The Effect of Mid-urethral Sling on the Urethral Dynamic Shape and Motion

NCT04843995 | Completed

• 1 other identifier: EH21-027
• Study Type: observational
• Target: 190
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this prospective cohort study is to investigate the effect of sling on urethral dynamic shape and motion using static and dynamic pelvic floor ultrasound and additionally compare the findings among women with successful vs failed surgical outcome.

Conditions

Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (4)

• Urethral Shape at 3 months

  Urethral shape measured by ultrasound

  3 months

• Urethral Motion at 3 months

  Urethral motion measured by ultrasound

  3 months

• Urethral Shape at 12 months

  Urethral shape measured by ultrasound

  12 months

• Urethral Motion at 12 months

  Urethral motion measured by ultrasound

  12 months

Interventions

Mid-urethral sling PROCEDURE

Treatment of stress urinary incontinence with retropubic mid-urethral sling

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women over 18 years old with stress urinary incontinence interested in treatment with midurethral sling

You may qualify if:

• stress urinary incontinence interested in treatment with mid-urethral sling
• able to consent in english and come to post-operative and research visits

You may not qualify if:

• contraindication to mid-urethral sling
• detrusor overactivity \> 40cm H2O
• post-void residual \> 150mL
• Maximum urethral closure pressure \< 40 cm H2O

Sponsors & Collaborators

• Endeavor Health: lead

Study Sites (1)

NorthShore University HealthSystem

Skokie, Illinois, 60076, United States

Location

Related Publications (10)

• Richter HE, Albo ME, Zyczynski HM, Kenton K, Norton PA, Sirls LT, Kraus SR, Chai TC, Lemack GE, Dandreo KJ, Varner RE, Menefee S, Ghetti C, Brubaker L, Nygaard I, Khandwala S, Rozanski TA, Johnson H, Schaffer J, Stoddard AM, Holley RL, Nager CW, Moalli P, Mueller E, Arisco AM, Corton M, Tennstedt S, Chang TD, Gormley EA, Litman HJ; Urinary Incontinence Treatment Network. Retropubic versus transobturator midurethral slings for stress incontinence. N Engl J Med. 2010 Jun 3;362(22):2066-76. doi: 10.1056/NEJMoa0912658. Epub 2010 May 17.

  PMID: 20479459 BACKGROUND

• Kenton K, Stoddard AM, Zyczynski H, Albo M, Rickey L, Norton P, Wai C, Kraus SR, Sirls LT, Kusek JW, Litman HJ, Chang RP, Richter HE. 5-year longitudinal followup after retropubic and transobturator mid urethral slings. J Urol. 2015 Jan;193(1):203-10. doi: 10.1016/j.juro.2014.08.089. Epub 2014 Aug 23.

  PMID: 25158274 BACKGROUND

• Brubaker L, Richter HE, Norton PA, Albo M, Zyczynski HM, Chai TC, Zimmern P, Kraus S, Sirls L, Kusek JW, Stoddard A, Tennstedt S, Gormley EA; Urinary Incontinence Treatment Network. 5-year continence rates, satisfaction and adverse events of burch urethropexy and fascial sling surgery for urinary incontinence. J Urol. 2012 Apr;187(4):1324-30. doi: 10.1016/j.juro.2011.11.087. Epub 2012 Feb 15.

  PMID: 22341290 BACKGROUND

• Albo ME, Richter HE, Brubaker L, Norton P, Kraus SR, Zimmern PE, Chai TC, Zyczynski H, Diokno AC, Tennstedt S, Nager C, Lloyd LK, FitzGerald M, Lemack GE, Johnson HW, Leng W, Mallett V, Stoddard AM, Menefee S, Varner RE, Kenton K, Moalli P, Sirls L, Dandreo KJ, Kusek JW, Nyberg LM, Steers W; Urinary Incontinence Treatment Network. Burch colposuspension versus fascial sling to reduce urinary stress incontinence. N Engl J Med. 2007 May 24;356(21):2143-55. doi: 10.1056/NEJMoa070416. Epub 2007 May 21.

  PMID: 17517855 BACKGROUND

• Hunskaar S, Lose G, Sykes D, Voss S. The prevalence of urinary incontinence in women in four European countries. BJU Int. 2004 Feb;93(3):324-30. doi: 10.1111/j.1464-410x.2003.04609.x.

  PMID: 14764130 BACKGROUND

• Wong V, Shek KL. The mesh debate: Transvaginal anterior anchored mesh should not be abandoned. Aust N Z J Obstet Gynaecol. 2017 Feb;57(1):105-107. doi: 10.1111/ajo.12589. No abstract available.

  PMID: 28251634 BACKGROUND

• Ling C, Shek KL, Gillor M, Caudwell-Hall J, Dietz HP. Is location of urethral kinking a confounder of association between urethral closure pressure and stress urinary incontinence? Ultrasound Obstet Gynecol. 2021 Mar;57(3):488-492. doi: 10.1002/uog.22153.

  PMID: 32672377 BACKGROUND

• Tamma A, Bjelic-Radisic V, Holbfer S, Trutnovsky G, Tamussino K, Aigmuller T, Ulrich D. Sonographic sling position and cure rate 10-years after TVT- O procedure. PLoS One. 2019 Jan 7;14(1):e0209668. doi: 10.1371/journal.pone.0209668. eCollection 2019.

  PMID: 30615677 BACKGROUND

• Milley PS, Nichols DH. The relationship between the pubo-urethral ligaments and the urogenital diaphragm in the human female. Anat Rec. 1971 Jul;170(3):281-3. doi: 10.1002/ar.1091700304. No abstract available.

  PMID: 5104318 BACKGROUND

• Stein TA, DeLancey JO. Structure of the perineal membrane in females: gross and microscopic anatomy. Obstet Gynecol. 2008 Mar;111(3):686-93. doi: 10.1097/AOG.0b013e318163a9a5.

  PMID: 18310372 BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

Suburethral Slings

Condition Hierarchy (Ancestors)

Urinary Incontinence; 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

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Officials

• Joel D Winer, MD

  Endeavor Health

  PRINCIPAL INVESTIGATOR

• Ghazaleh Rostami Nia, MD

  Endeavor Health

  STUDY CHAIR

• Henry Chill, MD

  Endeavor Health

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: April 14, 2021
• Study Start: June 11, 2012
• Primary Completion: May 12, 2021
• Study Completion: May 14, 2021
• Last Updated: March 1, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)