Single-incision Versus Retropubic Mid-Urethral Sling (Solyx) for SUI During Minimally Invasive Sacrocolpopexy
NCT ID: NCT04586166
Last Updated: 2025-04-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
180 participants
INTERVENTIONAL
2020-12-23
2032-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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RP Sling Group
Participants assigned to the retropubic (RP) sling group will have the RP sling placement procedure
RP Sling
Participants assigned to the retropubic (RP) sling group will have the RP sling placement procedure.
SIS Group
Participants assigned to the single-incision sling (SIS) group will have the SIS placement procedure
SIS
Participants assigned to the single-incision sling (SIS) group will have the SIS placement procedure.
Interventions
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RP Sling
Participants assigned to the retropubic (RP) sling group will have the RP sling placement procedure.
SIS
Participants assigned to the single-incision sling (SIS) group will have the SIS placement procedure.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
FEMALE
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Catherine A Matthews, MD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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Florida Robotic and Minimally Invasive Urogynecology
Coconut Creek, Florida, United States
Augusta University
Augusta, Georgia, United States
Northwestern Medicine
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Boston Urogynecology Associates
Cambridge, Massachusetts, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
Pelvic Floor Foundation of South Africa, University of Cape Town
Cape Town, , South Africa
Countries
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Central Contacts
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Catherine A Matthews, MD
Role: CONTACT
Facility Contacts
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Peter L Rosenblatt
Role: primary
Sachin N Vyas, MS,PhD
Role: primary
References
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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.
Other Identifiers
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IRB00068839
Identifier Type: -
Identifier Source: org_study_id
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