Urethral Length and TOT (Transobturator Tape) Positioning

March 6, 2024 updated by: Prof. Dr. Volker Viereck, Cantonal Hospital, Frauenfeld

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

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

123

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Sampling Method

Probability Sample

Study Population

The study population includes women with surgically-corrected stress urinary incontinence who undergo a TOT operative procedure.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Stress Urinary Incontinence

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cure rate Time Frame: 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.	6 months postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urethral length Time Frame: Preoperative	Urethral length will be measured by pelvic floor sonography.	Preoperative
Linear urethral dorsocaudal movement (LUDM) Time Frame: Preoperative	Linear urethral dorsocaudal movement (LUDM) will be assessed by pelvic floor sonography.	Preoperative
Urethral tape position Time Frame: 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.	1-3 days and 6 months postoperative
Distance between tape and longitudinal smooth muscle (LSM) complex Time Frame: 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.	1-3 days and 6 months postoperative
Urodynamic testing Time Frame: Preoperative	Urodynamic testing will be performed only for patients undergoing recurrent incontinence surgery.	Preoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cantonal Hospital, Frauenfeld

Investigators

Principal Investigator: Volker Viereck, Prof. Dr., Cantonal Hospital, Frauenfeld

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

December 17, 2012

First Submitted That Met QC Criteria