Precise Transvaginal Tape Placement Trial

NCT02101489 | Completed DMC

• 1 other identifier: 206041
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Urinary Incontinence; Urinary Incontinence

Keywords

TVT; Stress urinary incontinence

Outcome Measures

Primary Outcomes (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.

  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 Outcomes (3)

• Comparing urethral length measurement with the Foley catheter and 3D ultrasound.

  2 weeks

• Location change of mid-urethral slings from the time of surgery to 2 weeks after surgery.

  2 weeks

• Stratify the data based on patient race, BMI, prolapse and age

  6 weeks

Study Arms (2)

Intraop Foley catheter measurement

ACTIVE COMPARATOR

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

Other: Foley Catheter

Without intraop Foley cath measurement

NO INTERVENTION

20 women without intraoperative Foley catheter measurement of the urethral length

Interventions

Foley Catheter OTHER

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

Intraop Foley catheter measurement

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Loyola University: lead

Study Sites (1)

Loyola University Health System

Maywood, Illinois, 60153, United States

Location

Related 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. Epub 2011 Jul 20.

  PMID: 21944223 BACKGROUND

• 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.

  PMID: 20069417 BACKGROUND

• 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.

  PMID: 18535753 BACKGROUND

• 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.

  PMID: 23563892 BACKGROUND

• 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.

  PMID: 17132481 BACKGROUND

• 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.

  PMID: 18288705 BACKGROUND

• 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.

  PMID: 17132484 BACKGROUND

• 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.

  PMID: 11905885 BACKGROUND

• 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.

  PMID: 21344495 BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence, Stress; Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Elizabeth R Mueller, M.D.

  Loyola University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Associate Professor

Study Record Dates

• First Submitted: March 19, 2014
• First Posted: April 2, 2014
• Study Start: March 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: November 1, 2016
• Last Updated: March 1, 2017

Record last verified: 2017-02

Locations

US (1)