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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
Sponsor:
Information provided by (Responsible Party):
Elizabeth Mueller, 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.

Condition or disease Intervention/treatment Phase
Stress Urinary Incontinence Urinary Incontinence Other: Foley Catheter Not Applicable

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  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Precise Transvaginal Tape Placement Trial
Study Start Date : March 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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. 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.

  3. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
United States, Illinois
Loyola University Health System
Maywood, Illinois, United States, 60153
Sponsors and Collaborators
Loyola University
Investigators
Principal Investigator: Elizabeth R Mueller, M.D. Loyola University

Publications:

Responsible Party: Elizabeth Mueller, M.D., Associate Professor, Loyola University
ClinicalTrials.gov Identifier: NCT02101489     History of Changes
Other Study ID Numbers: 206041
First Posted: April 2, 2014    Key Record Dates
Last Update Posted: March 1, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Elizabeth Mueller, Loyola University:
TVT
Stress urinary incontinence

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders