Precise Transvaginal Tape Placement Trial

Urinary Incontinence Clinical Trial

Official title:

Precise Transvaginal Tape Placement Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02101489
• Other study ID #: 206041
• Status: Completed
• Phase: N/A
• First received: March 19, 2014
• Last updated: February 28, 2017
• Start date: March 2014
• Est. completion date: November 2016

Study information

• Verified date: February 2017
• Source: Loyola University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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].

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: November 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Other:
• Foley Catheter
20 with intraoperative Foley catheter measurement of the urethral length and 20 without

Locations

Country	Name	City	State
United States	Loyola University Health System	Maywood	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Loyola University

Country where clinical trial is conducted

United States, 

References & Publications (9)

Aigmueller T, Trutnovsky G, Tamussino K, Kargl J, Wittmann A, Surtov M, Kern P, Frudinger A, Riss P, Bjelic-Radisic V. Ten-year follow-up after the tension-free vaginal tape procedure. Am J Obstet Gynecol. 2011 Nov;205(5):496.e1-5. doi: 10.1016/j.ajog.2011.07.010. — View Citation

Barber MD, Chen Z, Lukacz E, Markland A, Wai C, Brubaker L, Nygaard I, Weidner A, Janz NK, Spino C. Further validation of the short form versions of the Pelvic Floor Distress Inventory (PFDI) and Pelvic Floor Impact Questionnaire (PFIQ). Neurourol Urodyn. 2011 Apr;30(4):541-6. doi: 10.1002/nau.20934. — View Citation

Bjelic-Radisic V, Dorfer M, Greimel E, Frudinger A, Tamussino K, Winter R. Quality of life and continence 1 year after the tension-free vaginal tape operation. Am J Obstet Gynecol. 2006 Dec;195(6):1784-8. — View Citation

Kociszewski J, Rautenberg O, Perucchini D, Eberhard J, Geissbühler V, Hilgers R, Viereck V. Tape functionality: sonographic tape characteristics and outcome after TVT incontinence surgery. Neurourol Urodyn. 2008;27(6):485-90. doi: 10.1002/nau.20556. — View Citation

McGuire EJ, Lytton B. Pubovaginal sling procedure for stress incontinence. 1978. J Urol. 2002 Feb;167(2 Pt 2):1120-3; discussion 1124. — View Citation

Nilsson CG, Palva K, Aarnio R, Morcos E, Falconer C. Seventeen years' follow-up of the tension-free vaginal tape procedure for female stress urinary incontinence. Int Urogynecol J. 2013 Aug;24(8):1265-9. doi: 10.1007/s00192-013-2090-2. — View Citation

Nilsson CG, Palva K, Rezapour M, Falconer C. Eleven years prospective follow-up of the tension-free vaginal tape procedure for treatment of stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Aug;19(8):1043-7. doi: 10.1007/s00192-008-0666-z. — View Citation

Olsson I, Abrahamsson AK, Kroon UB. Long-term efficacy of the tension-free vaginal tape procedure for the treatment of urinary incontinence: a retrospective follow-up 11.5 years post-operatively. Int Urogynecol J. 2010 Jun;21(6):679-83. doi: 10.1007/s00192-009-1083-7. — View Citation

Rahn DD, Marinis SI, Schaffer JI, Corton MM. Anatomical path of the tension-free vaginal tape: reassessing current teachings. Am J Obstet Gynecol. 2006 Dec;195(6):1809-13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	Comparing urethral length measurement with the Foley catheter and 3D ultrasound.	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
Secondary	Location change of mid-urethral slings from the time of surgery to 2 weeks after surgery.	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
Secondary	Stratify the data based on patient race, BMI, prolapse and age	Stratify the data based on patient race, BMI, prolapse and age	6 weeks