Mesh-free Suture Urethropexy for Treating Stress Urinary Incontinence, Efficacy and Durability Trial
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Outcome Measures
Primary Outcome Measures
- Stress urinary incontinence symptoms [2 weeks]
Severity of stress urinary incontinence symptoms by questionnaire
- Stress urinary incontinence symptoms [3 months]
Severity of stress urinary incontinence symptoms by questionnaire
- Stress urinary incontinence symptoms [12 months]
Severity of stress urinary incontinence symptoms by questionnaire
- Voiding dysfunction [Within 1 year of surgery]
Rate of urinary retention after surgery
Secondary Outcome Measures
- Distal Urethral Motion [2 months]
Distal urethral swing angle during Valsalva measured via pelvic ultrasound
- Distal Urethral Motion [12 months]
Distal urethral swing angle during Valsalva measured via pelvic ultrasound
- Proximal Urethral Motion [2 months]
Proximal urethral swing angle during Valsalva measured via pelvic ultrasound
- Proximal Urethral Motion [12 months]
Proximal urethral swing angle during Valsalva measured via pelvic ultrasound
- Post-operative complications [Within 1 year of surgery]
Rate of post-operative complications
Eligibility Criteria
Criteria
Inclusion Criteria:
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18 years or older with stress dominant urinary incontinence
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Stress urinary incontinence confirmed by testing (e.g. urodynamics)
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Able to provide informed consent and attend post-operative visits
Exclusion Criteria:
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Detrusor overactivity (> 40cm H2O)
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Maximum Urethral Closure Pressure (< 40 cm H2O)
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Post void residual > 150 mL
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Prior surgery for stress urinary incontinence with retained material (e.g. bulking agent, sling)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | NorthShore University HealthSystem | Skokie | Illinois | United States | 60076 |
Sponsors and Collaborators
- NorthShore University HealthSystem
Investigators
- Principal Investigator: Ghazaleh Rostami Nia, MD, NorthShore University HealthSystem
Study Documents (Full-Text)
None provided.More Information
Publications
- 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. Epub 2005 Oct 24.
- 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.
- 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:CD006375. doi: 10.1002/14651858.CD006375.pub4. Review.
- 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.
- 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.
- 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.
- Koduri S, Goldberg RP, Sand PK. Transvaginal therapy of genuine stress incontinence. Urology. 2000 Dec 4;56(6 Suppl 1):23-7.
- 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.
- 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.
- EH21-062