E-TOMUS Extended Trial of Mid-Urethral slings

Overview

Status: Enrolling by invitation
Keywords: Stress Urinary Incontinence , Incontinence
IRB Number: 00033875
Specialty: Urogyn and Pelvic Reconstructive Surgery
Sub Specialties:

Brief Summary

E-TOMUS is an observational study of women who have completed participation in the Trial Of Mid-Urethral Slings (TOMUS), a randomized trial comparing retropubic and transobturator midurethral sling procedures in women undergoing surgery for stress urinary incontinence (SUI). The TOMUS study follows participants for 2-years after surgery. Since 2- years is too short to evaluate long-term sequelae of the procedures, the goal of E-TOMUS is to follow participants for 5 additional years to compare the long-term continence rates, complication rates and overall pelvic floor outcomes of the two procedures.

This is a 5 year follow up study for women who have completed 2 years of research visits for the Trial Of Mid-Urethral Slings (TOMUS). The purpose of this study is to follow women in TOMUS for up to 5 additional years to monitor the long term effects of mesh insertion in women with urinary incontinence who were in a randomized surgical trial comparing two minimally invasive sling procedures for the treatment of urinary incontinence. In this way, we will learn more about how midurethral sling surgery to treat urinary incontinence affects women over a long period of time.
 
Starting in the third year after surgery, participants will be asked to return for an annual in-person visit with our study team. At each yearly visit, participants will complete questionnaires about urinary symptoms, sexual function, quality of life, and satisfaction with the results of their surgery. These are the same questionnaires that the participant completed before and after their incontinence surgery in TOMUS. A pelvic (internal) exam will be done by a member of the study team. This exam will be similar to the one performed as part of TOMUS. During the pelvic exam, participants will be asked to bear down and measurements will be taken to determine weaknesses in the vaginal support. In addition, the health care provider will check to ensure that participants do not have a piece of the sling material exposed in the vagina. Participants will be asked to provide a clean catch urine sample, which will be checked for infection and we wil check how much urine is left in the patients bladder after urination. This may be done by passing a small catheter into the patients bladder or by scanning the bladder with an ultrasound depending on the health providers practice. All study visits will take about one hour.

If participants are unable to attend some of the study visits for the pelvic exam, we welcome their participation in the study by having them complete the self-administered questionnaires. This will be done by mail or by telephone.

 


 

Principal Investigator: Peggy Norton
Department: Urogynecology
Co Investigator: Ingrid Nygaard
Co Investigator: Jan Baker

Contact Information

Name:Heather Bogucki
Phone: 801-5873069
Email: heather.bogucki@hsc.utah.edu

Inclusion Criteria

1. The study population will consist of TOMUS patients who have not undergone any surgical retreatment for SUI and who consent to extended follow-up.
 
2. Signed Consent Form.

Exclusion Criteria

Surgical retreatment for SUI.