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

Stress Urinary Incontinence Clinical Trial

— SASS  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04586166
• Other study ID #: IRB00068839
• Status: Recruiting
• Phase: N/A
• Start date: December 23, 2020
• Est. completion date: December 2032

Study information

• Verified date: May 2024
• Source: Wake Forest University Health Sciences
• Contact: Sachin N Vyas, MS,PhD
• Phone: 336-713-4098
• Email: svyas[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 2032
• Est. primary completion date: December 2031
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Pelvic Floor Disorders
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Device:
• RP Sling
Participants assigned to the retropubic (RP) sling group will have the RP sling placement procedure.
• SIS
Participants assigned to the single-incision sling (SIS) group will have the SIS placement procedure.

Locations

Country	Name	City	State
South Africa	Pelvic Floor Foundation of South Africa, University of Cape Town	Cape Town
United States	Augusta University	Augusta	Georgia
United States	Boston Urogynecology Associates	Cambridge	Massachusetts
United States	Northwestern Medicine	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
United States	Florida Robotic and Minimally Invasive Urogynecology	Coconut Creek	Florida
United States	Wake Forest Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 weeks after surgery
Primary	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	1 year after surgery
Primary	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	3 years after surgery
Primary	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	5 years after surgery
Secondary	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.	Baseline, Surgery, Post Op: week 2, week 6, year 1, year 2, year 3, and year 5
Secondary	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.	Baseline, Surgery, Post Op: week 2, week 6, year 1, year 2, year 3, and year 5
Secondary	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	Baseline, Surgery, Post Op: week 2, week 6, year 1, year 2, year 3, and year 5
Secondary	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	Baseline, Surgery, Post Op: week 2, week 6, year 1, year 2, year 3, and year 5
Secondary	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	Baseline, Surgery, Post Op: week 2, week 6, year 1, year 2, year 3, and year 5
Secondary	Number of Participants needing Retreatment	Surgical intervention for urinary retention (sling lysis) at any time point after surgery	6 month up to 5 year post-surgery
Secondary	Number of Participants needing bladder drainage	Requirement of urinary catheter due to incontinence or retention	beyond 6 weeks post-surgery
Secondary	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.	Baseline, Surgery, Post Op: week 2, week 6, year 1, year 2, year 3, and year 5