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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Lower Urinary Tract Symptoms
Signs and Symptoms
Urination Disorders
Urologic Diseases
Urological Manifestations

ClinicalTrials.gov processed this record on October 21, 2014