Non-invasive Saphenous Nerve Stimulation Therapy for Overactive Bladder
ConditionOveractive Bladder (OAB)
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorNinaMED Pty Ltd
About this trial
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:
1. Bladder diary (3-day, consecutive); 2. Self-administered and validated Quality-of-Life questionnaires (see Effectiveness Assessments); 3. Additional assessments of participant satisfaction and preferences will be obtained using participant study surveys and questionnaires at defined study time points.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Wearable neurostimulation system for saphenous nerve stimulation
DeviceDevice: 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 release
Drugonce daily tolterodine tartrate 4mg ER
Treatment groups
290 Participants
are divided into 2 treatment groupsGroup A: NiNA TherapyExperimental treatment 1 intervention
Group B: Drug: tolterodine tartrate 4mg ER once dailyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
12 weeksSecondary outcomes
1
Change in mean 24-hour urinary frequency at 12 weeks
Change in mean 24-hour urinary frequency, measured using participant diary at 12 weeks
Time frame
12 weeks2
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
Time frame
12 weeks3
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
Time frame
12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: