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

SASS: Randomized Trial of Single-incision Versus Retropubic Mid-Urethral Sling (Solyx) for Concomitant Management of Stress Urinary Incontinence During Minimally Invasive Sacrocolpopexy

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.

Study Overview

• Status: Recruiting
• Conditions: Stress Urinary Incontinence; Pelvic Floor Disorders
• Intervention / Treatment: Device: RP Sling; Device: SIS

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 Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sachin N Vyas, MS,PhD; Phone Number: 336-713-4098; Email: svyas@wakehealth.edu
• Study Contact Backup: Name: Catherine A Matthews, MD

Study Locations

• South Africa
  • Cape Town, South Africa, 8001
    • Recruiting
    • Pelvic Floor Foundation of South Africa, University of Cape Town
    • Contact: Christelle De Koker; Phone Number: 27-64-650-6199; Email: christelle.dekoker@uct.ac.za
    • Principal Investigator: Stephen Jeffery, MD
• United States
  • Florida
    • Coconut Creek, Florida, United States, 33073
      • Recruiting
      • Florida Robotic and Minimally Invasive Urogynecology
      • Contact: Karen Brocki; Phone Number: 954-570-7644
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Recruiting
      • Augusta University
      • Contact: Torri Blackmon; Phone Number: 706-721-1088; Email: TBlackm2@augusta.edu
      • Principal Investigator: Jennifer Lanzer, MD
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern Medicine
      • Contact: Sophia Kallas, BS, BA, BMS; Phone Number: 312-926-7846; Email: sophia.kallas@nm.org
      • Principal Investigator: Julia Geynisman-Tan, MD
  • Massachusetts
    • Cambridge, Massachusetts, United States, 02138
      • Recruiting
      • Boston Urogynecology Associates
      • Contact: Peter L Rosenblatt; Phone Number: 617-354-5452
      • Principal Investigator: Peter L Rosenblatt, MD
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27101
      • Recruiting
      • Wake Forest Baptist Medical Center
      • Principal Investigator: Catherine A Matthews, MD
      • Contact: Sachin N Vyas, MS,PhD; Phone Number: 336-713-4098

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
Number of Participants needing bladder drainage	Requirement of urinary catheter due to incontinence or retention	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.	Baseline, Surgery, Post Op: week 2, week 6, year 1, year 2, year 3, and year 5

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: Boston Scientific Corporation
• Investigators: Principal Investigator: Catherine A Matthews, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2020
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: October 7, 2020
• First Submitted That Met QC Criteria: October 13, 2020
• First Posted (Actual): October 14, 2020

Study Record Updates

• Last Update Posted (Actual): June 29, 2023
• Last Update Submitted That Met QC Criteria: June 27, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Sacrocolpopexy; Retropubic Sling; Single-Incision Sling
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Pregnancy Complications; Elimination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress; Pelvic Floor Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Imidacloprid
• Other Study ID Numbers: IRB00068839

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Only limited dataset without PHI will be shared with the study bio statistical group.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes