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
- Are there results?
- Not yet: the study is under way
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
Show all 12Show fewer
- 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
Show all 30Show fewer
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of NASHA Dx Urethral Bulking System to Treat Stress Urinary Incontinence and Stress Predominant Mixed Urinary Incontinence
- ClinicalTrials.gov ID
- NCT07850804
- Acronym / sponsor ID
- NASHA-DX / 1022-002
- Conditions
- Urinary Incontinence, Urinary Incontinence (UI), Urinary Incontinence , Stress, Urinary Incontinence Due to Urethral Sphincter Incompetence, Urethral Sphincter Activity, Intrinsic Sphincter Deficiency
- Keywords
- Urethral Bulking Agents
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 314 participants (estimated)
- Lead sponsor
- Palette Life Sciences, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 30 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Prospective, randomized, controlled, single-blinded multicenter study
| Arm | Type | Receives |
|---|---|---|
| NASHA Dx | Experimental | Device: NASHA DxInvestigational device |
| Bulkamid | Active comparator | Device: BulkamidControl device |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (30 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NASHA DxThe 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. | Device | NASHA Dx |
| BulkamidBulkamid 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. | Device | Bulkamid |
Primary outcome
Primary Effectiveness Endpoint
Time frame: 12 months
At least a 50% reduction from baseline to 12 months post-treatment in urine leakage, as documented by the 24-hour pad weight test.
Primary Safety Endpoint
Time frame: 12 months
The incidence of all adverse events (AEs) through the 12-month follow-up visit after the final injection.
7 secondary outcomes
Proportion of subjects with at least a 50% reduction from baseline in daily number of incontinence episodes
Time frame: 12 months
Change from baseline in Urogenital Distress Inventory-Short Form (UDI-6) score
Time frame: 12 months
Change from baseline in Incontinence Impact Questionnaire, Short Form (UIQ-7) score
Time frame: 12 months
Patient Global Impressions Improvement (PGI-I) responder rate
Time frame: 12 months
Proportion of subjects dry according to the 24-hr. pad test
Time frame: 12 months
Change from baseline in the average daily number of incontinence episodes
Time frame: 12 months
Proportion of subjects with no SUI episodes
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cliff Kline (805-456-9653, cliff.kline@teleflex.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Effectiveness Endpoint (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.