Urinary IncontinenceNASHA-DXNCT07850804
Trial of NASHA Dx Urethral Bulking System
A study testing NASHA Dx and Bulkamid in people with Urinary Incontinence and Urinary Incontinence (UI), run by Palette Life Sciences, Inc. at 5 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Incontinence, Urinary Incontinence (UI), Urinary Incontinence , Stress
- What is being tested?
- NASHA Dx and Bulkamid
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 314 participants
- Where
- 5 sitesUnited States
- Study dates
- Sep 2026to Sep 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Female, ≥ 18 years of age
- All women of childbearing potential must have a negative urine pregnancy test result documented prior to inclusion into the trial at Screening.
- 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
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- 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]
Who cannot join
- 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).
- 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
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- 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
- Systemic corticosteroids - currently taking, or has taken, within 3 months prior to the initial treatment visit
- 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
- Any unstable or severe cardio-vascular disease
- 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/dL will be excluded or HbA1c of 8% or greater will be excluded
- Active herpes genitalis (lesion, prodrome, symptoms)
- Currently participating in any other clinical trial or has participated in another clinical trial within 3 months prior to the screening/baseline visit, where the outcome measures may overlap.
- History of drug/alcohol abuse, mental dysfunction health condition, or other factors limiting her ability to cooperate fully
- 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)
- Not physically able to perform study procedures
- 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
- Post Void Residual (PVR) > 150 ml on at least 2 occasions
- Uncontrolled bleeding disorders
- Impassable urethral strictures
- Vaginal delivery or Cesarean section within 3 months prior to the screening/baseline visit
- Any other condition, which, in the opinion of the investigator, would make the subject not a suitable candidate for the study
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites
Regional Womens Health Group, LLC
Allentown, Pennsylvania, 18038
Primary Investigator, 610-730-2502, vincent.lucente@axiawh.com
Urology Partners of North Texas (UPNT) Research Institute
Arlington, Texas, 76017
Primary Investigator, 866-367-8768, tcannon-smith@upnt.com
Advocate Health National Center for Clinical Trial
Charlotte, North Carolina, 28204
Primary Investigator, 704-304-1160, michael.kennelly@advocatehealth.org
Nebraska Urology
Lincoln, Nebraska, 68516
Primary Investigator, 402-489-8888, tkirkpatrick@ne-urology.com
Prestige Medical Group
Tustin, California, 92780
Primary Investigator, 949-291-1824, drgabal@drgabal.com
About this study
Official title: Trial of NASHA Dx Urethral Bulking System to Treat Stress Urinary Incontinence and Stress Predominant Mixed Urinary Incontinence
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).
Read the detailed description
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).
After 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.
- Conditions
- Urinary Incontinence, Urinary Incontinence (UI), Urinary Incontinence , Stress, Urinary Incontinence Due to Urethral Sphincter Incompetence, Urethral Sphincter Activity, Intrinsic Sphincter Deficiency
- Being tested
- NASHA Dx, Bulkamid
- Keywords
- Urethral Bulking Agents
- Medical subject headings
- Urinary Incontinence, Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NASHA DxDevice
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.
BulkamidDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| NASHA Dx | Experimental | Investigational device Receives: Device: NASHA Dx |
| Bulkamid | Active comparator | Control device Receives: Device: Bulkamid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Primary Safety Endpoint
The incidence of all adverse events (AEs) through the 12-month follow-up visit after the final injection.
Measured: 12 months
Secondary outcomes (7)
Proportion of subjects with at least a 50% reduction from baseline in daily number of incontinence episodes
Documented via bladder diary
Measured: 12 months
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/frequency), stress (activity related leakage), and obstructive/discomfort (voiding difficulties and pain).
Measured: 12 months
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.
Measured: 12 months
Patient Global Impressions Improvement (PGI-I) responder rate
Based on the subject perception of effectiveness ("somewhat improved," "much improved" or "very much improved")
Measured: 12 months
Proportion of subjects dry according to the 24-hr. pad test
i.e., ≤ 4g leakage
Measured: 12 months
Change from baseline in the average daily number of incontinence episodes
Based on bladder diary (stress, urgency, and all urinary incontinence episodes).
Measured: 12 months
Proportion of subjects with no SUI episodes
Based on bladder diary.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, controlled, single-blinded multicenter study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 314 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Palette Life Sciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07850804
- Sponsor's protocol ID
- 1022-002
- Acronym
- NASHA-DX
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Data sets of de-identified data underlying the results reported in the published article will be provided. Additionally, the protocol and consent documents will be available. These data will be available six months after publication. Data will be obtained from the corresponding author.