URGE-III
Comparison of the Distance Between the Transobturator Tape (TOT) and the Urethra According to Two Different Placement Techniques of the Tape (TOT 8/4 vs TOT 6/3)
Sponsor study identifier
interventional
120
1 country
1
Study Start
January 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Transobturator tapes (TOT) are placed according to the surgical technique described by Delorme et al. in patients with a previous cervico-sacropexy (CESA) or vagino-sacropexy (VASA). Before final Fixation of the tapes and suturing the vaginal skin a Hegar dilator sound with either 8 mm or 6 mm diameter is placed in the urethra and a second Hegar dilator sound with either 4 mm or 3 mm diameter is placed between the tape and the urethra. After suturing the vaginal skin the Hegar sounds are removed.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2015
Date type not reportedThis date has not been verified as actual or estimated.
November 4, 2015
Actual (reported)November 5, 2015
Actual (reported)December 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Distance between urethra and transobturator sling
transvaginal ultrasound measurements
2 weeks
Distance between urethra and transobturator sling
16 weeks
Transobturator sling (TOT) is placed according to the original description. Instead of a "Metzenbaum Scissor" which should guarantee the distance between the urethra and the sling a Hegar dilator sound of 4 mm diameter is used (Hegar 4). An additional Hegar dilator sound of 8 mm is placed in the urethra before tightening the sling and suturing the vaginal skin.
Transobturator sling (TOT) is placed according to the original description. Instead of a "Metzenbaum Scissor" which should guarantee the distance between the urethra and the sling a Hegar dilator sound of 3 mm diameter is used (Hegar 3). An additional Hegar dilator Sound of 6 mm is placed in the urethra before tightening the sling and suturing the vaginal skin.
placement of transobturator sling according to the TOT 8/4 technique
placement of transobturator sling according to the TOT 6/3 technique
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Department of Obstetrics and Gynecology, University of Cologne
Cologne, North Rhine-Westphalia, 50931, Germany
Wolfram Jager, Professor
Head of the Department of Urogyne
First Submitted
November 4, 2015
First Posted
November 5, 2015
Study Start
January 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2018
Estimated (date passed)Feasibility Study Evaluating the ParaPatch System
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 5, 2015
Record last verified: 2015-11
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