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.
SASS aims to compare the efficacy of a single-incision (SIS) versus a retropubic mid-urethral sling (RP) placed at the time of minimally invasive sacrocolpopexy in women with pelvic organ prolapse and objectively confirmed stress urinary incontinence (SUI).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
180
Florida Robotic and Minimally Invasive Urogynecology
Coconut Creek, Florida, United States
ACTIVE_NOT_RECRUITINGAugusta University
Augusta, Georgia, United States
RECRUITINGNorthwestern Medicine
Chicago, Illinois, United States
Number of participants with subjectively bothersome stress incontinence
Measured by a positive response of \> 1 to Question 17 on Pelvic Floor Distress Inventory short form-20 (PFDI-20). Response scale from 0 to 4. Symptoms Not Present = NO 0 = not present Symptoms Present = YES, scale of bother: 1 = not at all, 2 = somewhat, 3 = moderately, 4 = quite a bit
Time frame: 6 weeks after surgery
Number of participants with subjectively bothersome stress incontinence
Measured by a positive response of \> 1 to Question 17 on Pelvic Floor Distress Inventory short form-20 (PFDI-20). Response scale from 0 to 4. Symptoms Not Present = NO 0 = not present Symptoms Present = YES, scale of bother: 1 = not at all, 2 = somewhat, 3 = moderately, 4 = quite a bit
Time frame: 1 year after surgery
Number of participants with subjectively bothersome stress incontinence
Measured by a positive response of \> 1 to Question 17 on Pelvic Floor Distress Inventory short form-20 (PFDI-20). Response scale from 0 to 4. Symptoms Not Present = NO 0 = not present Symptoms Present = YES, scale of bother: 1 = not at all, 2 = somewhat, 3 = moderately, 4 = quite a bit
Time frame: 3 years after surgery
Number of participants with subjectively bothersome stress incontinence
Measured by a positive response of \> 1 to Question 17 on Pelvic Floor Distress Inventory short form-20 (PFDI-20). Response scale from 0 to 4. Symptoms Not Present = NO 0 = not present Symptoms Present = YES, scale of bother: 1 = not at all, 2 = somewhat, 3 = moderately, 4 = quite a bit
Time frame: 5 years after surgery
VAS (Visual Analogue Scale Surgeon ease of Use)
This will be assessed using the numeric rating scale (NRS). The score is 0-10, with higher scores denoting a greater degree of satisfaction.
Catherine A Matthews, MD
CONTACT
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University of Chicago
Chicago, Illinois, United States
RECRUITINGBoston Urogynecology Associates
Cambridge, Massachusetts, United States
RECRUITINGWake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
RECRUITINGPelvic Floor Foundation of South Africa, University of Cape Town
Cape Town, South Africa
SUSPENDEDTime frame: Baseline, Surgery, Post Op: week 2, week 6, year 1, year 2, year 3, and year 5
Pelvic Organ Prolapse/Urinary Incontinence Sexual Functioning Short Form (PISQ-IR)
Questionnaire consists of 20 questions regarding sexual functioning. PISQ-IR consists of two parts. Part 1, for not Sexually Active (NSA) women, and par 2 for SA women. Response value varies from 1 to 5. Part 1, for not SA (NSA) women, where higher scores indicate a greater impact of the condition on sexual inactivity. Part 2, for SA women, with higher scores indicating better sexual function.
Time frame: Baseline, Surgery, Post Op: week 2, week 6, year 1, year 2, year 3, and year 5
Pelvic Floor Impact (PFIQ-SF7)
Consists of 3 scales with each 7 questions and will be used to assess quality of life regarding pelvic floor related quality of life. The total score is the sum of the three scale score with a range of 0-300. Higher values indicate a greater degree of bother
Time frame: Baseline, Surgery, Post Op: week 2, week 6, year 1, year 2, year 3, and year 5
Patient Global Impression of Improvement (PGI-I)
7-point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative baseline - lower scores denote improvement - 1= Very much better to 7 = Very much worse
Time frame: Baseline, Surgery, Post Op: week 2, week 6, year 1, year 2, year 3, and year 5
Assessment of post-void residual (PVR) volume
Post Void Residual/PVR measurement - (collected via bladder scan or CIC) (Clean Intermittent Catheterization). PVR can be as minimum as 0ml of an average bladder capacity of 400ml
Time frame: Baseline, Surgery, Post Op: week 2, week 6, year 1, year 2, year 3, and year 5
Number of Participants needing Retreatment
Surgical intervention for urinary retention (sling lysis) at any time point after surgery
Time frame: 6 month up to 5 year post-surgery
Number of Participants needing bladder drainage
Requirement of urinary catheter due to incontinence or retention
Time frame: beyond 6 weeks post-surgery
Pelvic Floor Distress Inventory (PFDI-SF20)
The PFDI-20 has a total of 20 questions and 3 scales (Urinary Distress Inventory, Pelvic Organ Prolapse Distress Inventory, and Colorectal-Anal Distress Inventory). The outcomes of this questionnaire will be evaluated stratified by compartment. Each item produces a response of 0 to 4, the average response in each scale is multiplied by 25 to obtain the scale score (range 0 to 100). The total score is the sum of the three scale score with a range of 0-300. Higher values indicate a greater degree of bother.
Time frame: Baseline, Surgery, Post Op: week 2, week 6, year 1, year 2, year 3, and year 5