Pelvic Floor Disorders, Stress Urinary Incontinence
Conditions
Keywords
Retropubic Sling, Single-Incision Sling, Sacrocolpopexy
Brief summary
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.
Detailed description
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).
Interventions
DEVICERP Sling
Participants assigned to the retropubic (RP) sling group will have the RP sling placement procedure.
DEVICESIS
Participants assigned to the single-incision sling (SIS) group will have the SIS placement procedure.
Sponsors
Wake Forest University Health Sciences
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants will be masked during the five-year follow-up period. Precautions will be taken to minimize unmasking the study groups. Since RP (retropubic) slings require two suprapubic stab incisions, identical sham incision will also be performed in the SIS (Single-Incision Sling) group.
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with subjectively bothersome stress incontinence | 6 weeks after surgery | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VAS (Visual Analogue Scale Surgeon ease of Use) | Baseline, Surgery, Post Op: week 2, week 6, year 1, year 2, year 3, and year 5 | This will be assessed using the numeric rating scale (NRS). The score is 0-10, with higher scores denoting a greater degree of satisfaction. |
| Pelvic Organ Prolapse/Urinary Incontinence Sexual Functioning Short Form (PISQ-IR) | Baseline, Surgery, Post Op: week 2, week 6, year 1, year 2, year 3, and year 5 | 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. |
| Pelvic Floor Impact (PFIQ-SF7) | Baseline, Surgery, Post Op: week 2, week 6, year 1, year 2, year 3, and year 5 | 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 |
| Patient Global Impression of Improvement (PGI-I) | Baseline, Surgery, Post Op: week 2, week 6, year 1, year 2, year 3, and year 5 | 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 |
| Assessment of post-void residual (PVR) volume | Baseline, Surgery, Post Op: week 2, week 6, year 1, year 2, year 3, and year 5 | 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 |
| Number of Participants needing Retreatment | 6 month up to 5 year post-surgery | Surgical intervention for urinary retention (sling lysis) at any time point after surgery |
| Number of Participants needing bladder drainage | beyond 6 weeks post-surgery | Requirement of urinary catheter due to incontinence or retention |
| Pelvic Floor Distress Inventory (PFDI-SF20) | Baseline, Surgery, Post Op: week 2, week 6, year 1, year 2, year 3, and year 5 | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORCatherine A Matthews, MD
Wake Forest University Health Sciences
Outcome results
None listed