Urethral Length and TOT (Transobturator Tape) Positioning

Stress Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01753011
• Other study ID #: TOT 1/2-Rule
• Status: Completed
• Start date: May 2007
• Est. completion date: May 2009

Study information

• Verified date: March 2024
• Source: Cantonal Hospital, Frauenfeld
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Locations

Country	Name	City	State
Germany	Department of Gynecology and Obstetrics, Lutheran Hospital Hagen-Haspe	Hagen
Switzerland	Blasenzentrum, Cantonal Hospital	Frauenfeld	Thurgau

Sponsors (1)

Lead Sponsor	Collaborator
Cantonal Hospital, Frauenfeld

Countries where clinical trial is conducted

Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months postoperative
Secondary	Urethral length	Urethral length will be measured by pelvic floor sonography.	Preoperative
Secondary	Linear urethral dorsocaudal movement (LUDM)	Linear urethral dorsocaudal movement (LUDM) will be assessed by pelvic floor sonography.	Preoperative
Secondary	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.	1-3 days and 6 months postoperative
Secondary	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.	1-3 days and 6 months postoperative
Secondary	Urodynamic testing	Urodynamic testing will be performed only for patients undergoing recurrent incontinence surgery.	Preoperative