Overactive Bladder (OAB)Phase 2NCT07391878
Evaluate the Safety and Efficacy of TRG-200 KIT in Patients With Refractory Overactive Bladder.
A Phase 2 study testing TRG-200 KIT in people with Overactive Bladder (OAB), run by Trigone Pharma Ltd. at 1 site in Israel.
Trial summary
This is an open-label, single-center pilot study designed to evaluate the safety, tolerability, and preliminary efficacy of TRG-200 KIT, an intravesical sustained-release oxybutynin formulation, in adult patients with refractory overactive bladder (OAB). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overactive Bladder (OAB)
- What is being tested?
- TRG-200 KIT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- 15 Feb 2026to 15 Dec 2027
- Phase
- Phase 2
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to provide written informed consent and comply with all study procedures.
- Male or female adults aged 18 years or older.
- Documented diagnosis of overactive bladder (OAB) for more than 6 months, refractory or intolerant to oral anticholinergic or other OAB therapies.
- OAB is defined as urinary urgency, usually accompanied by frequency and/or nocturia, with or without urgency urinary incontinence.
- Ability to perform and tolerate urethral catheterization for intravesical instillation.
- Meets the following criteria based on the 3-day voiding diary completed at both the Run-in and Baseline visits:
Show all 15Show fewer
- Average of ≥8 micturitions per day, and
- Average of ≥3 urgency episodes per day, and
- Average of ≥2 nocturia episodes per night.
- Participants who report significant improvement during the Run-in phase may continue in the study, provided they meet all inclusion criteria, following consultation with the investigator and based on their self-reported assessment.
- Post-void residual (PVR) urine volume <150 mL.
- Negative urine culture at screening.
- Women of childbearing potential must have a negative serum pregnancy test at screening and agree to use effective contraception throughout the study.
- Stable medical condition, without acute illness, as determined by the investigator.
- Demonstrated ability to complete the 3-day voiding diary as reviewed at the Run-in and Baseline visits.
Who cannot join
- Pregnant or breastfeeding women, or women of childbearing potential not using acceptable contraception.
- Known contraindication, hypersensitivity, or allergy to oxybutynin or other anticholinergic agents.
- History of 24-hour urine volume >3,000 mL.
- Active urinary tract infection or genitourinary infection at screening (re-screening allowed once after treatment).
- Lower urinary tract pathology that may account for symptoms, including but not limited to:
- urethral diverticulum, radiation cystitis, tuberculosis cystitis, neurogenic bladder, vaginal candidiasis, urolithiasis, interstitial cystitis, urothelial tumor, clinically significant benign prostatic hyperplasia with obstruction, bladder outlet obstruction, prostatitis, prostate or gastrointestinal cancer.
Show all 26Show fewer
- Structural abnormalities of the bladder (e.g., diverticula, stones) or urogenital anatomical defects.
- History of bladder tumors or prostate cancer within the past 5 years, or history of non-muscle invasive bladder cancer (low-grade) within the past 5 years.
- Ongoing or planned treatment for urologic or gynecologic malignancy.
- Requirement for indwelling catheter or clean intermittent catheterization (CIC), implanted nerve stimulator, or prior procedures affecting bladder function.
- Renal insufficiency or serum creatinine >1.5 times the upper limit of normal, or patients on dialysis.
- Recent pelvic surgery or pelvic radiation within the past 6 months.
- Neurological conditions affecting bladder function or contraindicating catheterization.
- Alcohol or drug abuse.
- Uncontrolled diabetes mellitus.
- Hemodynamic instability, including abnormal heart rate, respiratory rate, blood pressure, or oxygen saturation outside protocol-defined ranges.
- Unstable cardiovascular disorders, including but not limited to myocardial infarction, ischemic heart disease, atrial fibrillation, heart block, Wolff-Parkinson-White syndrome, bradycardia, coronary artery disease, or QT prolongation.
- History of significant liver dysfunction, gastrointestinal bleeding, renal disease, seizures, inflammatory bowel disease, or hepatitis.
- Clinically significant hematologic abnormalities, including leukopenia, thrombocytopenia, or anemia below protocol-defined thresholds.
- Body mass index (BMI) ≥40 kg/m².
- Any medical condition that, in the investigator's opinion, may place the participant at increased risk, confound study results, or interfere with study conduct.
- Recent changes (within 8 weeks) in lower urinary tract interventions, including neuromodulation, tibial nerve stimulation, pelvic floor muscle training, or biofeedback.
- Lifetime history of psychotic or bipolar disorder.
- Active genital herpes or vaginitis.
- Women with urinary symptoms occurring exclusively during menstruation.
- Participation in another interventional clinical trial within 30 days prior to screening.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Open-Label Study to Evaluate the Safety and Efficacy of Two Doses of TRG-200 KIT in Patients With Refractory Overactive Bladder (OAB) : A Pilot Study
This is an open-label, single-center pilot study designed to evaluate the safety, tolerability, and preliminary efficacy of TRG-200 KIT, an intravesical sustained-release oxybutynin formulation, in adult patients with refractory overactive bladder (OAB). The study includes an adaptive two-stage design with initial dose evaluation of two dose levels (150 mg and 300 mg oxybutynin) followed by expansion using the selected dose. TRG-200 KIT is administered via monthly intravesical instillation and aims to provide prolonged local bladder exposure while minimizing systemic absorption and anticholinergic adverse effects.
Read the detailed description
Overactive bladder (OAB) is a prevalent chronic condition characterized by urinary urgency, usually accompanied by increased frequency and nocturia, with or without urgency urinary incontinence. Despite the availability of behavioral, pharmacologic, and invasive therapies, a substantial proportion of patients remain refractory or intolerant to current treatments, particularly oral antimuscarinic agents due to systemic side effects and limited long-term adherence.
This open-label, pilot clinical study (TRGC-05) is designed to evaluate the safety, tolerability, efficacy, and exploratory pharmacokinetics of TRG-200 KIT, a novel intravesical sustained-release delivery system containing oxybutynin. TRG-200 KIT consists of a Carbopol gel matrix followed by intravesical administration of oxybutynin (150 mg or 300 mg), forming a prolonged-release system within the bladder to enhance local therapeutic exposure while reducing systemic absorption.
The study employs an adaptive two-stage design. In Stage 1, approximately 20 participants are enrolled into two sequential dose-evaluation cohorts (10 participants per dose level: 150 mg and 300 mg). Safety, tolerability, and pharmacokinetic data from these participants are reviewed to select the optimal dose. In Stage 2, approximately 30 additional participants are treated with the selected dose to further characterize safety and efficacy.
All participants undergo screening, a single-blind placebo run-in period, and an open-label treatment phase consisting of three monthly intravesical instillations of TRG-200 KIT, followed by post-dose endpoint and end-of-study assessments. Efficacy is primarily evaluated by changes from baseline in micturition frequency and other OAB symptoms using patient voiding diaries and validated questionnaires, including quality-of-life measures. Safety assessments include adverse event monitoring, laboratory tests, vital signs, physical and urological examinations, and post-void residual volume measurements. Exploratory pharmacokinetic assessments are performed in a subset of participants to characterize systemic exposure to oxybutynin following intravesical administration.
The study is conducted at Shaare Zedek Medical Center in Jerusalem, Israel, and is intended to inform dose selection and support further clinical development of TRG-200 KIT as a potential treatment option for patients with refractory OAB.
- Conditions
- Overactive Bladder (OAB)
- Being tested
- TRG-200 KIT
- Keywords
- Refractory Overactive Bladder (OAB)
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRG-200 KITDrug
TRG-200 KIT is administered intravesically as a sustained-release formulation. The investigational product consists of a Carbopol gel matrix followed by intravesical instillation of oxybutynin via a urethral catheter, forming a prolonged-release delivery system within the bladder.
The intervention is designed to provide sustained local bladder exposure while minimizing systemic absorption and anticholinergic adverse effects.
| Study group | Role | What they receive |
|---|---|---|
| TRG-200 KIT - 150 mg (Dose-Evaluation Cohort) | Experimental | Participants receive intravesical administration of TRG-200 KIT containing oxybutynin 150 mg. The investigational product is administered via intravesical instillation following a single-blind placebo run-in period. This arm is part of the initial dose-evaluation stage to assess safety, tolerability, and preliminary efficacy. Receives: Drug: TRG-200 KIT |
| TRG-200 KIT - 300 mg (Dose-Evaluation Cohort) | Experimental | Participants receive intravesical administration of TRG-200 KIT containing oxybutynin 300 mg. The investigational product is administered via intravesical instillation following a single-blind placebo run-in period. This arm is part of the initial dose-evaluation stage to assess safety, tolerability, and preliminary efficacy. Receives: Drug: TRG-200 KIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Average Number of Micturitions per 24 Hours
Change from baseline in the average number of micturitions per 24 hours, as recorded in a 3-day patient voiding diary.
Measured: Baseline to Week 12
Change From Baseline in Average Number of Urgency Episodes per 24 Hours
Change from baseline in the average number of urgency episodes (defined as a sudden and compelling desire to void) per 24 hours, based on the 3-day patient voiding diary.
Measured: Baseline to Week 12
Change From Baseline in Average Number of Urgency Urinary Incontinence (UUI) Episodes per 24 Hours
Change from baseline in the average number of urgency urinary incontinence (UUI) episodes per 24 hours, as recorded in the 3-day patient voiding diary.
Measured: Baseline to Week 12
Secondary outcomes (11)
Proportion of Participants With ≥50% Reduction in Micturitions per 24 Hours
Proportion of participants achieving at least a 50% reduction from baseline in the average number of micturitions per 24 hours, based on the 3-day patient voiding diary.
Measured: Baseline to Week 12
Proportion of Participants With ≥50% Reduction in Urgency Episodes per 24 Hours
Proportion of participants achieving at least a 50% reduction from baseline in the average number of urgency episodes per 24 hours, based on the 3-day patient voiding diary.
Measured: Baseline to Week 12
Proportion of Participants With ≥50% Reduction in Urgency Urinary Incontinence (UUI) Episodes
Proportion of participants achieving at least a 50% reduction from baseline in the average number of urgency urinary incontinence (UUI) episodes per 24 hours.
Measured: Baseline to Week 12
Change From Baseline in Nocturnal Voids per Night
Change from baseline in the average number of nocturnal voids per night, as recorded in the 3-day patient voiding diary.
Measured: Baseline to Week 12
Change From Baseline in Average Voided Volume
Change from baseline in average voided volume (mL), measured using a calibrated measuring device and recorded in the patient voiding diary.
Measured: Baseline to Week 12
Change From Baseline in Quality of Life Score
Change from baseline to Week 12 in quality of life related to lower urinary tract symptoms, assessed using the LUTN questionnaire total score.
The LUTN questionnaire total score ranges from 0 to 100, with higher scores indicating greater symptom burden and poorer quality of life, and lower scores indicating improvement. The outcome measure will be reported as the mean change from baseline.
Measured: Baseline to Week 12
Improvement in Patient Perception of Bladder Condition (PPBC)
Proportion of participants achieving an improvement of at least 1 point on the 6-point Patient Perception of Bladder Condition (PPBC) scale.
Measured: Baseline to Week 12
Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Incidence, severity, and relationship to study treatment of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) will be assessed from first dose through Week 12. Events will be coded using MedDRA and summarized by system organ class, preferred term, severity (mild, moderate, severe), and relationship to study treatment.
Measured: From first dose through End of Study (Week 12)
Change From Baseline in Vital Signs (Blood Pressure, Heart Rate, and Body Temperature)
Change from baseline to Week 12 in systolic blood pressure (mmHg), diastolic blood pressure (mmHg), heart rate (beats per minute), and body temperature (°C). Results will be summarized as mean change from baseline for each parameter.
Measured: Baseline to Week 12
Change From Baseline in Clinical Laboratory Safety Parameters
Change from baseline to Week 12 in clinical laboratory parameters including hematology (hemoglobin, white blood cell count, platelet count) and serum chemistry (creatinine, ALT, AST). Results will be summarized as mean change from baseline and incidence of values outside the normal reference range.
Measured: Baseline to Week 12
Change From Baseline in Post-Void Residual Urine Volume
Change from baseline to Week 12 in post-void residual (PVR) urine volume, measured in milliliters (mL) using bladder ultrasound. Results will be summarized as mean change from baseline.
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start15 Feb 2026 (estimated)
- Primary completion15 Dec 2027 (estimated)
- Study completion15 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive Bladder (OAB)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open-label, parallel-assignment study with two experimental dose-evaluation arms (150 mg and 300 mg). An adaptive two-stage design is used for dose selection, followed by expansion with the selected dose.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Trigone Pharma Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07391878
- Sponsor's protocol ID
- TRGC-05
- Status last verified
- Jan 2026
- First submitted
- 22 Dec 2025
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Study to Evaluate the Safety and Efficacy of Two Doses of TRG-200 KIT in Patients With Refractory Overactive Bladder (OAB) : A Pilot Study
- ClinicalTrials.gov ID
- NCT07391878
- Acronym / sponsor ID
- TRGC-05
- Conditions
- Overactive Bladder (OAB)
- Keywords
- Refractory Overactive Bladder (OAB)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Trigone Pharma Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Feb 2026 (estimated)
- Primary completion
- 15 Dec 2027 (estimated)
- Study completion
- 15 Dec 2027 (estimated)
- First posted
- 6 Feb 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.
This is an open-label, single-center pilot study designed to evaluate the safety, tolerability, and preliminary efficacy of TRG-200 KIT, an intravesical sustained-release oxybutynin formulation, in adult patients with refractory overactive bladder (OAB). The study includes an adaptive two-stage design with initial dose evaluation of two dose levels (150 mg and 300 mg oxybutynin) followed by expansion using the selected dose. TRG-200 KIT is administered via monthly intravesical instillation and aims to provide prolonged local bladder exposure while minimizing systemic absorption and anticholinergic adverse effects.
Detailed description
Overactive bladder (OAB) is a prevalent chronic condition characterized by urinary urgency, usually accompanied by increased frequency and nocturia, with or without urgency urinary incontinence. Despite the availability of behavioral, pharmacologic, and invasive therapies, a substantial proportion of patients remain refractory or intolerant to current treatments, particularly oral antimuscarinic agents due to systemic side effects and limited long-term adherence.
This open-label, pilot clinical study (TRGC-05) is designed to evaluate the safety, tolerability, efficacy, and exploratory pharmacokinetics of TRG-200 KIT, a novel intravesical sustained-release delivery system containing oxybutynin. TRG-200 KIT consists of a Carbopol gel matrix followed by intravesical administration of oxybutynin (150 mg or 300 mg), forming a prolonged-release system within the bladder to enhance local therapeutic exposure while reducing systemic absorption.
The study employs an adaptive two-stage design. In Stage 1, approximately 20 participants are enrolled into two sequential dose-evaluation cohorts (10 participants per dose level: 150 mg and 300 mg). Safety, tolerability, and pharmacokinetic data from these participants are reviewed to select the optimal dose. In Stage 2, approximately 30 additional participants are treated with the selected dose to further characterize safety and efficacy.
All participants undergo screening, a single-blind placebo run-in period, and an open-label treatment phase consisting of three monthly intravesical instillations of TRG-200 KIT, followed by post-dose endpoint and end-of-study assessments. Efficacy is primarily evaluated by changes from baseline in micturition frequency and other OAB symptoms using patient voiding diaries and validated questionnaires, including quality-of-life measures. Safety assessments include adverse event monitoring, laboratory tests, vital signs, physical and urological examinations, and post-void residual volume measurements. Exploratory pharmacokinetic assessments are performed in a subset of participants to characterize systemic exposure to oxybutynin following intravesical administration.
The study is conducted at Shaare Zedek Medical Center in Jerusalem, Israel, and is intended to inform dose selection and support further clinical development of TRG-200 KIT as a potential treatment option for patients with refractory OAB.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Open-label, parallel-assignment study with two experimental dose-evaluation arms (150 mg and 300 mg). An adaptive two-stage design is used for dose selection, followed by expansion with the selected dose.
| Arm | Type | Receives |
|---|---|---|
| TRG-200 KIT - 150 mg (Dose-Evaluation Cohort) | Experimental | Drug: TRG-200 KITParticipants receive intravesical administration of TRG-200 KIT containing oxybutynin 150 mg. The investigational product is administered via intravesical instillation following a single-blind placebo run-in period. This arm is part of the initial dose-evaluation stage to assess safety, tolerability, and preliminary efficacy. |
| TRG-200 KIT - 300 mg (Dose-Evaluation Cohort) | Experimental | Drug: TRG-200 KITParticipants receive intravesical administration of TRG-200 KIT containing oxybutynin 300 mg. The investigational product is administered via intravesical instillation following a single-blind placebo run-in period. This arm is part of the initial dose-evaluation stage to assess safety, tolerability, and preliminary efficacy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Willing and able to provide written informed consent and comply with all study procedures.
- Male or female adults aged 18 years or older.
- Documented diagnosis of overactive bladder (OAB) for more than 6 months, refractory or intolerant to oral anticholinergic or other OAB therapies.
- OAB is defined as urinary urgency, usually accompanied by frequency and/or nocturia, with or without urgency urinary incontinence.
- Ability to perform and tolerate urethral catheterization for intravesical instillation.
Key exclusion criteria (26 listed)
- Pregnant or breastfeeding women, or women of childbearing potential not using acceptable contraception.
- Known contraindication, hypersensitivity, or allergy to oxybutynin or other anticholinergic agents.
- History of 24-hour urine volume >3,000 mL.
- Active urinary tract infection or genitourinary infection at screening (re-screening allowed once after treatment).
- Lower urinary tract pathology that may account for symptoms, including but not limited to:
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 |
|---|---|---|
| TRG-200 KITTRG-200 KIT is administered intravesically as a sustained-release formulation. The investigational product consists of a Carbopol gel matrix followed by intravesical instillation of oxybutynin via a urethral catheter, forming a prolonged-release delivery system within the bladder. The intervention is designed to provide sustained local bladder exposure while minimizing systemic absorption and anticholinergic adverse effects. | Drug | TRG-200 KIT - 150 mg (Dose-Evaluation Cohort), TRG-200 KIT - 300 mg (Dose-Evaluation Cohort) |
Primary outcome
Change From Baseline in Average Number of Micturitions per 24 Hours
Time frame: Baseline to Week 12
Change from baseline in the average number of micturitions per 24 hours, as recorded in a 3-day patient voiding diary.
Change From Baseline in Average Number of Urgency Episodes per 24 Hours
Time frame: Baseline to Week 12
Change from baseline in the average number of urgency episodes (defined as a sudden and compelling desire to void) per 24 hours, based on the 3-day patient voiding diary.
Change From Baseline in Average Number of Urgency Urinary Incontinence (UUI) Episodes per 24 Hours
Time frame: Baseline to Week 12
Change from baseline in the average number of urgency urinary incontinence (UUI) episodes per 24 hours, as recorded in the 3-day patient voiding diary.
11 secondary outcomes
Proportion of Participants With ≥50% Reduction in Micturitions per 24 Hours
Time frame: Baseline to Week 12
Proportion of Participants With ≥50% Reduction in Urgency Episodes per 24 Hours
Time frame: Baseline to Week 12
Proportion of Participants With ≥50% Reduction in Urgency Urinary Incontinence (UUI) Episodes
Time frame: Baseline to Week 12
Change From Baseline in Nocturnal Voids per Night
Time frame: Baseline to Week 12
Change From Baseline in Average Voided Volume
Time frame: Baseline to Week 12
Change From Baseline in Quality of Life Score
Time frame: Baseline to Week 12
Improvement in Patient Perception of Bladder Condition (PPBC)
Time frame: Baseline to Week 12
Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: From first dose through End of Study (Week 12)
Change From Baseline in Vital Signs (Blood Pressure, Heart Rate, and Body Temperature)
Time frame: Baseline to Week 12
Change From Baseline in Clinical Laboratory Safety Parameters
Time frame: Baseline to Week 12
Change From Baseline in Post-Void Residual Urine Volume
Time frame: Baseline to Week 12
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 6 Feb 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TRG-200 KIT in people with Overactive Bladder (OAB), run by Trigone Pharma Ltd. at 1 site in Israel.
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 15 inclusion and 26 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 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Hila Kfir (+972-523313350, hila.k@trigonepharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Average Number of Micturitions per 24 Hours (time frame: Baseline to Week 12). The study lists 3 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 6 Feb 2026.