Precise Transvaginal Tape Placement Trial
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|ClinicalTrials.gov Identifier: NCT02101489|
Recruitment Status : Completed
First Posted : April 2, 2014
Last Update Posted : March 1, 2017
|Condition or disease||Intervention/treatment||Phase|
|Stress Urinary Incontinence Urinary Incontinence||Other: Foley Catheter||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||56 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Precise Transvaginal Tape Placement Trial|
|Study Start Date :||March 2014|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||November 2016|
Active Comparator: Intraop Foley catheter measurement
20 women will have intraoperative Foley catheter measurement of the urethral length
Other: Foley Catheter
20 with intraoperative Foley catheter measurement of the urethral length and 20 without
No Intervention: Without intraop Foley cath measurement
20 women without intraoperative Foley catheter measurement of the urethral length
- If using a Foley catheter is a reliable way to measure the urethral length before placing the tension free vaginal tape in the mid-urethra. [ Time Frame: 2 weeks ]measurement of the urethral length by marking the Foley catheter at the urethral meatus when it is placed at the start of the surgical case. When the catheter is removed, the length from the end of the Foley balloon to the marking at the urethra will be measured as urethral length, the mid urethral point will then be determined by dividing the urethral length be two where the incision of sling placement will be made.
- Comparing urethral length measurement with the Foley catheter and 3D ultrasound. [ Time Frame: 2 weeks ]All women in the study will have an ultrasound at the end of their surgical procedure and a follow-up ultrasound at 2 weeks post operatively to assess for sling migration.
- Location change of mid-urethral slings from the time of surgery to 2 weeks after surgery. [ Time Frame: 2 weeks ]We will then compare the mid-point location of the midurethral sling between the group that received an intra-op Foley catheter measurement to the group that didn't receive the Foley catheter.
- Stratify the data based on patient race, BMI, prolapse and age [ Time Frame: 6 weeks ]Stratify the data based on patient race, BMI, prolapse and age
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02101489
|United States, Illinois|
|Loyola University Health System|
|Maywood, Illinois, United States, 60153|
|Principal Investigator:||Elizabeth R Mueller, M.D.||Loyola University|