Urethral Length and TOT (Transobturator Tape) Positioning

Completed

• Conditions: Stress Urinary Incontinence

• Registration Number: NCT01753011
• Lead Sponsor: Cantonal Hospital, Frauenfeld

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.

Study Timeline

• Study Start: 2007-05
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Study First Submitted: 2012-12-17
• Study First Submitted QC: 2012-12-17
• Study First Posted: 2012-12-19
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-06
• Last Update Posted: 2024-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 123

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
Urodynamic testing	Preoperative	Urodynamic testing will be performed only for patients undergoing recurrent incontinence surgery.
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.

Trial Locations

Locations (2)

Department of Gynecology and Obstetrics, Lutheran Hospital Hagen-Haspe; 🇩🇪 Hagen, Germany

Blasenzentrum, Cantonal Hospital; 🇨🇭 Frauenfeld, Thurgau, Switzerland