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

Stress Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04843995
• Other study ID #: EH21-027
• Status: Completed
• Start date: June 11, 2012
• Est. completion date: May 14, 2021

Study information

• Verified date: February 2023
• Source: NorthShore University HealthSystem
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

This study is designed as a prospective cohort study. Our hypothesis is that mid-urethral sling provides backstop for excessive "swing motion" of distal urethra and helps with urethral compression along its luminal axis.

Aim 1: Investigate the effect of mid-urethral sling on the urethral shape at rest and maximum Valsalva, in other words dynamic urethral shape.

Aim 2: Compare the effect of mid-urethral sling on urethral dynamic shape in women with successful surgical outcome (absence of stress urinary incontinence at 3 and 12 months after the surgery) and women with surgical failure (presence of stress urinary incontinence at 3 and 12 months after the surgery).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: May 14, 2021
• Est. primary completion date: May 12, 2021
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• stress urinary incontinence interested in treatment with mid-urethral sling

• able to consent in english and come to post-operative and research visits

Exclusion Criteria:

• contraindication to mid-urethral sling

• detrusor overactivity > 40cm H2O

• post-void residual > 150mL

• Maximum urethral closure pressure < 40 cm H2O

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Mid-urethral sling
Treatment of stress urinary incontinence with retropubic mid-urethral sling

Locations

Country	Name	City	State
United States	NorthShore University HealthSystem	Skokie	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
NorthShore University HealthSystem

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: PLoS One. 2019 Feb 14;14(2):e0212597. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urethral Shape at 3 months	Urethral shape measured by ultrasound	3 months
Primary	Urethral Motion at 3 months	Urethral motion measured by ultrasound	3 months
Primary	Urethral Shape at 12 months	Urethral shape measured by ultrasound	12 months
Primary	Urethral Motion at 12 months	Urethral motion measured by ultrasound	12 months