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

Stress Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04881721
• Other study ID #: EH21-062
• Status: Active, not recruiting
• Start date: August 25, 2021
• Est. completion date: December 31, 2023

Study information

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

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Urethropexy
Suture based (Mesh-free) surgery to stabilize the urethra for the treatment of stress urinary incontinence

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 (9)

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. — View 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. — View 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. — View 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. — View 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. — 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

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. — View 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. — 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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stress urinary incontinence symptoms	Severity of stress urinary incontinence symptoms by questionnaire	2 weeks
Primary	Stress urinary incontinence symptoms	Severity of stress urinary incontinence symptoms by questionnaire	3 months
Primary	Stress urinary incontinence symptoms	Severity of stress urinary incontinence symptoms by questionnaire	12 months
Primary	Voiding dysfunction	Rate of urinary retention after surgery	Within 1 year of surgery
Secondary	Distal Urethral Motion	Distal urethral swing angle during Valsalva measured via pelvic ultrasound	2 months
Secondary	Distal Urethral Motion	Distal urethral swing angle during Valsalva measured via pelvic ultrasound	12 months
Secondary	Proximal Urethral Motion	Proximal urethral swing angle during Valsalva measured via pelvic ultrasound	2 months
Secondary	Proximal Urethral Motion	Proximal urethral swing angle during Valsalva measured via pelvic ultrasound	12 months
Secondary	Post-operative complications	Rate of post-operative complications	Within 1 year of surgery