Precise Transvaginal Tape Placement Trial

Not Applicable

Completed

• Conditions: Stress Urinary Incontinence; Urinary Incontinence
• Interventions: Other: Foley Catheter

• Registration Number: NCT02101489
• Lead Sponsor: Loyola University

Brief Summary

This purpose of this study is to study is to see if intra-operative urethral length measurement with the Foley catheter will improve the placement of a synthetic sling in the mid-urethra.

Detailed Description

This study will assess the effect of intraoperative measurement of the urethral length with the Foley catheter in optimization of sling placement in the mid female urethra. Of note, the Foley catheter is well-tolerated, placed routinely during surgery to drain the bladder and has no complications associated with it. Women who have chosen to undergo trans-vaginal tape sling (TVT) for stress urinary incontinence will be asked to enroll in this randomized trial by the study team during their clinic visit. Randomization will be performed by the FPMRS study nurse coordinator after a woman has given her informed consent and meets the study criteria. Twenty women will be randomized to undergo 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 and twenty women will have our usual pre-operative assessment (which does not include intraoperative measurement of the urethral length with the Foley catheter) for the treatment of symptomatic stress urinary incontinence All women participating in the study will receive an intra-operative 3-D trans-vaginal ultrasound (BK Flex Focus ultrasound with the 8838 transvaginal probe). The image will be stored and reviewed for; urethral length, urethral sphincter complex length and width. 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. Of note, transvaginal ultrasound is well-tolerated and has no complications associated with it. All ultrasound measurements will be done by a four qualified surgeons, Dr. Elizabeth Mueller Dr. Ahmed Akl, Dr. Tanaka Dune, and Dr. Susanne Taege who have been trained on ultrasound measurements. In addition, women will complete questionnaires assessing their pelvic floor symptoms pre-operatively and at 2 week following surgery. Instruments used will be the Pelvic Floor Disorders Inventory (PFDI), Medical Epidemiologic and Social Aging (MESA) and the Patient Global Impression of Improvement (PGII) \[11, 12\].

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-19
• Study First Submitted QC: 2014-03-27
• Study First Posted: 2014-04-02
• Primary Completion: 2015-12
• Study Completion: 2016-11
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-28
• Last Update Posted: 2017-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 56

Inclusion Criteria

• Candidates for TVT
• >=18 years of age to participate

Exclusion Criteria

• Inability to give informed consent
• Previous SUI(stress urinary incontinence) treatment including TVT, Burch or urethral bulking agents
• Previous bladder, urethral malignancies or vaginal/pelvic radiation treatment.
• Pregnant women cannot participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intraop Foley catheter measurement	Foley Catheter	20 women will have intraoperative Foley catheter measurement of the urethral length

Primary Outcome Measures

Name	Time	Method
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.	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.

Secondary Outcome Measures

Name	Time	Method
Comparing urethral length measurement with the Foley catheter and 3D ultrasound.	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.	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	6 weeks	Stratify the data based on patient race, BMI, prolapse and age

Trial Locations

Locations (1)

Loyola University Health System; 🇺🇸 Maywood, Illinois, United States