An interventional study of TOT 8/4 and TOT 6/3 in Urinary Incontinence, sponsored by Klinikum der Universität Köln. Status unknown at 1 site in Germany. Open to female participants. Per ClinicalTrials.gov, last updated 2015-11-05.
Sponsored by Klinikum der Universität Köln · Not applicable and Interventional
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.
Retrospective studies demonstrated that the distance between urethra and suburethral sling can vary considerably between 1 mm and 10 mm. In order to standardize the placement of the suburethral sling we choose two different distances between urethra and sling.
Transobturator tape (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 sling 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.
According to the used Hegar dilator sounds two different techniques are used:
TOT 8/4 or TOT 6/3.
1,375 studies on the registry are indexed under Urinary Incontinence; 224 are open to participants now.
This study's planned enrollment of 120 is above the median of 66 across 1,021 interventional studies indexed under Urinary Incontinence.
Browse Urinary Incontinence studies →Klinikum der Universität Köln is the lead sponsor of 7 studies on the registry; none are open to participants now.
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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.
Device: TOT 8/4
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.
Device: TOT 6/3
placement of transobturator sling according to the TOT 8/4 technique
placement of transobturator sling according to the TOT 6/3 technique
Distance between urethra and transobturator sling
transvaginal ultrasound measurements
Time frame: 2 weeks
Distance between urethra and transobturator sling
transvaginal ultrasound measurements
Time frame: 16 weeks
This study is status unknown, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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Klinikum der Universität Köln