Urethral Length and TOT (Transobturator Tape) Positioning

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Volker Viereck, Cantonal Hospital, Frauenfeld
ClinicalTrials.gov Identifier:
NCT01753011
First received: December 17, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  Purpose

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


Condition
Stress Urinary Incontinence

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective, Observational Study: Can Pelvic Floor Ultrasound Help to Optimize TOT (Transobturator Tape) Positioning?

Resource links provided by NLM:


Further study details as provided by Cantonal Hospital, Frauenfeld:

Primary Outcome Measures:
  • Cure rate [ Time Frame: 6 months postoperative ] [ Designated as safety issue: No ]
    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 [ Time Frame: Preoperative ] [ Designated as safety issue: No ]
    Urethral length will be measured by pelvic floor sonography.

  • Linear urethral dorsocaudal movement (LUDM) [ Time Frame: Preoperative ] [ Designated as safety issue: No ]
    Linear urethral dorsocaudal movement (LUDM) will be assessed by pelvic floor sonography.

  • Urethral tape position [ Time Frame: 1-3 days and 6 months postoperative ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1-3 days and 6 months postoperative ] [ Designated as safety issue: No ]
    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 [ Time Frame: Preoperative ] [ Designated as safety issue: No ]
    Urodynamic testing will be performed only for patients undergoing recurrent incontinence surgery.


Enrollment: 123
Study Start Date: May 2007
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Stress Urinary Incontinence
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01753011

Locations
Germany
Department of Gynecology and Obstetrics, Lutheran Hospital Hagen-Haspe
Hagen, Germany
Switzerland
Blasenzentrum, Cantonal Hospital
Frauenfeld, Thurgau, Switzerland
Sponsors and Collaborators
Cantonal Hospital, Frauenfeld
Investigators
Principal Investigator: Volker Viereck, Prof. Dr. Cantonal Hospital, Frauenfeld
  More Information

No publications provided

Responsible Party: Prof. Dr. Volker Viereck, Cantonal Hospital, Frauenfeld
ClinicalTrials.gov Identifier: NCT01753011     History of Changes
Other Study ID Numbers: TOT 1/2-Rule
Study First Received: December 17, 2012
Last Updated: December 17, 2012
Health Authority: Switzerland: Swissmedic

Keywords provided by Cantonal Hospital, Frauenfeld:
Stress urinary Incontinence
Transobturator sling
TOT

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on April 20, 2014