Phase
Condition
Enuresis
Urinary Incontinence
Treatment
RP Sling
SIS
Clinical Study ID
Ages > 21 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
At least 21 years of age
Vaginal bulge symptoms as indicated by an affirmative response of >1 to question 3of 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 withoutconcomitant hysterectomy)
Objective SUI: positive standardized cough stress test on clinical examination or onurodynamic study with reduced prolapse
Understanding and acceptance of the need to return for all scheduled follow-upvisits and willing to complete study questionnaires
Able to give informed consent
Exclusion
Exclusion Criteria:
Prior surgery for stress urinary incontinence including mid-urethral sling;Burch/MMK; fascial pubovaginal sling (autologous, xenograft or allograft); andurethral bulking injection
Any serious disease, or chronic condition, that could interfere with the studycompliance
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 prolapsereduction 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 perinealrectal prolapse surgery, rectovaginal fistula repair, hemorrhoidectomy
Pregnant or Planning to Conceive
Incarcerated
Study Design
Study Description
Connect with a study center
Pelvic Floor Foundation of South Africa, University of Cape Town
Cape Town, 8001
South AfricaSuspended
Florida Robotic and Minimally Invasive Urogynecology
Coconut Creek, Florida 33073
United StatesSite Not Available
Augusta University
Augusta, Georgia 30912
United StatesActive - Recruiting
Northwestern Medicine
Chicago, Illinois 60611
United StatesSite Not Available
University of Chicago
Chicago, Illinois 60637
United StatesActive - Recruiting
Boston Urogynecology Associates
Cambridge, Massachusetts 02138
United StatesActive - Recruiting
Atrium Health
Charlotte, North Carolina 28207
United StatesSite Not Available
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina 27101
United StatesActive - Recruiting
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