Stress Urinary IncontinenceSASSNCT04586166
Single-incision Versus Retropubic Mid-Urethral Sling (Solyx) for SUI During Minimally Invasive Sacrocolpopexy
A study testing RP Sling and SIS in people with Stress Urinary Incontinence and Pelvic Floor Disorders, run by Wake Forest University Health Sciences at 5 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence, Pelvic Floor Disorders
- What is being tested?
- RP Sling and SIS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 5 sitesUnited States
- Study dates
- 23 Dec 2020to 31 Dec 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Augusta University
Augusta, Georgia, 30912
Northwestern Medicine
Chicago, Illinois, 60611
University of Chicago
Chicago, Illinois, 60637
Florida Robotic and Minimally Invasive Urogynecology
Coconut Creek, Florida, 33073
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27101
About this study
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
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.
Read the 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).
- Being tested
- RP Sling, SIS
- Keywords
- Retropubic Sling, Single-Incision Sling, Sacrocolpopexy
- Medical subject headings
- Urinary Incontinence, Stress, Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RP SlingDevice
Also called Advantage RP Sling
Participants assigned to the retropubic (RP) sling group will have the RP sling placement procedure.
SISDevice
Also called Solyx SIS System
Participants assigned to the single-incision sling (SIS) group will have the SIS placement procedure.
| Study group | Role | What they receive |
|---|---|---|
| RP Sling Group | Experimental | Participants assigned to the retropubic (RP) sling group will have the RP sling placement procedure Receives: Device: RP Sling |
| SIS Group | Experimental | Participants assigned to the single-incision sling (SIS) group will have the SIS placement procedure Receives: Device: SIS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 5 years after surgery
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 6 month up to 5 year post-surgery
Number of Participants needing bladder drainage
Requirement of urinary catheter due to incontinence or retention
Measured: 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.
Measured: Baseline, Surgery, Post Op: week 2, week 6, year 1, year 2, year 3, and year 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start23 Dec 2020
- Primary completion31 Dec 2031 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor
- Investigators
- Catherine A Matthews, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04586166
- Sponsor's protocol ID
- IRB00068839
- Acronym
- SASS
- Status last verified
- Mar 2026
- First submitted
- 7 Oct 2020
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Only limited dataset without PHI will be shared with the study bio statistical group.
Publications
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.
PubMed 37888839
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04586166
- Acronym / sponsor ID
- SASS / IRB00068839
- Keywords
- Retropubic Sling, Single-Incision Sling, Sacrocolpopexy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- 23 Dec 2020 (actual)
- Primary completion
- 31 Dec 2031 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 14 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RP Sling Group | Experimental | Device: RP SlingParticipants assigned to the retropubic (RP) sling group will have the RP sling placement procedure |
| SIS Group | Experimental | Device: SISParticipants assigned to the single-incision sling (SIS) group will have the SIS placement procedure |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RP SlingAlso: Advantage RP SlingParticipants assigned to the retropubic (RP) sling group will have the RP sling placement procedure. | Device | RP Sling Group |
| SISAlso: Solyx SIS SystemParticipants assigned to the single-incision sling (SIS) group will have the SIS placement procedure. | Device | SIS Group |
Primary outcome
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
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
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
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
8 secondary outcomes
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
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
Pelvic Floor Impact (PFIQ-SF7)
Time frame: Baseline, Surgery, Post Op: week 2, week 6, year 1, year 2, year 3, and year 5
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
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
Number of Participants needing Retreatment
Time frame: 6 month up to 5 year post-surgery
Number of Participants needing bladder drainage
Time frame: beyond 6 weeks post-surgery
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Derived from this study: PubMed 37888839Carter 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.
- Individual participant dataSharing planned: No. Only limited dataset without PHI will be shared with the study bio statistical group.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine A Matthews, MD principal investigator
Wake Forest University Health Sciences
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RP Sling and SIS in people with Stress Urinary Incontinence and Pelvic Floor Disorders, run by Wake Forest University Health Sciences at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with subjectively bothersome stress incontinence (time frame: 6 weeks after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04586166, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.