Idiopathic Overactive Bladder With Urinary IncontinencePhase 1NCT03109379
Safety and Tolerability of TAR-302-5018 in Subjects With Idiopathic Overactive Bladder
A Phase 1 study testing Trospium-Releasing Intravesical System (TAR-302-5018) in people with Idiopathic Overactive Bladder With Urinary Incontinence, run by Taris Biomedical LLC at 12 sites in United States.
Trial summary
The purpose of this study is to determine if TAR-302-5018, an investigational drug-delivery system, is safe and tolerable in patients with idiopathic overactive bladder and urinary incontinence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Overactive Bladder With Urinary Incontinence
- What is being tested?
- Trospium-Releasing Intravesical System (TAR-302-5018)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 12 sitesUnited States
- Study dates
- 4 Apr 2017to 27 Sep 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptoms of overactive bladder (OAB) (frequency/urgency) with urge urinary incontinence or mixed urinary incontinence with a predominant urge component for at least 6 months
- 8 or more voids per 24 hours as recorded in a diary
- At least 4 incontinence episodes associated with urgency recorded in a 3-day diary.
- At least 1 episode must occur per each 24 hour day
- Inadequate response or limiting side effects with anticholinergics for the treatment of OAB
- Symptoms of idiopathic overactive bladder (iOAB) (frequency/urgency) with urge urinary incontinence or mixed urinary incontinence with a predominant urge component for at least 6 months.
Show all 10Show fewer
- 8 or more voids per 24 hours as recorded in a diary
- At least 4 incontinence episodes associated with urgency recorded in a 3-day diary.
- At least 1 episode must occur per each 24 hour day
- In the opinion of the investigator, the subject has experienced an inadequate response to or limiting side effects with prior oral medications for the treatment of OAB.
Who cannot join
- Age <18 years.
- OAB caused by neurological condition.
- Presence of significant renal dysfunction at screening (Glomerular Filtration Rate <30 mL/min).
- Presence of significant polyuria of any cause at screening (urine output >4,000 mL/day).
- History of pelvic radiation.
- History of either bladder cancer or bladder pathology that the investigator deems unfit for study inclusion.
Show all 67Show fewer
- Active malignancies within 12 months with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome.
- Subjects with any bladder or urethral anatomic feature that may prevent the safe placement, indwelling use, or removal of TAR 302 5018.
- In the opinion of the investigator, the subject has a history of significant stress urinary incontinence.
- Subjects with active bladder stones or history of bladder stones <6 months prior to study entry.
- History of recurrent symptomatic urinary tract infections (UTIs) (>4 per 1 year).
- Subjects with either urinary retention or gastric retention or uncontrolled narrow-angle glaucoma.
- A post-void residual volume (PVR) of 300 mL or greater
- Subjects with known hypersensitivity to trospium, chemically-related drugs, or component excipients.
- Subjects with known hypersensitivity to the device materials, including silicone and nitinol.
- Subjects actively taking oral trospium.
- The addition of a new or a change in dose to a current medication for the treatment of OAB (i.e. anticholinergics, beta-3 adrenergic agonists, antispasmodics, antidepressants, or hormones) within 30 days prior to signing the informed consent form (ICF). A stable dose must continue through the final study visit. If previously used and discontinued, these medications must have been stopped for >2 weeks prior to Day 0.
- Intravesical onabotulinum toxin use within the last 9 months prior to the Screening Visit.
- Intravesical anticholinergic medications within the last 30 days prior to the Screening Visit.
- History of non-medication based therapy (i.e. InterStim therapy) for the treatment of OAB. History of non-invasive neuromodulation (i.e. Percutaneous Tibial Nerve Stimulation (PTNS)) is allowed if discontinued at least 8 weeks prior to Study Day 0.
- Female subject who is pregnant (as verified by urine test at time of screening) or lactating or of childbearing potential and not using acceptable methods of contraception.
- Subject has a medical condition that may cause noncompliance with the study protocol.
- Subject refuses to provide written informed consent.
- Subject will be unable or unwilling to complete the questionnaires, diaries, or attend all protocol mandated study visits.
- Participation in another drug, device, or behavioral study within 60 days prior to the Screening Visit.
- History or presence of any significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, gynecological, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder that, in the opinion of the investigator, contraindicates participation.
- History of any of the following within 3 months prior to Screening Visit:
- Major illness/major surgery (requiring hospitalization), including pelvic, lower back surgery or procedure unrelated to bladder cancer; most outpatient procedures are not exclusionary
- Renal or ureteral stone disease or instrumentation
- Childbirth
- Difficulty providing blood samples.
- Other unspecified reasons that, in the opinion of the investigator or TARIS, make the subject unsuitable for enrollment.
- Age <18 years.
- Neurologic bladder condition.
- Subjects with Diabetes Mellitus (both Type 1 \& Type 2) must demonstrate optimal glycemic control with HbA1c levels < 7.5 % and an absence of significant glucosuria defined as 3+ glucose via dipstick at screening.
- Presence of significant polyuria of any cause at screening (urine output >3,000 mL/day).
- Presence of nocturnal polyuria at time of study screening defined as >30% of total 24-hour urine collected from time of evening (P.M.) sleep and inclusive of the first morning (A.M.) void.
- History of pelvic irradiation.
- History of either bladder cancer or bladder pathology that the investigator deems unfit for study inclusion.
- Currently uses intermittent catheterization (IC) to empty the bladder within 30 days of Day 0.
- Subjects with any bladder or urethral anatomic feature (e.g., urethral stricture) that in the opinion of the investigator may prevent the safe placement, indwelling use, or removal of IP.
- Subjects with active bladder stones or history of bladder stones < 6 months prior to study entry.
- Gross hematuria within 30 days of Day 0.
- History of uncontrolled bleeding, bleeding diathesis, or underlying coagulopathy within 30 days of Day 0.
- In the opinion of the investigator, the subject has a history of predominance of significant stress urinary incontinence.
- History of > 2 symptomatic urinary tract infections in the 6-months prior to Day 0.
- Subjects with either urinary retention or gastric retention or uncontrolled narrow-angle glaucoma within 90 days of Day 0.
- A post-void residual volume (PVR) of 100-mL or greater.
- Subjects with known hypersensitivity to trospium, chemically-related drugs, or component excipients.
- Subjects with known hypersensitivity to the device materials, including silicone and nitinol.
- Anticholinergic or beta-3 agonist use for the treatment of urge urinary incontinence < 2 weeks prior to Day 0.
- History of intravesical onabotulinum toxin use within the last 9 months prior to the Screening Visit.
- Intravesical anticholinergic medications within the last 14 days prior to the Screening Visit.
- History of procedural-based neuromodulation therapy (e.g. InterStim therapy, Percutaneous Tibial Nerve Stimulation [PTNS]) for the treatment of OAB.
- Female subject who is pregnant (as verified by serum test at time of screening) or lactating.
- Subject has, in the opinion of the investigator, a medical condition that may cause noncompliance with the study protocol.
- Subject who is unable or unwilling to complete the questionnaires, diaries, or attend all protocol mandated study visits.
- Participation in another drug, device, or behavioral study within 60 days prior to the Screening Visit.
- History or presence of any significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, gynecological, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder, or other unspecified reasons that, in the opinion of the investigator or TARIS, make the subject unsuitable for enrollment.
- History of any of the following within 3 months prior to Screening Visit:
- Major illness/major surgery (requiring hospitalization), including pelvic, lower back surgery or procedure; most outpatient procedures are not exclusionary.
- Childbirth.
- History of prostatic biopsy or surgery (ablative or non-ablative) within 6 months prior to Day 0.
- History of significant pelvic organ prolapse (Grade >/= 3).
- Difficulty providing blood samples.
- Known history of drug or alcohol dependency within 12 months of screening.
- Other unspecified reasons that, in the opinion of the investigator or TARIS, make the subject unsuitable for enrollment.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Accumed Research
Garden City, New York, 11530-1664
DelRicht Clinical Research, LLC
New Orleans, Louisiana, 70115
Manhattan Medical Resear
New York, New York, 10016
Clinical Research Center of Florida
Pompano Beach, Florida, 33060
William Beaumont Hospital - Royal Oak
Royal Oak, Michigan, 48073
Medical Center for Clinical Research
San Diego, California, 92108
Michigan Institute of Urology
Troy, Michigan, 48084
Urological Associates of Southern Arizona
Tucson, Arizona, 85715
Urology of Virginia
Virginia Beach, Virginia, 23462
New Jersey Urology
Voorhees Township, New Jersey, 08043
Bay State Clinical Trials, Inc
Watertown, Massachusetts, 02472
UWCR - Lyndhurst Gynecologic Associates
Winston-Salem, North Carolina, 27103
About this study
Official title: A Prospective, Multi-center, Open-label Study of Trospium Delivered Intravesically by TAR-302-5018 to Subjects With Idiopathic Overactive Bladder (iOAB) and Urinary Incontinence
The purpose of this study is to determine if TAR-302-5018, an investigational drug-delivery system, is safe and tolerable in patients with idiopathic overactive bladder and urinary incontinence.
- Being tested
- Trospium-Releasing Intravesical System (TAR-302-5018)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trospium-Releasing Intravesical System (TAR-302-5018)Drug
TAR-302-5018 is a passive, nonresorbable trospium-releasing intravesical system whose primary mode of action is the controlled release of trospium into the bladder over a 42-day period.
| Study group | Role | What they receive |
|---|---|---|
| TAR-302-5018 (42-day Indwelling) | Experimental | Trospium-Releasing Intravesical System (TAR-302-5018) is placed into the bladder through an inserter on Study Day 0 and is removed on Study Day 42. TAR-302-5018 releases trospium gradually during the 42 day indwelling time. Receives: Drug: Trospium-Releasing Intravesical System (TAR-302-5018) |
| TAR-302-5018 (84-day Indwelling) | Experimental | Trospium-Releasing Intravesical System (TAR-302-5018) is placed into the bladder through an inserter on Study Day 0 and is removed on Study Day 84. TAR-302-5018 releases trospium gradually during the 84 day indwelling time. Receives: Drug: Trospium-Releasing Intravesical System (TAR-302-5018) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of TAR-302-5018 assessed throughout the study based on reported AEs (Part 1)
Safety will be assessed throughout the study based on reported AEs, investigational product events (IPEs), physical examinations (PEs), vital signs, clinical laboratory tests, scheduled cystoscopic examinations, bladder ultrasounds, bladder post-void residual volume (PVR), and the use of concomitant medications.
Measured: Upon insertion, 42-day continuous exposure, and removal
Safety of TAR-302-5018 assessed throughout the study based on reported AEs (Part 2)
Safety will be assessed throughout the study based on reported AEs, investigational product events (IPEs), physical examinations (PEs), vital signs, clinical laboratory tests, scheduled cystoscopic examinations, bladder ultrasounds, bladder post-void residual volume (PVR), and the use of concomitant medications.
Measured: Upon insertion, 84-day continuous exposure, and removal
Secondary outcomes (10)
Tolerability of TAR-302-5018 (Part 1)
Percent of subjects who are tolerant of TAR-302-5018 indwelling for the designated period of time and do not require TAR-302-5018 removal prior to the scheduled date of removal due to meeting any of the Subject Stopping Criteria or other drug or device constituent related adverse event.
Measured: Upon insertion, 42-day continuous exposure, and removal
Tolerability of TAR-302-5018 (Part 2)
Percent of subjects who are tolerant of TAR-302-5018 indwelling for the designated period of time and do not require TAR-302-5018 removal prior to the scheduled date of removal due to meeting any of the Subject Stopping Criteria or other drug or device constituent related adverse event.
Measured: Upon insertion, 84-day continuous exposure, and removal
Pharmacokinetic Analysis of Plasma and Urine (Part 1)
Analysis of plasma trospium exposure and urinary trospium exposure.
Measured: From Day 0 to Day 56
Pharmacokinetic Analysis of Plasma and Urine (Part 2)
Analysis of plasma trospium exposure and urinary trospium exposure.
Measured: From Day 0 to Day 112
Reduction in incontinence over baseline (Part 1)
A negative change from baseline in number of daily episodes of urinary incontinence, where incontinence is defined as an incident of involuntary loss of urine.
Measured: From Day 0 to Day 84
Reduction in incontinence over baseline (Part 2)
A negative change from baseline in number of daily episodes of urinary incontinence, where incontinence is defined as an incident of involuntary loss of urine.
Measured: From Day 0 to Day 112
Reduction in daily micturition episodes (Part 1)
A negative change from baseline in the number of times a subject urinates into the toilet.
Measured: From Day 0 to Day 56
Reduction in daily micturition episodes (Part 2)
A negative change from baseline in the number of times a subject urinates into the toilet.
Measured: From Day 0 to Day 112
Increase in voided volume per micturition (Part 1)
An increase over baseline as measured over separate 24-hour periods.
Measured: From Day 0 to Day 56
Increase in voided volume per micturition (Part 2)
An increase over baseline as measured over separate 24-hour periods.
Measured: From Day 0 to Day 112
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start4 Apr 2017
- Primary completion27 Sep 2019
- Study completion27 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Overactive Bladder With 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taris Biomedical LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christopher Cutie, MD, Study director, TARIS Biomedical, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03109379
- Sponsor's protocol ID
- TAR-302-103
- Status last verified
- Jan 2020
- First submitted
- 6 Apr 2017
- Last updated
- 13 Jan 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Open-label Study of Trospium Delivered Intravesically by TAR-302-5018 to Subjects With Idiopathic Overactive Bladder (iOAB) and Urinary Incontinence
- ClinicalTrials.gov ID
- NCT03109379
- Acronym / sponsor ID
- TAR-302-103
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Taris Biomedical LLCIndustry (pharma, biotech, devices)
- Study start
- 4 Apr 2017 (actual)
- Primary completion
- 27 Sep 2019 (actual)
- Study completion
- 27 Sep 2019 (actual)
- First posted
- 12 Apr 2017 (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.
The purpose of this study is to determine if TAR-302-5018, an investigational drug-delivery system, is safe and tolerable in patients with idiopathic overactive bladder and urinary incontinence.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAR-302-5018 (42-day Indwelling) | Experimental | Drug: Trospium-Releasing Intravesical System (TAR-302-5018)Trospium-Releasing Intravesical System (TAR-302-5018) is placed into the bladder through an inserter on Study Day 0 and is removed on Study Day 42. TAR-302-5018 releases trospium gradually during the 42 day indwelling time. |
| TAR-302-5018 (84-day Indwelling) | Experimental | Drug: Trospium-Releasing Intravesical System (TAR-302-5018)Trospium-Releasing Intravesical System (TAR-302-5018) is placed into the bladder through an inserter on Study Day 0 and is removed on Study Day 84. TAR-302-5018 releases trospium gradually during the 84 day indwelling time. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Symptoms of overactive bladder (OAB) (frequency/urgency) with urge urinary incontinence or mixed urinary incontinence with a predominant urge component for at least 6 months
- Inadequate response or limiting side effects with anticholinergics for the treatment of OAB
- Symptoms of idiopathic overactive bladder (iOAB) (frequency/urgency) with urge urinary incontinence or mixed urinary incontinence with a predominant urge component for at least 6 months.
- In the opinion of the investigator, the subject has experienced an inadequate response to or limiting side effects with prior oral medications for the treatment of OAB.
Key exclusion criteria (67 listed)
- Age <18 years.
- OAB caused by neurological condition.
- Presence of significant renal dysfunction at screening (Glomerular Filtration Rate <30 mL/min).
- Presence of significant polyuria of any cause at screening (urine output >4,000 mL/day).
- History of pelvic radiation.
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 |
|---|---|---|
| Trospium-Releasing Intravesical System (TAR-302-5018)TAR-302-5018 is a passive, nonresorbable trospium-releasing intravesical system whose primary mode of action is the controlled release of trospium into the bladder over a 42-day period. | Drug | TAR-302-5018 (42-day Indwelling), TAR-302-5018 (84-day Indwelling) |
Primary outcome
Safety of TAR-302-5018 assessed throughout the study based on reported AEs (Part 1)
Time frame: Upon insertion, 42-day continuous exposure, and removal
Safety will be assessed throughout the study based on reported AEs, investigational product events (IPEs), physical examinations (PEs), vital signs, clinical laboratory tests, scheduled cystoscopic examinations, bladder ultrasounds, bladder post-void residual volume (PVR), and the use of concomitant medications.
Safety of TAR-302-5018 assessed throughout the study based on reported AEs (Part 2)
Time frame: Upon insertion, 84-day continuous exposure, and removal
Safety will be assessed throughout the study based on reported AEs, investigational product events (IPEs), physical examinations (PEs), vital signs, clinical laboratory tests, scheduled cystoscopic examinations, bladder ultrasounds, bladder post-void residual volume (PVR), and the use of concomitant medications.
10 secondary outcomes
Tolerability of TAR-302-5018 (Part 1)
Time frame: Upon insertion, 42-day continuous exposure, and removal
Tolerability of TAR-302-5018 (Part 2)
Time frame: Upon insertion, 84-day continuous exposure, and removal
Pharmacokinetic Analysis of Plasma and Urine (Part 1)
Time frame: From Day 0 to Day 56
Pharmacokinetic Analysis of Plasma and Urine (Part 2)
Time frame: From Day 0 to Day 112
Reduction in incontinence over baseline (Part 1)
Time frame: From Day 0 to Day 84
Reduction in incontinence over baseline (Part 2)
Time frame: From Day 0 to Day 112
Reduction in daily micturition episodes (Part 1)
Time frame: From Day 0 to Day 56
Reduction in daily micturition episodes (Part 2)
Time frame: From Day 0 to Day 112
Increase in voided volume per micturition (Part 1)
Time frame: From Day 0 to Day 56
Increase in voided volume per micturition (Part 2)
Time frame: From Day 0 to Day 112
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
Related trials for Idiopathic Overactive Bladder With Urinary Incontinence
Recruiting
Comparison of the Efficacy of Perineal and Intravaginal Electrical Stimulation in Women With Idiopathic Overactive Bladder
Urinary Bladder, Overactive
Recruiting
Detrusor Nerve Radiofrequency Ablation for Overactive Bladder in Women
Overactive Bladder, Overactive Bladder (OAB)
Not yet recruiting
Transcutaneous Medial Plantar Nerve Stimulation in Women With Idiopathic Overactive Bladder
Urinary Bladder, Overactive
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. This study is not recruiting at the moment.
Christopher Cutie, MD study director
TARIS Biomedical, Inc.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Trospium-Releasing Intravesical System (TAR-302-5018) in people with Idiopathic Overactive Bladder With Urinary Incontinence, run by Taris Biomedical LLC at 12 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 10 inclusion and 67 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: finished, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of TAR-302-5018 assessed throughout the study based on reported AEs (Part 1) (time frame: Upon insertion, 42-day continuous exposure, and removal). 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 13 Jan 2020.