Precise Transvaginal Tape Placement Trial

February 28, 2017 updated by: Elizabeth Mueller, Loyola University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Loyola University Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 weeks
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.
2 weeks
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
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loyola University

Investigators

  • Principal Investigator: Elizabeth R Mueller, M.D., Loyola University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (ACTUAL)

December 1, 2015

Study Completion (ACTUAL)

November 1, 2016

Study Registration Dates

First Submitted

March 19, 2014

First Submitted That Met QC Criteria

March 27, 2014

First Posted (ESTIMATE)

April 2, 2014

Study Record Updates

Last Update Posted (ACTUAL)

March 1, 2017

Last Update Submitted That Met QC Criteria

February 28, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 206041

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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