Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2026-01-02 @ 2:51 AM
Study NCT ID:
NCT04586166
Status:
RECRUITING
Last Update Posted:
2025-04-29
First Post:
2020-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single-incision Versus Retropubic Mid-Urethral Sling (Solyx) for SUI During Minimally Invasive Sacrocolpopexy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014550', 'term': 'Urinary Incontinence, Stress'}, {'id': 'D059952', 'term': 'Pelvic Floor Disorders'}], 'ancestors': [{'id': 'D014549', 'term': 'Urinary Incontinence'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': '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.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-12-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2032-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-24', 'studyFirstSubmitDate': '2020-10-07', 'studyFirstSubmitQcDate': '2020-10-13', 'lastUpdatePostDateStruct': {'date': '2025-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2031-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with subjectively bothersome stress incontinence', 'timeFrame': '6 weeks after surgery', 'description': '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'}, {'measure': 'Number of participants with subjectively bothersome stress incontinence', 'timeFrame': '1 year after surgery', 'description': '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'}, {'measure': 'Number of participants with subjectively bothersome stress incontinence', 'timeFrame': '3 years after surgery', 'description': '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'}, {'measure': 'Number of participants with subjectively bothersome stress incontinence', 'timeFrame': '5 years after surgery', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'VAS (Visual Analogue Scale Surgeon ease of Use)', 'timeFrame': 'Baseline, Surgery, Post Op: week 2, week 6, year 1, year 2, year 3, and year 5', 'description': 'This will be assessed using the numeric rating scale (NRS). The score is 0-10, with higher scores denoting a greater degree of satisfaction.'}, {'measure': 'Pelvic Organ Prolapse/Urinary Incontinence Sexual Functioning Short Form (PISQ-IR)', 'timeFrame': 'Baseline, Surgery, Post Op: week 2, week 6, year 1, year 2, year 3, and year 5', 'description': '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.'}, {'measure': 'Pelvic Floor Impact (PFIQ-SF7)', 'timeFrame': 'Baseline, Surgery, Post Op: week 2, week 6, year 1, year 2, year 3, and year 5', 'description': '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'}, {'measure': 'Patient Global Impression of Improvement (PGI-I)', 'timeFrame': 'Baseline, Surgery, Post Op: week 2, week 6, year 1, year 2, year 3, and year 5', 'description': "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"}, {'measure': 'Assessment of post-void residual (PVR) volume', 'timeFrame': 'Baseline, Surgery, Post Op: week 2, week 6, year 1, year 2, year 3, and year 5', 'description': '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'}, {'measure': 'Number of Participants needing Retreatment', 'timeFrame': '6 month up to 5 year post-surgery', 'description': 'Surgical intervention for urinary retention (sling lysis) at any time point after surgery'}, {'measure': 'Number of Participants needing bladder drainage', 'timeFrame': 'beyond 6 weeks post-surgery', 'description': 'Requirement of urinary catheter due to incontinence or retention'}, {'measure': 'Pelvic Floor Distress Inventory (PFDI-SF20)', 'timeFrame': 'Baseline, Surgery, Post Op: week 2, week 6, year 1, year 2, year 3, and year 5', 'description': '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.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Retropubic Sling', 'Single-Incision Sling', 'Sacrocolpopexy'], 'conditions': ['Stress Urinary Incontinence', 'Pelvic Floor Disorders']}, 'referencesModule': {'references': [{'pmid': '37888839', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'genderBased': True, 'genderDescription': 'Female patients with pelvic organ prolapse.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 21 years of age\n* Vaginal bulge symptoms as indicated by an affirmative response of \\>1 to question 3 of the PFDI-SF20\n* POP ≥ stage II according to the pelvic organ prolapse quantification (POP-Q) system45, with evidence of apical descent\n* Women being considered for minimally invasive sacrocolpopexy (with or without concomitant hysterectomy)\n* Objective SUI: positive standardized cough stress test on clinical examination or on urodynamic study with reduced prolapse\n* Understanding and acceptance of the need to return for all scheduled follow-up visits and willing to complete study questionnaires\n* Able to give informed consent\n\nExclusion Criteria:\n\n* Prior surgery for stress urinary incontinence including mid-urethral sling; Burch/MMK; fascial pubovaginal sling (autologous, xenograft or allograft); and urethral bulking injection\n* Any serious disease, or chronic condition, that could interfere with the study compliance\n* Unwilling to have a synthetic sling\n* Untreated and unresolved urinary tract infection\n* Poorly-controlled diabetes mellitus (HgbA1c \\> 9 within 3 months of surgery date)\n* Neurogenic bladder/ pre-operative self-catheterization\n* Elevated post-void residual/PVR (\\>150 ml) that does not resolve with prolapse reduction testing (pessary, prolapse reduced uroflow or micturition study)\n* Prior pelvic radiation\n* Inflammatory bowel disease\n* Current genitourinary fistula or urethral diverticulum\n* Planned concomitant bowel related surgery including sphincteroplasty and perineal rectal prolapse surgery, rectovaginal fistula repair, hemorrhoidectomy\n* Pregnant or Planning to Conceive\n* Incarcerated'}, 'identificationModule': {'nctId': 'NCT04586166', 'acronym': 'SASS', 'briefTitle': 'Single-incision Versus Retropubic Mid-Urethral Sling (Solyx) for SUI During Minimally Invasive Sacrocolpopexy', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'SASS: Randomized Trial of Single-incision Versus Retropubic Mid-Urethral Sling (Solyx) for Concomitant Management of Stress Urinary Incontinence During Minimally Invasive Sacrocolpopexy', 'orgStudyIdInfo': {'id': 'IRB00068839'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RP Sling Group', 'description': 'Participants assigned to the retropubic (RP) sling group will have the RP sling placement procedure', 'interventionNames': ['Device: RP Sling']}, {'type': 'EXPERIMENTAL', 'label': 'SIS Group', 'description': 'Participants assigned to the single-incision sling (SIS) group will have the SIS placement procedure', 'interventionNames': ['Device: SIS']}], 'interventions': [{'name': 'RP Sling', 'type': 'DEVICE', 'otherNames': ['Advantage RP Sling'], 'description': 'Participants assigned to the retropubic (RP) sling group will have the RP sling placement procedure.', 'armGroupLabels': ['RP Sling Group']}, {'name': 'SIS', 'type': 'DEVICE', 'otherNames': ['Solyx SIS System'], 'description': 'Participants assigned to the single-incision sling (SIS) group will have the SIS placement procedure.', 'armGroupLabels': ['SIS Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33073', 'city': 'Coconut Creek', 'state': 'Florida', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Florida Robotic and Minimally Invasive Urogynecology', 'geoPoint': {'lat': 26.25175, 'lon': -80.17894}}, {'zip': '30912', 'city': 'Augusta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Torri Blackmon', 'role': 'CONTACT', 'email': 'TBlackm2@augusta.edu', 'phone': '706-721-1088'}, {'name': 'Jennifer Lanzer, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Augusta University', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Northwestern Medicine', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kimberly Kenton, MD', 'role': 'CONTACT', 'email': 'Kimberly.Kenton@bsd.uchicago.edu'}], 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '02138', 'city': 'Cambridge', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Peter L Rosenblatt', 'role': 'CONTACT', 'phone': '617-354-5452'}, {'name': 'Peter L Rosenblatt, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Boston Urogynecology Associates', 'geoPoint': {'lat': 42.3751, 'lon': -71.10561}}, {'zip': '27101', 'city': 'Winston-Salem', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sachin N Vyas, MS,PhD', 'role': 'CONTACT', 'phone': '336-713-4098'}, {'name': 'Catherine A Matthews, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Wake Forest Baptist Medical Center', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '8001', 'city': 'Cape Town', 'status': 'SUSPENDED', 'country': 'South Africa', 'facility': 'Pelvic Floor Foundation of South Africa, University of Cape Town', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}], 'centralContacts': [{'name': 'Sachin N Vyas, MS,PhD', 'role': 'CONTACT', 'email': 'svyas@wakehealth.edu', 'phone': '336-713-4098'}, {'name': 'Catherine A Matthews, MD', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Catherine A Matthews, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Only limited dataset without PHI will be shared with the study bio statistical group.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}