Urethral Length and TOT (Transobturator Tape) Positioning
This study has been completed.
Sponsor:
Cantonal Hospital, Frauenfeld
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
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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:
- 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.
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 May 23, 2013