Urethral Length and TOT (Transobturator Tape) Positioning

Cantonal Hospital, Frauenfeld

Status: Completed

Conditions: Stress Urinary Incontinence

Study type: Observational

Funder types: Other

Identifiers

NCT01753011

TOT 1/2-Rule

Details and patient eligibility

About

This is a prospective, observational, multicenter study of women with surgically-correctable stress urinary incontinence who undergo a TOT-sling operative procedure.

Full 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.

Enrollment: 123 patients

Sex: Female

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

123 participants in 1 patient group

Stress Urinary Incontinence

Description:

Stress Urinary Incontinence