NCT04881721

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 8, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 11, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

August 25, 2021

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

March 13, 2023

Status Verified

March 1, 2023

Enrollment Period

2.4 years

First QC Date

April 8, 2021

Last Update Submit

March 9, 2023

Conditions

Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (5)

  • Distal Urethral Motion

    2 months

  • Distal Urethral Motion

    12 months

  • Proximal Urethral Motion

    2 months

  • Proximal Urethral Motion

    12 months

  • Post-operative complications

    Within 1 year of surgery

Interventions

UrethropexyPROCEDURE

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

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants with female pelvic anatomy, 18 years or older, with stress dominant urinary incontinence interested and eligible for surgical treatment

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NorthShore University HealthSystem

Skokie, Illinois, 60076, United States

Location

Related Publications (9)

  • 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.

    PMID: 28756647BACKGROUND

  • 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: 20479459BACKGROUND

  • 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: 25158274BACKGROUND

  • 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: 27094962BACKGROUND

  • 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: 18537142BACKGROUND

  • 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: 21925636BACKGROUND

  • 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: 16254676BACKGROUND

  • 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: 16145408BACKGROUND

  • 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.

    PMID: 11114559BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ghazaleh Rostami Nia, MD

    Endeavor Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Research Division of Urogynecology, NorthShore University HealthSystem

Study Record Dates

First Submitted

April 8, 2021

First Posted

May 11, 2021

Study Start

August 25, 2021

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

March 13, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)