RECRUITING

Single-incision Versus Retropubic Mid-Urethral Sling (Solyx) for SUI During Minimally Invasive Sacrocolpopexy

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Conditions

Stress Urinary IncontinencePelvic Floor DisordersRetropubic SlingSingle-Incision SlingSacrocolpopexy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

SASS (Single-incision Versus Retropubic Mid-Urethral Sling (Solyx) for SUI During Minimally Invasive Sacrocolpopexy) will be a multicenter, prospective, randomized, single-blind non-inferiority trial.

Official Title

SASS: Randomized Trial of Single-incision Versus Retropubic Mid-Urethral Sling (Solyx) for Concomitant Management of Stress Urinary Incontinence During Minimally Invasive Sacrocolpopexy

Quick Facts

Study Start:2020-12-23
Study Completion:2032-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04586166

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * At least 21 years of age
  2. * Vaginal bulge symptoms as indicated by an affirmative response of \>1 to question 3 of the PFDI-SF20
  3. * POP ≥ stage II according to the pelvic organ prolapse quantification (POP-Q) system45, with evidence of apical descent
  4. * Women being considered for minimally invasive sacrocolpopexy (with or without concomitant hysterectomy)
  5. * Objective SUI: positive standardized cough stress test on clinical examination or on urodynamic study with reduced prolapse
  6. * Understanding and acceptance of the need to return for all scheduled follow-up visits and willing to complete study questionnaires
  7. * Able to give informed consent
  1. * Prior surgery for stress urinary incontinence including mid-urethral sling; Burch/MMK; fascial pubovaginal sling (autologous, xenograft or allograft); and urethral bulking injection
  2. * Any serious disease, or chronic condition, that could interfere with the study compliance
  3. * Unwilling to have a synthetic sling
  4. * Untreated and unresolved urinary tract infection
  5. * Poorly-controlled diabetes mellitus (HgbA1c \> 9 within 3 months of surgery date)
  6. * Neurogenic bladder/ pre-operative self-catheterization
  7. * Elevated post-void residual/PVR (\>150 ml) that does not resolve with prolapse reduction testing (pessary, prolapse reduced uroflow or micturition study)
  8. * Prior pelvic radiation
  9. * Inflammatory bowel disease
  10. * Current genitourinary fistula or urethral diverticulum
  11. * Planned concomitant bowel related surgery including sphincteroplasty and perineal rectal prolapse surgery, rectovaginal fistula repair, hemorrhoidectomy
  12. * Pregnant or Planning to Conceive
  13. * Incarcerated

Contacts and Locations

Study Contact

Sachin N Vyas, MS,PhD
CONTACT
336-713-4098
svyas@wakehealth.edu
Catherine A Matthews, MD
CONTACT

Principal Investigator

Catherine A Matthews, MD
PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences

Study Locations (Sites)

Florida Robotic and Minimally Invasive Urogynecology
Coconut Creek, Florida, 33073
United States
Augusta University
Augusta, Georgia, 30912
United States
Northwestern Medicine
Chicago, Illinois, 60611
United States
University of Chicago
Chicago, Illinois, 60637
United States
Boston Urogynecology Associates
Cambridge, Massachusetts, 02138
United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27101
United States

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

  • Catherine A Matthews, MD, PRINCIPAL_INVESTIGATOR, Wake Forest University Health Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-12-23
Study Completion Date2032-12

Study Record Updates

Study Start Date2020-12-23
Study Completion Date2032-12

Terms related to this study

Keywords Provided by Researchers

  • Retropubic Sling
  • Single-Incision Sling
  • Sacrocolpopexy

Additional Relevant MeSH Terms

  • Stress Urinary Incontinence
  • Pelvic Floor Disorders