Precise Transvaginal Tape Placement Trial

NCT ID: NCT02101489

Last Updated: 2017-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2016-11-30

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].

Conditions

Stress Urinary Incontinence; Urinary Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intraop Foley catheter measurement

20 women will have intraoperative Foley catheter measurement of the urethral length

Group Type: ACTIVE_COMPARATOR

Foley Catheter

Intervention Type: OTHER

20 with intraoperative Foley catheter measurement of the urethral length and 20 without

Without intraop Foley cath measurement

20 women without intraoperative Foley catheter measurement of the urethral length

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Foley Catheter

20 with intraoperative Foley catheter measurement of the urethral length and 20 without

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Loyola University

OTHER

Sponsor Role: lead

Responsible Party

Elizabeth Mueller

M.D., Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elizabeth R Mueller, M.D.

Role: PRINCIPAL_INVESTIGATOR

Loyola University

Locations

Loyola University Health System

Maywood, Illinois, United States

Countries

United States

References

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. Epub 2011 Jul 20.

Reference Type: BACKGROUND

PMID: 21944223 (View on PubMed)

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. Epub 2010 Jan 13.

Reference Type: BACKGROUND

PMID: 20069417 (View on PubMed)

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. Epub 2008 Jun 6.

Reference Type: BACKGROUND

PMID: 18535753 (View on PubMed)

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. Epub 2013 Apr 6.

Reference Type: BACKGROUND

PMID: 23563892 (View on PubMed)

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. doi: 10.1016/j.ajog.2006.07.014.

Reference Type: BACKGROUND

PMID: 17132481 (View on PubMed)

Kociszewski J, Rautenberg O, Perucchini D, Eberhard J, Geissbuhler 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.

Reference Type: BACKGROUND

PMID: 18288705 (View on PubMed)

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. doi: 10.1016/j.ajog.2006.07.009.

Reference Type: BACKGROUND

PMID: 17132484 (View on PubMed)

McGuire EJ, Lytton B. Pubovaginal sling procedure for stress incontinence. 1978. J Urol. 2002 Feb;167(2 Pt 2):1120-3; discussion 1124. doi: 10.1016/s0022-5347(02)80355-x. No abstract available.

Reference Type: BACKGROUND

PMID: 11905885 (View on PubMed)

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. Epub 2011 Feb 22.

Reference Type: BACKGROUND

PMID: 21344495 (View on PubMed)

Other Identifiers

206041

Identifier Type: -

Identifier Source: org_study_id