran Hospital Hagen-Haspe | Hagen | Germany | ||||
| Blasenzentrum, Cantonal Hospital |
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| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Preoperative |
| Urethral tape position | The position of the TOT along the urethra will be determined by pelvic floor sonography and expressed as percentage of urethral length. | 1-3 days and 6 months postoperative |
| Distance between tape and longitudinal smooth muscle (LSM) complex | To characterize the location of the TOT, the shortest distance between the tape and the longitudinal smooth muscle (LSM) complex of the urethra will be measured by pelvic floor sonography. | 1-3 days and 6 months postoperative |
| Urodynamic testing | Urodynamic testing will be performed only for patients undergoing recurrent incontinence surgery. | Preoperative |
| Frauenfeld |
| Thurgau |
| Switzerland |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| 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 |