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

Sponsor

Wake Forest University Health Sciences (Other)

Overall Status

Recruiting

CT.gov ID

NCT04586166

Collaborator

Boston Scientific Corporation (Industry)

180

Enrollment

Locations

Arms

95.3

Anticipated Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stress Urinary Incontinence Pelvic Floor Disorders	Device: RP Sling Device: SIS	N/A

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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

180 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

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.

Primary Purpose:

Treatment

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

Actual Study Start Date :

Dec 23, 2020

Anticipated Primary Completion Date :

Jun 1, 2028

Anticipated Study Completion Date :

Dec 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental: RP Sling Group Participants assigned to the retropubic (RP) sling group will have the RP sling placement procedure	Device: RP Sling Participants assigned to the retropubic (RP) sling group will have the RP sling placement procedure. Other Names: Advantage RP Sling
Experimental: SIS Group Participants assigned to the single-incision sling (SIS) group will have the SIS placement procedure	Device: SIS Participants assigned to the single-incision sling (SIS) group will have the SIS placement procedure. Other Names: Solyx SIS System

Arm

Intervention/Treatment

Experimental: RP Sling Group

Participants assigned to the retropubic (RP) sling group will have the RP sling placement procedure

Device: RP Sling

Participants assigned to the retropubic (RP) sling group will have the RP sling placement procedure.

Other Names:

Advantage RP Sling

Experimental: SIS Group

Participants assigned to the single-incision sling (SIS) group will have the SIS placement procedure

Device: SIS

Participants assigned to the single-incision sling (SIS) group will have the SIS placement procedure.

Other Names:

Solyx SIS System

Outcome Measures

Primary Outcome Measures

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
Number of participants with subjectively bothersome stress incontinence [1 year 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
Number of participants with subjectively bothersome stress incontinence [3 years 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
Number of participants with subjectively bothersome stress incontinence [5 years 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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Florida Robotic and Minimally Invasive Urogynecology	Coconut Creek	Florida	United States	33073
2	Augusta University	Augusta	Georgia	United States	30912
3	Northwestern Medicine	Chicago	Illinois	United States	60611
4	Boston Urogynecology Associates	Cambridge	Massachusetts	United States	02138
5	Wake Forest Baptist Medical Center	Winston-Salem	North Carolina	United States	27101
6	Pelvic Floor Foundation of South Africa, University of Cape Town	Cape Town		South Africa	8001