Mesh-free Suture Urethropexy for Treating Stress Urinary Incontinence, Efficacy and Durability Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: Procedure: Urethropexy

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

• Study Type: Observational
• Enrollment (Anticipated): 15

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Skokie, Illinois, United States, 60076
      • NorthShore University Healthsystem

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stress urinary incontinence symptoms	Severity of stress urinary incontinence symptoms by questionnaire	2 weeks
Stress urinary incontinence symptoms	Severity of stress urinary incontinence symptoms by questionnaire	3 months
Stress urinary incontinence symptoms	Severity of stress urinary incontinence symptoms by questionnaire	12 months
Voiding dysfunction	Rate of urinary retention after surgery	Within 1 year of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distal Urethral Motion	Distal urethral swing angle during Valsalva measured via pelvic ultrasound	2 months
Distal Urethral Motion	Distal urethral swing angle during Valsalva measured via pelvic ultrasound	12 months
Proximal Urethral Motion	Proximal urethral swing angle during Valsalva measured via pelvic ultrasound	2 months
Proximal Urethral Motion	Proximal urethral swing angle during Valsalva measured via pelvic ultrasound	12 months
Post-operative complications	Rate of post-operative complications	Within 1 year of surgery

Collaborators and Investigators

• Sponsor: NorthShore University HealthSystem

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2021
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: April 8, 2021
• First Submitted That Met QC Criteria: May 10, 2021
• First Posted (Actual): May 11, 2021

Study Record Updates

• Last Update Posted (Actual): March 13, 2023
• Last Update Submitted That Met QC Criteria: March 9, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: EH21-062

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No