Trial of NASHA Dx Urethral Bulking System

NCT07850804 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 1022-002
• Study Type: interventional
• Target: 314
• Locations: 1 country
• Sites: 5

Brief Summary

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).

Conditions

Urinary Incontinence; Urinary Incontinence (UI); Urinary Incontinence , Stress; Urinary Incontinence Due to Urethral Sphincter Incompetence; Urethral Sphincter Activity; Intrinsic Sphincter Deficiency; Pelvic Floor Dysfunction

Keywords

Urethral Bulking Agents

Outcome Measures

Primary Outcomes (2)

• 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

• Primary Safety Endpoint

  The incidence of all adverse events (AEs) through the 12-month follow-up visit after the final injection.

  12 months

Secondary Outcomes (7)

• Proportion of subjects with at least a 50% reduction from baseline in daily number of incontinence episodes

  12 months

• Change from baseline in Urogenital Distress Inventory-Short Form (UDI-6) score

  12 months

• Change from baseline in Incontinence Impact Questionnaire, Short Form (UIQ-7) score

  12 months

• Patient Global Impressions Improvement (PGI-I) responder rate

  12 months

• Proportion of subjects dry according to the 24-hr. pad test

  12 months

Study Arms (2)

NASHA Dx

EXPERIMENTAL

Investigational device

Device: NASHA Dx

Bulkamid

ACTIVE COMPARATOR

Control device

Device: Bulkamid

Interventions

NASHA Dx 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. NASHA Dx Injectable Gel is a sterile, injectable bulking agent composed of microspheres of cross-linked dextran ("dextranomer," 50 mg/ml) suspended in a carrier gel of non-animal, stabilized hyaluronic acid (NASHA, 17 mg/ml). The dextranomer microspheres range in diameter from 80 to 250 microns (average diameter approximately 130 microns). NASHA 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. The 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.

NASHA Dx

Bulkamid DEVICE

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/w) and water (97.5% w/w), 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. Bulkamid 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/precautions, known potential risks, and injection procedure. Bulkamid 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.

Bulkamid

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Female, ≥ 18 years of age
• SUI or stress predominant mixed urinary incontinence due to intrinsic sphincter deficiency (ISD) for at least 6 months
• Failed conservative therapy for stress urinary incontinence
• Documentation of at least 3 stress urinary incontinence episodes measured over 3 days
• Baseline 24-hr. pad weight test ≥ 5 g
• Intrinsic sphincter deficiency stress urinary incontinence defined as a urodynamic assessment in the past 6 months with Valsalva leak-point pressure (VLPP) \< 60 cm H2O and/or a maximal urethral closure pressure (MUCP) 20 cm H2O
• Clinical laboratory values such as white blood cell count, hemoglobin, AST/ALT, Creatinine, Bilirubin, blood glucose are within normal limits, or if abnormal, considered and documented as not clinically significant by the investigator
• Cleared for surgery by anesthesiologist preoperatively
• Life expectancy of more than 2 years
• Been informed of, and be able to perform, the study treatments and procedures, and signed an informed consent form.
• Provided authorization to use and disclose information for research purposes \[HIPAA (Health Insurance Portability and Accountability Act of 1996; US sites) or country-specific requirement\]

You may not qualify if:

• \. 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).
• Negative cough test or lack of leakage with valsalva maneuver on physical exam
• Historical Detrusor overactivity as determined by urodynamic assessment within the past year
• Significant urethral hypermobility (e.g. vaginal swab \> 30° from horizontal bladder neck)
• 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
• Patient may not have undergone a Mid-Urethral Sling (MUS), retropubic colpo or pubovaginal sling less than 6 months from screening
• Polyuria (≥ 3 L/24 hrs.)
• Three or more culture proven bacterial UTIs in the last 12 months or 2 culture proven bacterial UTIs in the last 6 months
• Current urogenital infection: urethritis, cystitis, urinary tract infection or vaginitis
• Unevaluated hematuria
• No prolapse through the introitus at screening visit
• Body mass index (BMI) \> 35 kg/m2
• Currently taking or has taken within 4 weeks prior to the screening/baseline visit, pharmacological treatment for Overactive Bladder (OAB) (including but not limited to anti-cholinergics or beta adrenergics)
• 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
• Active autoimmune diseases (e.g., connective tissue diseases) that could affect or confound treatment outcome

Sponsors & Collaborators

• Palette Life Sciences, Inc.: lead

Study Sites (5)

Prestige Medical Group

Tustin, California, 92780, United States

Location

Nebraska Urology

Lincoln, Nebraska, 68516, United States

Location

Advocate Health National Center for Clinical Trial

Charlotte, North Carolina, 28204, United States

Location

Regional Womens Health Group, LLC

Allentown, Pennsylvania, 18038, United States

Location

Urology Partners of North Texas (UPNT) Research Institute

Arlington, Texas, 76017, United States

Location

MeSH Terms

Conditions

Urinary Incontinence; Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Cliff Kline

CONTACT

805-456-9653; cliff.kline@teleflex.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: All subjects who sign a consent and meet inclusion and exclusion criteria will be randomized to the treatment or the control arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, randomized, controlled, single-blinded multicenter study

Study Record Dates

• First Submitted: September 23, 2026
• First Posted: September 30, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: IPD and supporting data will be available starting 6 months after publication. The data will be available for 2 years.
• Access Criteria: Qualified academic or clinical investigators with valid scientific research proposal may have access to these data and can contact the corresponding author.

Locations

US (5)