Overactive Bladder (OAB)Phase 3NOVASTIMNCT07780786
Non-invasive Saphenous Nerve Stimulation Therapy for Overactive Bladder
A Phase 3 study testing Wearable neurostimulation system for saphenous nerve stimulation and tolterodine tartrate 4 mg extended release in people with Overactive Bladder (OAB), run by NinaMED Pty Ltd at 2 sites in 2 countries.
Trial summary
The goal of this clinical trial is to study the NiNA System and how it works to treat overactive bladder. Up to 290 participants will be enrolled in the study in the USA and Australia. 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?
- Wearable neurostimulation system for saphenous nerve stimulation and tolterodine tartrate 4 mg extended release
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 10 Sep 2026to 30 Jan 2028
- Phase
- Phase 3
- 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
- Male and female nonhospitalized individuals, 18 years of age or older, who are ambulatory and able to use the NiNA device, cell-phone Apps, and toilet independently
- Self-reported symptoms of OAB for at least 6 months
- Self-reported to be able to read and understand English sufficiently to provide informed consent
- Have the required language, cognitive and physical capabilities to comply with study requirements per study investigator or delegate
- Urinary frequency (eight or more micturitions per 24 hours)
- 3 - 27 episodes of UUI demonstrated on a consecutive 3-day bladder diary
Show all 9Show fewer
- No pharmacological treatment of OAB for 2 weeks prior to screening
- Demonstrates a positive nerve recruitment test in at least one leg
- Willing to utilize effective contraception for period of study if female of childbearing potential (e.g., complete abstinence, oral contraceptives, patch, barrier (diaphragm or condom), intrauterine contraceptive injection, intrauterine device or hormonal vaginal contraceptive ring)
Who cannot join
- Unable to ambulate independently.
- Has indwelling urinary catheter or requires intermittent catheterization.
- Any current or prior use of tolterodine (any formulation)
- Currently treated with any azole antifungals (e.g., ketoconazole, itraconazole, miconazole), macrolide antibiotics (erythromycin, clarithromycin), cyclosporine or vinblastine.
- Previously treated with advanced therapy treatment options for OAB including botulinum toxin injections, sacral neuromodulation, percutaneous tibial nerve stimulation or surgery.
- Has an active implantable device such as a pacemaker, implantable cardioverter-defibrillator (ICD), implanted neurostimulator.
Show all 32Show fewer
- Has bilateral knee or tibial plateau implants.
- Treatment with advanced therapy options for stress urinary incontinence (SUI) including incontinence slings, surgery and urethral bulking within the previous 12 months
- Has an artificial urinary sphincter implant.
- Has previously participated in any OAB clinical research.
- Past or current history of clinically significant bladder outlet obstruction or urinary retention.
- Past or current history of gastric retention, narrow-angle glaucoma, or significant reduction in renal or liver function.
- Has primary stress urinary incontinence or mixed incontinence where the stress component is greater than one-third of the urgency urinary incontinence component based on the 3-day bladder diary at baseline.
- Has more than 3 occurrences of nocturia per night, on average, based on the 3-day bladder diary at baseline.
- Neurogenic lower urinary tract dysfunction as determined by medical history.
- Unable to comply with the study protocol including inability to utilize smart phone technology ("app" use).
- Unable to place and use the investigational device and use supporting software per study personnel.
- Exhibits neurologic deficit secondary to neurologic disease or injury that could impact either saphenous nerve or pelvic floor function, per study investigator.
- Has inadequate skin integrity or any evidence of an infection or inflammation in both legs within the target treatment area per study investigator.
- Has significant scarring on both legs around the treatment sites from prior surgery or injury, per study investigator.
- Has significant skin condition, peripheral neuropathy or clinically significant edema that, in the opinion of the investigator, would interfere with transcutaneous saphenous nerve stimulation.
- History of recurrent urinary tract infections (two or more within 6 months or 3 in one year).
- Untreated urinary tract infection at the time of screening assessment.
- Has clinically significant abnormalities on the urine dipstick test or per the discretion of the study investigator.
- Is or could be pregnant or breastfeeding based on self-report or a urine pregnancy test.
- Self-reports clinically significant and untreated pelvic organ prolapse that protrudes beyond the vaginal introitus.
- Displays polyuria with a daily urine output > 3000 ml/day per participant's baseline frequency-volume chart at screening.
- Self-reports significant lower urinary tract pain or diagnosis of interstitial cystitis/bladder pain syndrome.
- Has a self-reported history of lower urinary tract cancers of any etiology, active pelvic cancer diagnosis or radiation therapy of the pelvic area.
- Experiences uncontrolled diabetes that would impact study enrollment or completion, in the opinion of the investigator.
- Cannot tolerate 30 minutes of stimulation above saphenous nerve recruitment thresholds.
- Any conditions or issues that, in the opinion of the PI, may make the participant not be a good fit for trial and/or place them at high risk of not completing the study
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site
Virtua Primary Care
Camden, New Jersey, 08104
Amit Bhalodia, DO
Australia1 site
Western Urology
Maribyrnong, Victoria, 3032
Homi Zargar, Asoc/Prof
About this study
Official title: Non-invasive Saphenous Nerve Stimulation Therapy for Overactive Bladder: A Randomized Controlled Trial (NOVASTIM)
The goal of this clinical trial is to study the NiNA System and how it works to treat overactive bladder. Up to 290 participants will be enrolled in the study in the USA and Australia.
The investigational NiNA System includes a wearable neurostimulator device ("NiNA" or "Device"), a flexible wrap to secure the Device to the calf during treatment of the saphenous nerve (SAFN), with smartphone-based control application with patient support features that allow users to control the stimulation therapy and receive reminder on days they are supposed to provide therapy ("NiNA App") or an enhanced smartphone-based control application which also has patient support features and educational multi-media content ("NiNA Care App").
Read more
The main questions the study aims to answer are: 1) How does the NiNA system compare to a common overactive bladder (OAB) medication; 2) How well does the NiNA system improve overactive bladder symptoms; and, 3) Does the NiNA system produce any unwanted side-effects.
In the study half the participants randomly receive the NiNA system and the other half first receive the OAB medication and later are treated with the NiNA System.
The Participants in the investigative Device arm (NiNA) will:
Provide NiNA system treatments very day for 30 minutes during a 28 day induction/restore period. This is followed by maintenance treatments (30 minutes, 3-times a week) until 12 weeks, when the primary endpoint data are measured. Participants continue maintenance (30 minutes, 3-times a week) for the remaining 52 weeks of the study.
Participants in the OAB medication arm will:
Take a capsule every day (tolterodine tartrate extended release (ER) 4 mg) for twelve weeks.
At 12 weeks, OAB medication arm Participants will stop taking the OAB medication and cross-over to treatment with the NiNA system. One-third of the cross-over Participants will be use a phone-based software application that allows them to control the neurostimulator and receive reminders on days the are scheduled to provide their therapy (NiNA App) and the other two-thirds of the cross-over Participants will use a phone based software application that also contains educational videos that reinforce the therapy (NiNA Care App). Assignment to each arm is random.
The study will measure primary and secondary endpoints completely remotely using digital questionnaires that are presented to Participants on a specialized software application installed on their phones ("Study App"):
Changes in OAB symptoms at a defined set of time points using the following instruments:
- Bladder diary (3-day, consecutive);
- Self-administered and validated Quality-of-Life questionnaires (see Effectiveness Assessments);
- Additional assessments of participant satisfaction and preferences will be obtained using participant study surveys and questionnaires at defined study time points.
Read the detailed description
The objective of this study is to assess that Saphenous nerve (SAFN) stimulation with the NiNA System is at least non-inferior to the use of tolterodine tartrate 4 mg extended release (ER), taken daily in reducing the number of daily urgency urinary incontinence (UUI) episodes.
The investigational device is the NiNA System which includes a wearable neurostimulator device with a stimulation matrix having 6 conductive gel pads that allow patients to provide targeted neurostimulation by adjusting stimulation field geometry ("NiNA" or "Device"), a flexible wrap to secure the neurostimulator and stimulation matrix to the upper calf during treatment, and a smartphone-based control application with patient support features ("NiNA App") or an alternate smartphone-based control application with patient support features and educational content ("NiNA Care App").
The active control in the study is Tolterodine tartrate 4 mg capsules, extended-release (ER) capsules, taken daily, which are indicated for the treatment of individuals having OAB with symptoms of urinary incontinence, urgency, and frequency.
The study design is a Prospective, dual center, randomized, adaptive, decentralized trial of the NiNA System vs an active control.
The study will enroll up to 290 participants, based on an adaptive design with prospectively planned sample size re-estimation (SSR) when 50% of the minimal estimated total study cohort (i.e., 108 of 216 participants combined across the Investigational Device Group \& Active Control Group) has achieved the primary endpoint of 12 weeks.
Participants will be randomized 1:1 to receive therapy using the investigational device (NiNA with NiNA App) or the active control. In the investigational device arm, participants will stimulate the SAFN for 30 minutes daily during a 28-day NiNA therapy induction phase and then for 30 minutes, 3-times a week during therapy maintenance which is provided beyond the induction phase, to maintain potential therapeutic benefit. Once the primary endpoint at 12 weeks is reached, investigational device arm Participants will continue with the maintenance phase therapy until the end of the study at 52 weeks.
In the active control arm, participants take tolterodine tartrate ER (4 mg), daily for 12 weeks. After 12 weeks, participants in this arm cross-over and are treated with the investigational device therapy. The cross-over group will be randomized 1:2 at the time of crossover to either:
- the investigational device (NiNA) and the NiNA App, that provides therapy reminders and allows user to control the Device; or,
- the investigational device (NiNA) and an app that additionally has multimedia educational content (NiNA Care App).
Upon crossover at 12 weeks, participants will immediately begin an induction stimulation schedule (30 minutes daily for 28 days) with no washout of the active control drug.
Following the 28-days induction phase, the post-crossover cohorts will transition to a maintenance schedule (30 minutes of stimulation for 3-days per-week) until the end of the study at 48 weeks.
Participant compliance and adherence with the NiNA therapy will be assessed at various study time points using the compliance and recordkeeping features associated with the investigational Device software app and a Study App.
Active control (tolterodine) compliance and adherence through the primary endpoint (12 weeks) will be assessed using standard digital clinical study measures such as a medication diary in the Study App.
- Conditions
- Overactive Bladder (OAB)
- Being tested
- Wearable neurostimulation system for saphenous nerve stimulation, tolterodine tartrate 4 mg extended release
- Keywords
- Overactive Bladder (OAB), saphenous nerve
- 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.
Wearable neurostimulation system for saphenous nerve stimulationDevice
Device: NiNA System The NiNA System includes a wearable neurostimulator device and stimulation matrix with 6 conductive pads that provide transcutaneous stimulation ("NiNA"), that are secured to the upper calf during treatment using a flexible wrap. The system includes a either a) a basic version smartphone-based control application with patient support features ("NiNA with NiNA App") or a more advanced version which also includes multi-media educational content ("NiNA with NiNA Care App"). The system uses field steering controls to improve targeted electrical stimulation of the saphenous nerve.
tolterodine tartrate 4 mg extended releaseDrug
once daily tolterodine tartrate 4mg ER
| Study group | Role | What they receive |
|---|---|---|
| NiNA Therapy | Experimental | Saphenous nerve stimulation with the NiNA System Receives: Device: Wearable neurostimulation system for saphenous nerve stimulation |
| Drug: tolterodine tartrate 4mg ER once daily | Active comparator | tolterodine tartrate 4mg ER, once daily Receives: Drug: tolterodine tartrate 4 mg extended release |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement in the number of UUI episodes per day using the NiNA MED system as compared to tolterodine tartrate 4mg ER
The primary objective of this study is to determine whether the change from baseline to week 12 in the number of UUI episodes per day due to the use of the NiNA System is non-inferior to the change in UUI episodes per day due to the use of daily tolterodine tartrate (ER 4 mg). If the test for non-inferiority is met, a test for superiority will be conducted
Measured: 12 weeks
Secondary outcomes (3)
Change in mean 24-hour urinary frequency at 12 weeks
Change in mean 24-hour urinary frequency, measured using participant diary at 12 weeks
Measured: 12 weeks
Percent reduction in mean UUI episodes per 24-hours at 12 weeks
Measurement and recording in participant diaries of UUI episodes per 24-hours at 12 weeks
Measured: 12 weeks
50% change in mean daily (per 24 hours) UUI episodes at 12 weeks
50%change in mean daily (24 hours) UUI episodes, as reported in the participant diary, at 12 weeks
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start10 Sep 2026 (estimated)
- Primary completion10 Dec 2027 (estimated)
- Study completion30 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized 1:1 to: a) the wearable investigational neurostimulator ("NiNA") and smartphone software ("NiNA App); or a) the active control, (tolterodine tartrate 4mg ER, taken daily). The investigational device arm participants stimulate the saphenous nerve (SAFN) below the knee for 30 min daily sessions during a 28 day induction period followed by 30 min sessions delivered 3x each week during maintenance (to maintain potential therapy benefit). After the 12-week primary endpoint, participants continue maintenance until 52 weeks. Participants in the active control arm receive OAB medication until the primary endpoint at 12 weeks. They then cross-over and are treated using investigational device therapy. The crossover group is randomized 1:2 to either: 1. the investigational device (NiNA with NiNA App); or, 2. the investigational device with an App that also has multimedia educational content (NiNA with NiNA Care).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 290 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NinaMED Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07780786
- Sponsor's protocol ID
- NiNA MED-001
- Acronym
- NOVASTIM
- Status last verified
- Jul 2026
- First submitted
- 11 Aug 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The results of this study will not be published or communicated to any scientific meeting, lay press or person without the express written agreement of the sponsor. Should the Investigator wish to publish or present the results of this study, the Investigator agrees to provide Sponsor with an abstract, manuscript, and/or presentation for review 60 days prior to submission for publication/presentation. Sponsor retains the right to delete from the manuscript confidential information and to object to suggested publication and/or its timing (at Sponsors' sole discretion). This also applies to any amendments that are requested by journal reviewers or editors. Only aggregate data without individually identifiable information will be used for publications and other forms of public dissemination of study safety and efficacy outcomes. Any publication of the study data will acknowledge each PI or sub-investigator that contributed to the study
Publications
MacDiarmid SA, John MS, Yoo PB. A pilot feasibility study of treating overactive bladder patients with percutaneous saphenous nerve stimulation. Neurourol Urodyn. 2018 Jun;37(5):1815-1820. doi: 10.1002/nau.23531. Epub 2018 Feb 21.
PubMed 29464764
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Saphenous Nerve Stimulation Therapy for Overactive Bladder: A Randomized Controlled Trial (NOVASTIM)
- ClinicalTrials.gov ID
- NCT07780786
- Acronym / sponsor ID
- NOVASTIM / NiNA MED-001
- Conditions
- Overactive Bladder (OAB)
- Keywords
- Overactive Bladder (OAB), saphenous nerve
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- NinaMED Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 10 Sep 2026 (estimated)
- Primary completion
- 10 Dec 2027 (estimated)
- Study completion
- 30 Jan 2028 (estimated)
- First posted
- 24 Aug 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.
The goal of this clinical trial is to study the NiNA System and how it works to treat overactive bladder. Up to 290 participants will be enrolled in the study in the USA and Australia.
The investigational NiNA System includes a wearable neurostimulator device ("NiNA" or "Device"), a flexible wrap to secure the Device to the calf during treatment of the saphenous nerve (SAFN), with smartphone-based control application with patient support features that allow users to control the stimulation therapy and receive reminder on days they are supposed to provide therapy ("NiNA App") or an enhanced smartphone-based control application which also has patient support features and educational multi-media content ("NiNA Care App").
The main questions the study aims to answer are: 1) How does the NiNA system compare to a common overactive bladder (OAB) medication; 2) How well does the NiNA system improve overactive bladder symptoms; and, 3) Does the NiNA system produce any unwanted side-effects.
In the study half the participants randomly receive the NiNA system and the other half first receive the OAB medication and later are treated with the NiNA System.
The Participants in the investigative Device arm (NiNA) will:
Provide NiNA system treatments very day for 30 minutes during a 28 day induction/restore period. This is followed by maintenance treatments (30 minutes, 3-times a week) until 12 weeks, when the primary endpoint data are measured. Participants continue maintenance (30 minutes, 3-times a week) for the remaining 52 weeks of the study.
Participants in the OAB medication arm will:
Take a capsule every day (tolterodine tartrate extended release (ER) 4 mg) for twelve weeks.
At 12 weeks, OAB medication arm Participants will stop taking the OAB medication and cross-over to treatment with the NiNA system. One-third of the cross-over Participants will be use a phone-based software application that allows them to control the neurostimulator and receive reminders on days the are scheduled to provide their therapy (NiNA App) and the other two-thirds of the cross-over Participants will use a phone based software application that also contains educational videos that reinforce the therapy (NiNA Care App). Assignment to each arm is random.
The study will measure primary and secondary endpoints completely remotely using digital questionnaires that are presented to Participants on a specialized software application installed on their phones ("Study App"):
Changes in OAB symptoms at a defined set of time points using the following instruments:
- Bladder diary (3-day, consecutive);
- Self-administered and validated Quality-of-Life questionnaires (see Effectiveness Assessments);
- Additional assessments of participant satisfaction and preferences will be obtained using participant study surveys and questionnaires at defined study time points.
Detailed description
The objective of this study is to assess that Saphenous nerve (SAFN) stimulation with the NiNA System is at least non-inferior to the use of tolterodine tartrate 4 mg extended release (ER), taken daily in reducing the number of daily urgency urinary incontinence (UUI) episodes.
The investigational device is the NiNA System which includes a wearable neurostimulator device with a stimulation matrix having 6 conductive gel pads that allow patients to provide targeted neurostimulation by adjusting stimulation field geometry ("NiNA" or "Device"), a flexible wrap to secure the neurostimulator and stimulation matrix to the upper calf during treatment, and a smartphone-based control application with patient support features ("NiNA App") or an alternate smartphone-based control application with patient support features and educational content ("NiNA Care App").
The active control in the study is Tolterodine tartrate 4 mg capsules, extended-release (ER) capsules, taken daily, which are indicated for the treatment of individuals having OAB with symptoms of urinary incontinence, urgency, and frequency.
The study design is a Prospective, dual center, randomized, adaptive, decentralized trial of the NiNA System vs an active control.
The study will enroll up to 290 participants, based on an adaptive design with prospectively planned sample size re-estimation (SSR) when 50% of the minimal estimated total study cohort (i.e., 108 of 216 participants combined across the Investigational Device Group \& Active Control Group) has achieved the primary endpoint of 12 weeks.
Participants will be randomized 1:1 to receive therapy using the investigational device (NiNA with NiNA App) or the active control. In the investigational device arm, participants will stimulate the SAFN for 30 minutes daily during a 28-day NiNA therapy induction phase and then for 30 minutes, 3-times a week during therapy maintenance which is provided beyond the induction phase, to maintain potential therapeutic benefit. Once the primary endpoint at 12 weeks is reached, investigational device arm Participants will continue with the maintenance phase therapy until the end of the study at 52 weeks.
In the active control arm, participants take tolterodine tartrate ER (4 mg), daily for 12 weeks. After 12 weeks, participants in this arm cross-over and are treated with the investigational device therapy. The cross-over group will be randomized 1:2 at the time of crossover to either:
- the investigational device (NiNA) and the NiNA App, that provides therapy reminders and allows user to control the Device; or,
- the investigational device (NiNA) and an app that additionally has multimedia educational content (NiNA Care App).
Upon crossover at 12 weeks, participants will immediately begin an induction stimulation schedule (30 minutes daily for 28 days) with no washout of the active control drug.
Following the 28-days induction phase, the post-crossover cohorts will transition to a maintenance schedule (30 minutes of stimulation for 3-days per-week) until the end of the study at 48 weeks.
Participant compliance and adherence with the NiNA therapy will be assessed at various study time points using the compliance and recordkeeping features associated with the investigational Device software app and a Study App.
Active control (tolterodine) compliance and adherence through the primary endpoint (12 weeks) will be assessed using standard digital clinical study measures such as a medication diary in the Study App.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomized 1:1 to: a) the wearable investigational neurostimulator ("NiNA") and smartphone software ("NiNA App); or a) the active control, (tolterodine tartrate 4mg ER, taken daily). The investigational device arm participants stimulate the saphenous nerve (SAFN) below the knee for 30 min daily sessions during a 28 day induction period followed by 30 min sessions delivered 3x each week during maintenance (to maintain potential therapy benefit). After the 12-week primary endpoint, participants continue maintenance until 52 weeks. Participants in the active control arm receive OAB medication until the primary endpoint at 12 weeks. They then cross-over and are treated using investigational device therapy. The crossover group is randomized 1:2 to either: 1. the investigational device (NiNA with NiNA App); or, 2. the investigational device with an App that also has multimedia educational content (NiNA with NiNA Care).
| Arm | Type | Receives |
|---|---|---|
| NiNA Therapy | Experimental | Device: Wearable neurostimulation system for saphenous nerve stimulationSaphenous nerve stimulation with the NiNA System |
| Drug: tolterodine tartrate 4mg ER once daily | Active comparator | Drug: tolterodine tartrate 4 mg extended releasetolterodine tartrate 4mg ER, once daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male and female nonhospitalized individuals, 18 years of age or older, who are ambulatory and able to use the NiNA device, cell-phone Apps, and toilet independently
- Self-reported symptoms of OAB for at least 6 months
- Self-reported to be able to read and understand English sufficiently to provide informed consent
- Have the required language, cognitive and physical capabilities to comply with study requirements per study investigator or delegate
- Urinary frequency (eight or more micturitions per 24 hours)
Key exclusion criteria (32 listed)
- Unable to ambulate independently.
- Has indwelling urinary catheter or requires intermittent catheterization.
- Any current or prior use of tolterodine (any formulation)
- Currently treated with any azole antifungals (e.g., ketoconazole, itraconazole, miconazole), macrolide antibiotics (erythromycin, clarithromycin), cyclosporine or vinblastine.
- Previously treated with advanced therapy treatment options for OAB including botulinum toxin injections, sacral neuromodulation, percutaneous tibial nerve stimulation or surgery.
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 |
|---|---|---|
| Wearable neurostimulation system for saphenous nerve stimulationDevice: NiNA System The NiNA System includes a wearable neurostimulator device and stimulation matrix with 6 conductive pads that provide transcutaneous stimulation ("NiNA"), that are secured to the upper calf during treatment using a flexible wrap. The system includes a either a) a basic version smartphone-based control application with patient support features ("NiNA with NiNA App") or a more advanced version which also includes multi-media educational content ("NiNA with NiNA Care App"). The system uses field steering controls to improve targeted electrical stimulation of the saphenous nerve. | Device | NiNA Therapy |
| tolterodine tartrate 4 mg extended releaseonce daily tolterodine tartrate 4mg ER | Drug | Drug: tolterodine tartrate 4mg ER once daily |
Primary outcome
Measurement in the number of UUI episodes per day using the NiNA MED system as compared to tolterodine tartrate 4mg ER
Time frame: 12 weeks
The primary objective of this study is to determine whether the change from baseline to week 12 in the number of UUI episodes per day due to the use of the NiNA System is non-inferior to the change in UUI episodes per day due to the use of daily tolterodine tartrate (ER 4 mg). If the test for non-inferiority is met, a test for superiority will be conducted
3 secondary outcomes
Change in mean 24-hour urinary frequency at 12 weeks
Time frame: 12 weeks
Percent reduction in mean UUI episodes per 24-hours at 12 weeks
Time frame: 12 weeks
50% change in mean daily (per 24 hours) UUI episodes at 12 weeks
Time frame: 12 weeks
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 24 Aug 2026.
- Background: PubMed 29464764MacDiarmid SA, John MS, Yoo PB. A pilot feasibility study of treating overactive bladder patients with percutaneous saphenous nerve stimulation. Neurourol Urodyn. 2018 Jun;37(5):1815-1820. doi: 10.1002/nau.23531. Epub 2018 Feb 21.
- Individual participant dataSharing planned: Yes. The results of this study will not be published or communicated to any scientific meeting, lay press or person without the express written agreement of the sponsor. Should the Investigator wish to publish or present the results of this study, the Investigator agrees to provide Sponsor with an abstract, manuscript, and/or presentation for review 60 days prior to submission for publication/presentation. Sponsor retains the right to delete from the manuscript confidential information and to object to suggested publication and/or its timing (at Sponsors' sole discretion). This also applies to any amendments that are requested by journal reviewers or editors. Only aggregate data without individually identifiable information will be used for publications and other forms of public dissemination of study safety and efficacy outcomes. Any publication of the study data will acknowledge each PI or sub-investigator that contributed to the study
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Wearable neurostimulation system for saphenous nerve stimulation and tolterodine tartrate 4 mg extended release in people with Overactive Bladder (OAB), run by NinaMED Pty Ltd at 2 sites in 2 countries.
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 9 inclusion and 32 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 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Australia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
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?
Measurement in the number of UUI episodes per day using the NiNA MED system as compared to tolterodine tartrate 4mg ER (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07780786, which also lists 1 linked publication.
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 24 Aug 2026.