Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT04586166

Single-incision Versus Retropubic Mid-Urethral Sling (Solyx) for SUI 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Stress Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Pelvic Floor Disorders Pregnancy Complications Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Florida Robotic and Minimally Invasive Urogynecology, Coconut Creek, Florida, United States

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RP Sling

Device

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

Other names: Advantage RP Sling

SIS

Device

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

Other names: Solyx SIS System

Primary outcomes

  1. Number of participants with subjectively bothersome stress incontinence

    Time frame: 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

  2. Number of participants with subjectively bothersome stress incontinence

    Time frame: 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

  3. Number of participants with subjectively bothersome stress incontinence

    Time frame: 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

  4. Number of participants with subjectively bothersome stress incontinence

    Time frame: 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 outcomes

  1. VAS (Visual Analogue Scale Surgeon ease of Use)

    Time frame: 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.

  2. Pelvic Organ Prolapse/Urinary Incontinence Sexual Functioning Short Form (PISQ-IR)

    Time frame: 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.

  3. Pelvic Floor Impact (PFIQ-SF7)

    Time frame: 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

  4. Patient Global Impression of Improvement (PGI-I)

    Time frame: 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

  5. Assessment of post-void residual (PVR) volume

    Time frame: 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

  6. Number of Participants needing Retreatment

    Time frame: 6 month up to 5 year post-surgery

    Surgical intervention for urinary retention (sling lysis) at any time point after surgery

  7. Number of Participants needing bladder drainage

    Time frame: beyond 6 weeks post-surgery

    Requirement of urinary catheter due to incontinence or retention

  8. Pelvic Floor Distress Inventory (PFDI-SF20)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • Boston Scientific Corporation

Registry information

Official study title

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

Acronym: SASS

Important dates

Study start
2020
Primary completion
2031
Study completion
2032
First posted
Oct 14, 2020
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.