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.
Study Type
OBSERVATIONAL
Enrollment
123
Department of Gynecology and Obstetrics, Lutheran Hospital Hagen-Haspe
Hagen, Germany
Blasenzentrum, Cantonal Hospital
Frauenfeld, Thurgau, Switzerland
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.
Time frame: 6 months postoperative
Urethral length
Urethral length will be measured by pelvic floor sonography.
Time frame: Preoperative
Linear urethral dorsocaudal movement (LUDM)
Linear urethral dorsocaudal movement (LUDM) will be assessed by pelvic floor sonography.
Time frame: 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.
Time frame: 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.
Time frame: 1-3 days and 6 months postoperative
Urodynamic testing
Urodynamic testing will be performed only for patients undergoing recurrent incontinence surgery.
Time frame: Preoperative
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