Urethral Length and TOT (Transobturator Tape) Positioning

Sponsor

Cantonal Hospital, Frauenfeld (Other)

Overall Status

Completed

CT.gov ID

NCT01753011

Collaborator

(none)

123

Enrollment

Locations

Duration (Months)

61.5

Patients Per Site

2.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Stress Urinary Incontinence

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.

Study Design

Study Type:

Observational

Actual Enrollment :

123 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Prospective, Observational Study: Can Pelvic Floor Ultrasound Help to Optimize TOT (Transobturator Tape) Positioning?

Study Start Date :

May 1, 2007

Actual Primary Completion Date :

May 1, 2009

Actual Study Completion Date :

May 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Stress Urinary Incontinence Stress Urinary Incontinence

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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.
Patient is age 18 or older.
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.
Patient is able to fill in all questionnaires (on judgement of investigator)

Exclusion Criteria:

Patient has an associated or suspected neurological disease.
Patient has an active lesion or present injury to perineum or urethra.
Patient has a urethral obstruction.
Patient has significant pelvic organ prolapse (Grade III/IV) requiring surgical treatment.
Patient currently has an urinary tract infection.