Mesh-Reduced Sling For Treating Stress Urinary Incontinence, Efficacy and Durability Trial

NCT05842005 | Unknown DMC FDA Device

• 1 other identifier: EH22-464
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this pilot study is to report the safety and efficacy of a suture-suspended mesh-reduced sling for treating stress urinary incontinence (SUI) in women. The main question\[s\] it aims to answer are:

• investigate the efficacy of this mesh-reduced suture-based surgical technique for improving SUI symptoms
• investigate the efficacy of this mesh-reduced suture-based surgical technique on key urethral support defects observed with 3D ultrasound Participants will consent to participate following which they will complete pre-operative assessments according to our routine clinical pathway. The participant will then undergo surgery and will be followed up to 12 months post-operatively via symptom assessment and pelvic exam.

Conditions

Stress Urinary Incontinence

Keywords

Mesh-reduced sling; Safety; Efficacy; Treatment

Outcome Measures

Primary Outcomes (1)

• PFDI-20 score

  Pelvic Floor Disability Index (PFDI-20) score indicating SUI symptom severity. Higher values indicate greater distress or worse outcome. The sub-scales score ranges from 0 to 100. The summary score ranges from 0 to 300.

  12 months post-op

Secondary Outcomes (3)

• Complication measured by distal urethral swing angle

  12 months post-op

• Complication measured by proximal urethral swing angle

  12 months post-op

• Complication measured by early and remote post-operative complications

  12 months post-op

Study Arms (1)

Mesh-reduced Sling

EXPERIMENTAL

Mesh-reduced sling will improve stress urinary incontinence (SUI) symptoms in women with SUI and normal urethral closure pressure at 2 months and 12 months after surgery.

Device: Mesh-reduced Sling

Interventions

Mesh-reduced Sling DEVICE

In this proposed study, the investigators aim to evaluate the role of using a ¾ x ⅜ inch cm polypropylene mesh suspended by sutures as a mesh-reduced solution for SUI.

Mesh-reduced Sling

Eligibility Criteria

• Age: 45 Years - 100 Years
• Gender Eligibility Details: Stress urinary incontinence in women.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptomatic stress urinary incontinence

You may not qualify if:

• Women of childbearing age (0-45 years)
• Previous stress urinary incontinence surgery

Sponsors & Collaborators

• Endeavor Health: lead

Study Sites (1)

NorthShore University Health System

Skokie, Illinois, 60076, United States

RECRUITING

Related Publications (14)

• Ford AA, Rogerson L, Cody JD, Ogah J. Mid-urethral sling operations for stress urinary incontinence in women. Cochrane Database Syst Rev. 2015 Jul 1;(7):CD006375. doi: 10.1002/14651858.CD006375.pub3.

  PMID: 26130017 BACKGROUND

• 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.

  PMID: 20479459 BACKGROUND

• 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.

  PMID: 25158274 BACKGROUND

• 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.

  PMID: 27094962 BACKGROUND

• 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.

  PMID: 18537142 BACKGROUND

• 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.

  PMID: 21925636 BACKGROUND

• 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.

  PMID: 16254676 BACKGROUND

• 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.

  PMID: 16145408 BACKGROUND

• Molden SM, Lucente VR. New minimally invasive slings: TVT Secur. Curr Urol Rep. 2008 Sep;9(5):358-61. doi: 10.1007/s11934-008-0062-8.

  PMID: 18702918 BACKGROUND

• Palma P, Riccetto C, Bronzatto E, Castro R, Altuna S. What is the best indication for single-incision Ophira Mini Sling? Insights from a 2-year follow-up international multicentric study. Int Urogynecol J. 2014 May;25(5):637-43. doi: 10.1007/s00192-013-2242-4. Epub 2013 Oct 30.

  PMID: 24170223 BACKGROUND

• Talley NJ, Weaver AL, Zinsmeister AR, Melton LJ 3rd. Functional constipation and outlet delay: a population-based study. Gastroenterology. 1993 Sep;105(3):781-90. doi: 10.1016/0016-5085(93)90896-k.

  PMID: 8359649 BACKGROUND

• Talley NJ, Fleming KC, Evans JM, O'Keefe EA, Weaver AL, Zinsmeister AR, Melton LJ 3rd. Constipation in an elderly community: a study of prevalence and potential risk factors. Am J Gastroenterol. 1996 Jan;91(1):19-25.

  PMID: 8561137 BACKGROUND

• Riss S, Stift A. Surgery for obstructed defecation syndrome - is there an ideal technique. World J Gastroenterol. 2015 Jan 7;21(1):1-5. doi: 10.3748/wjg.v21.i1.1.

  PMID: 25574075 BACKGROUND

• Bordeianou L, Paquette I, Johnson E, Holubar SD, Gaertner W, Feingold DL, Steele SR. Clinical Practice Guidelines for the Treatment of Rectal Prolapse. Dis Colon Rectum. 2017 Nov;60(11):1121-1131. doi: 10.1097/DCR.0000000000000889. No abstract available.

  PMID: 28991074 BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Henry Chill, MD

  Endeavor Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Henry Chill, MD

CONTACT

(224)-251-2374; HChill@northshore.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study is designed as a prospective case series. Our hypothesis is that the mesh-reduced sling will improve stress urinary incontinence (SUI) symptoms in women with SUI and normal urethral closure pressure at 2 months and 12 months after surgery.

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: May 3, 2023
• Study Start: January 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 3, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will become available during data collection until after publication.
• Access Criteria: Other investigators within NorthShore University Health System who are listed on the study delegation log will receive individual participant data during data collection for use during data analysis.

Locations

US (1)