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

Launched by WAKE FOREST UNIVERSITY HEALTH SCIENCES · Oct 13, 2020

Keywords

ClinConnect Summary

The SASS trial is comparing two types of surgical procedures to treat stress urinary incontinence (SUI) in women who also have pelvic floor disorders. Specifically, it looks at a single-incision sling versus a retropubic mid-urethral sling. Stress urinary incontinence is when a person leaks urine during activities like coughing, sneezing, or exercising. This study aims to see if one method is as effective as the other while women undergo a minimally invasive procedure called sacrocolpopexy, which helps support the pelvic organs.

To participate in this trial, women must be at least 21 years old and experience symptoms of pelvic organ prolapse, along with objective signs of stress urinary incontinence. They should be willing to return for follow-up visits and complete study questionnaires. Participants can expect to receive care related to their condition and contribute to important research that could help improve treatment options for other women in the future. It's important to know that women with certain health conditions or prior surgeries for stress urinary incontinence may not be eligible for this study.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • At least 21 years of age
• • Vaginal bulge symptoms as indicated by an affirmative response of \>1 to question 3 of the PFDI-SF20
• • POP ≥ stage II according to the pelvic organ prolapse quantification (POP-Q) system45, with evidence of apical descent
• • Women being considered for minimally invasive sacrocolpopexy (with or without concomitant hysterectomy)
• • Objective SUI: positive standardized cough stress test on clinical examination or on urodynamic study with reduced prolapse
• • Understanding and acceptance of the need to return for all scheduled follow-up visits and willing to complete study questionnaires
• • Able to give informed consent
• Exclusion Criteria:
• • Prior surgery for stress urinary incontinence including mid-urethral sling; Burch/MMK; fascial pubovaginal sling (autologous, xenograft or allograft); and urethral bulking injection
• • Any serious disease, or chronic condition, that could interfere with the study compliance
• • Unwilling to have a synthetic sling
• • Untreated and unresolved urinary tract infection
• • Poorly-controlled diabetes mellitus (HgbA1c \> 9 within 3 months of surgery date)
• • Neurogenic bladder/ pre-operative self-catheterization
• • Elevated post-void residual/PVR (\>150 ml) that does not resolve with prolapse reduction testing (pessary, prolapse reduced uroflow or micturition study)
• • Prior pelvic radiation
• • Inflammatory bowel disease
• • Current genitourinary fistula or urethral diverticulum
• • Planned concomitant bowel related surgery including sphincteroplasty and perineal rectal prolapse surgery, rectovaginal fistula repair, hemorrhoidectomy
• • Pregnant or Planning to Conceive
• • Incarcerated