[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658230":3},{"organization":4,"outcomesModule":7,"designInfo":39,"detailedDescription":49,"studyPopulation":38,"armGroups":50,"interventions":63,"overallOfficials":38,"centralContacts":71,"locations":77,"responsibleParty":152,"collaborators":38,"id":154,"slug":155,"hasResults":156,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":160,"eligibilityCriteria":161,"healthyVolunteers":156,"sex":162,"minAge":163,"maxAge":38,"enrollmentInfo":164,"targetDuration":38,"studyType":167,"phases":168,"briefSummary":170,"conditions":171,"keywords":179,"overallStatus":181,"whyStopped":38,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":191},{"fullName":5,"class":6},"Palette Life Sciences, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":38},[9,13],{"measure":10,"description":11,"timeFrame":12},"Primary Effectiveness Endpoint","At least a 50% reduction from baseline to 12 months post-treatment in urine leakage, as documented by the 24-hour pad weight test.","12 months",{"measure":14,"description":15,"timeFrame":12},"Primary Safety Endpoint","The incidence of all adverse events (AEs) through the 12-month follow-up visit after the final injection.",[17,20,23,26,29,32,35],{"measure":18,"description":19,"timeFrame":12},"Proportion of subjects with at least a 50% reduction from baseline in daily number of incontinence episodes","Documented via bladder diary",{"measure":21,"description":22,"timeFrame":12},"Change from baseline in Urogenital Distress Inventory-Short Form (UDI-6) score","UDI-6 is a validated 6 item questionnaire that evaluates three main symptom categories: irritative (urgency\u002Ffrequency), stress (activity related leakage), and obstructive\u002Fdiscomfort (voiding difficulties and pain).",{"measure":24,"description":25,"timeFrame":12},"Change from baseline in Incontinence Impact Questionnaire, Short Form (UIQ-7) score","UIQ-7 is medical assessment tool that measures how urinary incontinence affects quality of life and daily activities.",{"measure":27,"description":28,"timeFrame":12},"Patient Global Impressions Improvement (PGI-I) responder rate","Based on the subject perception of effectiveness (\"somewhat improved,\" \"much improved\" or \"very much improved\")",{"measure":30,"description":31,"timeFrame":12},"Proportion of subjects dry according to the 24-hr. pad test","i.e., ≤ 4g leakage",{"measure":33,"description":34,"timeFrame":12},"Change from baseline in the average daily number of incontinence episodes","Based on bladder diary (stress, urgency, and all urinary incontinence episodes).",{"measure":36,"description":37,"timeFrame":12},"Proportion of subjects with no SUI episodes","Based on bladder diary.",null,{"allocation":40,"interventionModel":41,"interventionModelDescription":42,"primaryPurpose":43,"observationalModel":38,"timePerspective":38,"maskingInfo":44},"RANDOMIZED","PARALLEL","Prospective, randomized, controlled, single-blinded multicenter study","TREATMENT",{"masking":45,"maskingDescription":46,"whoMasked":47},"SINGLE","All subjects who sign a consent and meet inclusion and exclusion criteria will be randomized to the treatment or the control arm.",[48],"PARTICIPANT","This is a prospective, randomized, single-blind study. The primary cohort for this study is adult women with mild, moderate and intrinsic sphincter deficiency (ISD) stress or stress urinary incontinence (SUI) or stress predominant mixed incontinence (MUI).\n\nAfter preliminary screening, subjects who sign an informed consent and are enrolled in the study will be randomized to the Investigational device (NASHA Dx) group or the Control device (Bulkamid) group. Subjects will not be told which treatment they will receive.",[51,57],{"label":52,"type":53,"description":54,"interventionNames":55},"NASHA Dx","EXPERIMENTAL","Investigational device",[56],"Device: NASHA Dx",{"label":58,"type":59,"description":60,"interventionNames":61},"Bulkamid","ACTIVE_COMPARATOR","Control device",[62],"Device: Bulkamid",[64,68],{"type":65,"name":52,"description":66,"armGroupLabels":67,"otherNames":38},"DEVICE","The NASHA Dx Urethral Bulking System comprises three components; NASHA Dx SUI Injectable Gel, the NASHA Dx SUI Needle and the Uro-BK Delivery Device.\n\nNASHA Dx Injectable Gel is a sterile, injectable bulking agent composed of microspheres of cross-linked dextran (\"dextranomer,\" 50 mg\u002Fml) suspended in a carrier gel of non-animal, stabilized hyaluronic acid (NASHA, 17 mg\u002Fml). The dextranomer microspheres range in diameter from 80 to 250 microns (average diameter approximately 130 microns).\n\nNASHA Dx Injectable Gel is provided in a pre-filled single use, 1 ml syringe. The syringe is equipped with a tip cap, plunger, and plunger rod. The syringe is terminally sterilized.\n\nThe injection needle to be used is the NASHA Dx SUI Needle, a 12cm, 23G extra-thin wall stainless steel cannula with markings at 1 cm and 2 cm from the tip, attached to a styrene-butadiene copolymer Luer-lock hub.",[52],{"type":65,"name":58,"description":69,"armGroupLabels":70,"otherNames":38},"Bulkamid Urethral Bulking System (i.e., \"Bulkamid\") is a permanently implanted, non-resorbable, injectable, transparent, hydrogel for urethral bulking. Bulkamid hydrogel consists of cross-linked polyacrylamide (2.5% w\u002Fw) and water (97.5% w\u002Fw), which is supplied sterile in 1 ml pre-filled syringes. It is intended to be injected with the sterile 23G x 12cm needle using a Bulkamid Rotatable Sheath.\n\nBulkamid is a commercially available device (P170023) indicated for urethral injection for the treatment of stress urinary incontinence (SUI) or stress predominant mixed urinary incontinence (MUI) due to intrinsic sphincter deficiency (ISD). Instructions for use provided by the manufacturer should be consulted for warnings\u002Fprecautions, known potential risks, and injection procedure.\n\nBulkamid was selected as the control device for this study because it is the market leader in injectable urethral bulking agents, and hence is the standard of care in the US.",[58],[72],{"name":73,"role":74,"phone":75,"phoneExt":38,"email":76},"Cliff Kline","CONTACT","805-456-9653","cliff.kline@teleflex.com",[78,96,110,124,138],{"facility":79,"status":38,"city":80,"state":81,"zip":82,"country":83,"countryCode":84,"cosmosGeoPoint":85,"geoPoint":90,"contacts":91},"Prestige Medical Group","Tustin","California","92780","United States","US",{"type":86,"coordinates":87},"Point",[88,89],-117.82617,33.74585,{"lat":89,"lon":88},[92],{"name":93,"role":74,"phone":94,"phoneExt":38,"email":95},"Primary Investigator","949-291-1824","drgabal@drgabal.com",{"facility":97,"status":38,"city":98,"state":99,"zip":100,"country":83,"countryCode":84,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"Nebraska Urology","Lincoln","Nebraska","68516",{"type":86,"coordinates":102},[103,104],-96.66696,40.8,{"lat":104,"lon":103},[107],{"name":93,"role":74,"phone":108,"phoneExt":38,"email":109},"402-489-8888","tkirkpatrick@ne-urology.com",{"facility":111,"status":38,"city":112,"state":113,"zip":114,"country":83,"countryCode":84,"cosmosGeoPoint":115,"geoPoint":119,"contacts":120},"Advocate Health National Center for Clinical Trial","Charlotte","North Carolina","28204",{"type":86,"coordinates":116},[117,118],-80.84313,35.22709,{"lat":118,"lon":117},[121],{"name":93,"role":74,"phone":122,"phoneExt":38,"email":123},"704-304-1160","michael.kennelly@advocatehealth.org",{"facility":125,"status":38,"city":126,"state":127,"zip":128,"country":83,"countryCode":84,"cosmosGeoPoint":129,"geoPoint":133,"contacts":134},"Regional Womens Health Group, LLC","Allentown","Pennsylvania","18038",{"type":86,"coordinates":130},[131,132],-75.49018,40.60843,{"lat":132,"lon":131},[135],{"name":93,"role":74,"phone":136,"phoneExt":38,"email":137},"610-730-2502","vincent.lucente@axiawh.com",{"facility":139,"status":38,"city":140,"state":141,"zip":142,"country":83,"countryCode":84,"cosmosGeoPoint":143,"geoPoint":147,"contacts":148},"Urology Partners of North Texas (UPNT) Research Institute","Arlington","Texas","76017",{"type":86,"coordinates":144},[145,146],-97.10807,32.73569,{"lat":146,"lon":145},[149],{"name":93,"role":74,"phone":150,"phoneExt":38,"email":151},"866-367-8768","tcannon-smith@upnt.com",{"type":153,"investigatorFullName":38,"investigatorTitle":38,"investigatorAffiliation":38,"oldNameTitle":38,"oldOrganization":38},"SPONSOR","100658230","trial-of-nasha-dx-urethral-bulking-system-100658230",false,"NCT07850804","Trial of NASHA Dx Urethral Bulking System","Trial of NASHA Dx Urethral Bulking System to Treat Stress Urinary Incontinence and Stress Predominant Mixed Urinary Incontinence","NASHA-DX","Inclusion Criteria:\n\n1. 1\\. Female, ≥ 18 years of age\n2. All women of childbearing potential must have a negative urine pregnancy test result documented prior to inclusion into the trial at Screening.\n3. SUI or stress predominant mixed urinary incontinence due to intrinsic sphincter deficiency (ISD) for at least 6 months\n4. Failed conservative therapy for stress urinary incontinence\n5. Documentation of at least 3 stress urinary incontinence episodes measured over 3 days\n6. Baseline 24-hr. pad weight test ≥ 5 g\n7. Intrinsic sphincter deficiency stress urinary incontinence defined as a urodynamic assessment in the past 6 months with Valsalva leak-point pressure (VLPP) \\\u003C 60 cm H2O and\u002For a maximal urethral closure pressure (MUCP) 20 cm H2O\n8. Clinical laboratory values such as white blood cell count, hemoglobin, AST\u002FALT, Creatinine, Bilirubin, blood glucose are within normal limits, or if abnormal, considered and documented as not clinically significant by the investigator\n9. Cleared for surgery by anesthesiologist preoperatively\n10. Life expectancy of more than 2 years\n11. Been informed of, and be able to perform, the study treatments and procedures, and signed an informed consent form.\n12. Provided authorization to use and disclose information for research purposes \\[HIPAA (Health Insurance Portability and Accountability Act of 1996; US sites) or country-specific requirement\\]\n\nExclusion Criteria:\n\n1. 1\\. Urgency Predominant Mixed urinary incontinence, confirmed by 3-day bladder diary. (greater than 50% of incontinence episodes due to urge or less than 50% of incontinence episodes due to stress).\n2. Negative cough test or lack of leakage with valsalva maneuver on physical exam\n3. Historical Detrusor overactivity as determined by urodynamic assessment within the past year\n4. Significant urethral hypermobility (e.g. vaginal swab \\> 30° from horizontal bladder neck)\n5. History of urethral bulking, artificial urinary sphincters and previous urethral surgery for incontinence or non-incontinence related indications (eg. fistulas or diverticula) are not permitted\n6. Patient may not have undergone a Mid-Urethral Sling (MUS), retropubic colpo or pubovaginal sling less than 6 months from screening\n7. Polyuria (≥ 3 L\u002F24 hrs.)\n8. Three or more culture proven bacterial UTIs in the last 12 months or 2 culture proven bacterial UTIs in the last 6 months\n9. Current urogenital infection: urethritis, cystitis, urinary tract infection or vaginitis\n10. Unevaluated hematuria\n11. No prolapse through the introitus at screening visit\n12. Body mass index (BMI) \\> 35 kg\u002Fm2\n13. Currently taking or has taken within 4 weeks prior to the screening\u002Fbaseline visit, pharmacological treatment for Overactive Bladder (OAB) (including but not limited to anti-cholinergics or beta adrenergics)\n14. Allergy to hyaluronic acid-based products or dextran or history of severe allergies or anaphylaxis including hypersensitivity to local anesthetics such as lidocaine or antibiotics used for treating urinary tract infections\n15. Active autoimmune diseases (e.g., connective tissue diseases) that could affect or confound treatment outcome\n16. Systemic corticosteroids - currently taking, or has taken, within 3 months prior to the initial treatment visit\n17. Currently has cancer or has a history of cancer within the past 5 years. Subjects with a history of skin cancer with no evidence of skin malignancy for less than 2 years, will be excluded. Note: basal cell carcinoma is not an exclusion criterion\n18. Any unstable or severe cardio-vascular disease\n19. Uncontrolled diabetes defined as HbA1c greater than 8% within the prior 6 months or at screening. Note: Patients with suspected or known diabetes mellitus type II who lack an HbA1c result within the past 6 months will have a random glucose test at screening and a HbA1c test at screening. Patients with blood glucose \\>180 mg\u002FdL will be excluded or HbA1c of 8% or greater will be excluded\n20. Active herpes genitalis (lesion, prodrome, symptoms)\n21. Currently participating in any other clinical trial or has participated in another clinical trial within 3 months prior to the screening\u002Fbaseline visit, where the outcome measures may overlap.\n22. History of drug\u002Falcohol abuse, mental dysfunction health condition, or other factors limiting her ability to cooperate fully\n23. Pregnant, lactating, or not practicing adequate contraception (refer to inclusion criteria), was intending to become pregnant, or to lactate for the duration of this study (approximately 12 months)\n24. Not physically able to perform study procedures\n25. Bladder dysfunction in the setting of known neurologic disease that negatively impacts bladder function (including but not limited to stroke, multiple sclerosis, and Parkinson's disease) or known neurologic pathology that in the opinion of the investigator contributes to bladder dysfunction\n26. Post Void Residual (PVR) \\> 150 ml on at least 2 occasions\n27. Uncontrolled bleeding disorders\n28. Impassable urethral strictures\n29. Vaginal delivery or Cesarean section within 3 months prior to the screening\u002Fbaseline visit\n30. Any other condition, which, in the opinion of the investigator, would make the subject not a suitable candidate for the study","FEMALE","18 Years",{"count":165,"type":166},314,"ESTIMATED","INTERVENTIONAL",[169],"NA","Prospective, randomized, single-blind study to evaluate the safety and efficacy of NASHA Dx investigational device compared to controlled device Bulkamid in adult women with mild, moderate and intrinsic sphincter deficiency (ISD).",[172,173,174,175,176,177,178],"Urinary Incontinence","Urinary Incontinence (UI)","Urinary Incontinence , Stress","Urinary Incontinence Due to Urethral Sphincter Incompetence","Urethral Sphincter Activity","Intrinsic Sphincter Deficiency","Pelvic Floor Dysfunction",[180],"Urethral Bulking Agents","NOT_YET_RECRUITING","2026-09-23",{"date":184,"type":185},"2026-09-30","ACTUAL",{"date":187,"type":166},"2026-09",{"date":189,"type":166},"2028-09",{"name":5,"class":6},5]