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| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RP Sling Group | Experimental | Participants assigned to the retropubic (RP) sling group will have the RP sling placement procedure |
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| SIS Group | Experimental | Participants assigned to the single-incision sling (SIS) group will have the SIS placement procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RP Sling | Device | Participants assigned to the retropubic (RP) sling group will have the RP sling placement procedure. |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
Female patients with pelvic organ prolapse.
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| Name | Affiliation | Role |
|---|---|---|
| Catherine A Matthews, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida Robotic and Minimally Invasive Urogynecology | Coconut Creek | Florida | 33073 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37888839 | Derived | 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. |
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Only limited dataset without PHI will be shared with the study bio statistical group.
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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.
| SIS | Device | Participants assigned to the single-incision sling (SIS) group will have the SIS placement procedure. |
|
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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 |
| Augusta University |
| Augusta |
| Georgia |
| 30912 |
| United States |
| Northwestern Medicine | Chicago | Illinois | 60611 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | 27101 | United States |
| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| D059952 | Pelvic Floor Disorders |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011248 | Pregnancy Complications |
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