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

NCT04586166 | Active Not Recruiting DMC FDA Device

• 1 other identifier: IRB00068839
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 5

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.

Conditions

Stress Urinary Incontinence; Pelvic Floor Disorders

Keywords

Retropubic Sling; Single-Incision Sling; Sacrocolpopexy

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• 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

• 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

• Pelvic Floor Impact (PFIQ-SF7)

  Baseline, Surgery, Post Op: week 2, week 6, year 1, year 2, year 3, and year 5

• Patient Global Impression of Improvement (PGI-I)

  Baseline, Surgery, Post Op: week 2, week 6, year 1, year 2, year 3, and year 5

• Assessment of post-void residual (PVR) volume

  Baseline, Surgery, Post Op: week 2, week 6, year 1, year 2, year 3, and year 5

Study Arms (2)

RP Sling Group

EXPERIMENTAL

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

Device: RP Sling

SIS Group

EXPERIMENTAL

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

Device: SIS

Interventions

RP Sling DEVICE

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

Also known as: Advantage RP Sling

RP Sling Group

SIS DEVICE

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

Also known as: Solyx SIS System

SIS Group

Eligibility Criteria

• Age: 21 Years+
• Gender Eligibility Details: Female patients with pelvic organ prolapse.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Boston Scientific Corporation: collaborator

Study Sites (5)

Florida Robotic and Minimally Invasive Urogynecology

Coconut Creek, Florida, 33073, United States

Location

Augusta University

Augusta, Georgia, 30912, United States

Location

Northwestern Medicine

Chicago, Illinois, 60611, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27101, United States

Location

Related Publications (1)

• Carter E, Johnson EE, Still M, Al-Assaf AS, Bryant A, Aluko P, Jeffery ST, Nambiar A. Single-incision sling operations for urinary incontinence in women. Cochrane Database Syst Rev. 2023 Oct 27;10(10):CD008709. doi: 10.1002/14651858.CD008709.pub4.

  PMID: 37888839 DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Stress; Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Catherine A Matthews, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2020
• First Posted: October 14, 2020
• Study Start: December 23, 2020
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2032
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)