Clinical trial NCT04843995: The Effect of Mid-urethral Sling on the Urethral Dynamic Shape and Motion
Official title: The Effect of Mid-urethral Sling on the Urethral Dynamic Shape and Motion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stress Urinary Incontinence
Lead sponsor: Endeavor Health
Sponsor class: OTHER
First posted: 2021-04-14
Enrollment: 190
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women over 18 years old with stress urinary incontinence interested in treatment with midurethral sling

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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Urethral Shape at 3 months
timeFrame: 3 months
measure: Urethral Motion at 3 months
timeFrame: 3 months
measure: Urethral Shape at 12 months
timeFrame: 12 months
measure: Urethral Motion at 12 months
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Skokie
country: United States
facility: NorthShore University HealthSystem
state: Illinois
Study officials:
affiliation: Endeavor Health
name: Joel D Winer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Endeavor Health
name: Ghazaleh Rostami Nia, MD
role: STUDY_CHAIR
affiliation: Endeavor Health
name: Henry Chill, MD
role: STUDY_DIRECTOR
References:
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.
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.
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.
citation: 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.
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.
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.
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.
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.
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.
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.