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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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18 March 2024 |
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Main ID: |
NCT01753011 |
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Date of registration:
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17/12/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Urethral Length and TOT (Transobturator Tape) Positioning
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Scientific title:
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Prospective, Observational Study: Can Pelvic Floor Ultrasound Help to Optimize TOT (Transobturator Tape) Positioning? |
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Date of first enrolment:
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May 2007 |
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Target sample size:
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123 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT01753011 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Germany
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Switzerland
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Contacts
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Name:
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Volker Viereck, Prof. Dr. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Cantonal Hospital, Frauenfeld |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
99 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Stress Urinary Incontinence
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Primary Outcome(s)
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Cure rate
[Time Frame: 6 months postoperative]
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Secondary Outcome(s)
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Urethral tape position
[Time Frame: 1-3 days and 6 months postoperative]
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Distance between tape and longitudinal smooth muscle (LSM) complex
[Time Frame: 1-3 days and 6 months postoperative]
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Urodynamic testing
[Time Frame: Preoperative]
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Linear urethral dorsocaudal movement (LUDM)
[Time Frame: Preoperative]
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Urethral length
[Time Frame: Preoperative]
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Secondary ID(s)
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TOT 1/2-Rule
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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