Clinical trial NCT04881721: Mesh-free Suture Urethropexy for Treating Stress Urinary Incontinence, Efficacy and Durability Trial
Official title: Mesh-free Suture Urethropexy for Treating Stress Urinary Incontinence, Efficacy and Durability Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stress Urinary Incontinence
Lead sponsor: Endeavor Health
Sponsor class: OTHER
First posted: 2021-05-11
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with female pelvic anatomy, 18 years or older, with stress dominant urinary incontinence interested and eligible for surgical treatment

Brief summary: In this proposed study, the investigators aim to evaluate a modified suture urethropexy technique for the treatment of female stress urinary incontinence.

Participants will be followed with postoperative visits after 2 weeks, 2 months, and 12 months. Pelvic floor ultrasound imaging will be performed before surgery and after 2 months and 12 months, to evaluate urethral mobility.

Detailed description: This study is designed as a prospective observational study. The hypothesis is that suture urethropexy will improve stress urinary incontinence symptoms in participants with stress urinary incontinence and normal urethral closure pressure at 2 months and 12 months after surgery.

Specific Aims:

Aim 1: Investigate the efficacy of this mesh-free suture based surgical technique for improving SUI symptoms

Aim 2: Investigate the efficacy of this mesh-free suture based surgical technique on key urethral support defects observed with 3D ultrasound

Eligibility criteria: Inclusion Criteria:

* 18 years or older with stress dominant urinary incontinence
* Stress urinary incontinence confirmed by testing (e.g. urodynamics)
* Able to provide informed consent and attend post-operative visits

Exclusion Criteria:

* Detrusor overactivity (\> 40cm H2O)
* Maximum Urethral Closure Pressure (\< 40 cm H2O)
* Post void residual \> 150 mL
* Prior surgery for stress urinary incontinence with retained material (e.g. bulking agent, sling)

Primary outcomes:
measure: Stress urinary incontinence symptoms
timeFrame: 2 weeks
measure: Stress urinary incontinence symptoms
timeFrame: 3 months
measure: Stress urinary incontinence symptoms
timeFrame: 12 months
measure: Voiding dysfunction
timeFrame: Within 1 year of surgery
Secondary outcomes:
measure: Distal Urethral Motion
timeFrame: 2 months
measure: Distal Urethral Motion
timeFrame: 12 months
measure: Proximal Urethral Motion
timeFrame: 2 months
measure: Proximal Urethral Motion
timeFrame: 12 months
measure: Post-operative complications
timeFrame: Within 1 year of surgery
Other outcomes:
Locations:
city: Skokie
country: United States
facility: NorthShore University HealthSystem
state: Illinois
Study officials:
affiliation: Endeavor Health
name: Ghazaleh Rostami Nia, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ford AA, Rogerson L, Cody JD, Aluko P, Ogah JA. Mid-urethral sling operations for stress urinary incontinence in women. Cochrane Database Syst Rev. 2017 Jul 31;7(7):CD006375. doi: 10.1002/14651858.CD006375.pub4.
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: Nolfi AL, Brown BN, Liang R, Palcsey SL, Bonidie MJ, Abramowitch SD, Moalli PA. Host response to synthetic mesh in women with mesh complications. Am J Obstet Gynecol. 2016 Aug;215(2):206.e1-8. doi: 10.1016/j.ajog.2016.04.008. Epub 2016 Apr 16.
citation: Frenkl TL, Rackley RR, Vasavada SP, Goldman HB. Management of iatrogenic foreign bodies of the bladder and urethra following pelvic floor surgery. Neurourol Urodyn. 2008;27(6):491-5. doi: 10.1002/nau.20558.
citation: Brubaker L, Norton PA, Albo ME, Chai TC, Dandreo KJ, Lloyd KL, Lowder JL, Sirls LT, Lemack GE, Arisco AM, Xu Y, Kusek JW; Urinary Incontinence Treatment Network. Adverse events over two years after retropubic or transobturator midurethral sling surgery: findings from the Trial of Midurethral Slings (TOMUS) study. Am J Obstet Gynecol. 2011 Nov;205(5):498.e1-6. doi: 10.1016/j.ajog.2011.07.011. Epub 2011 Jul 20.
citation: Baracat F, Mitre AI, Kanashiro H, Montellato NI. Endoscopic treatment of vesical and urethral perforations after tension-free vaginal tape (TVT) procedure for female stress urinary incontinence. Clinics (Sao Paulo). 2005 Oct;60(5):397-400. doi: 10.1590/s1807-59322005000500008. Epub 2005 Oct 24.
citation: Giri SK, Drumm J, Flood HD. Endoscopic holmium laser excision of intravesical tension-free vaginal tape and polypropylene suture after anti-incontinence procedures. J Urol. 2005 Oct;174(4 Pt 1):1306-7. doi: 10.1097/01.ju.0000173926.04596.55.
citation: Koduri S, Goldberg RP, Sand PK. Transvaginal therapy of genuine stress incontinence. Urology. 2000 Dec 4;56(6 Suppl 1):23-7. doi: 10.1016/s0090-4295(00)00509-4.