Stress Urinary Incontinence
Conditions
Keywords
Stress urinary Incontinence, Transobturator sling, TOT
Brief summary
This is a prospective, observational, multicenter study of women with surgically-correctable stress urinary incontinence who undergo a TOT-sling operative procedure.
Detailed description
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.
Interventions
None listed
Sponsors
Cantonal Hospital, Frauenfeld
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. Patient has objective demonstrable signs of stress urinary incontinence (SUI), including patients with intrinsic sphincter deficiency (ISD). Objective testing includes: standing stress test, urodynamics evaluation, or pad test. 2. Patient is age 18 or older. 3. Patient agrees to participate in the study, including completion of all study-related procedures and evaluations, and documents this agreement by signing the Institutional Review Board (IRB)/Ethic commission (EC)-approved informed consent. 4. Patient is able to fill in all questionnaires (on judgement of investigator)
Exclusion criteria
1. Patient has an associated or suspected neurological disease. 2. Patient has an active lesion or present injury to perineum or urethra. 3. Patient has a urethral obstruction. 4. Patient has significant pelvic organ prolapse (Grade III/IV) requiring surgical treatment. 5. Patient currently has an urinary tract infection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cure rate | 6 months postoperative | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Urethral length | Preoperative | Urethral length will be measured by pelvic floor sonography. |
| Linear urethral dorsocaudal movement (LUDM) | Preoperative | Linear urethral dorsocaudal movement (LUDM) will be assessed by pelvic floor sonography. |
| Urethral tape position | 1-3 days and 6 months postoperative | The position of the TOT along the urethra will be determined by pelvic floor sonography and expressed as percentage of urethral length. |
| Distance between tape and longitudinal smooth muscle (LSM) complex | 1-3 days and 6 months postoperative | 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. |
| Urodynamic testing | Preoperative | Urodynamic testing will be performed only for patients undergoing recurrent incontinence surgery. |
Countries
Germany, Switzerland
Outcome results
None listed