Non-invasive Saphenous Nerve Stimulation Therapy for Overactive Bladder

Part of paid clinical trials in Camden, New Jersey.

Sponsor
NinaMED Pty Ltd
Study ID
NCT07780786
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Overactive Bladder (OAB)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Wearable neurostimulation system for saphenous nerve stimulation — DEVICE
    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 release — DRUG
    once daily tolterodine tartrate 4mg ER

Study Details

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.

Key Dates

First listed
Aug 24, 2026
Start date
Sep 10, 2026
Status verified
Jul 2026
Primary completion
Dec 10, 2027
Completion
Jan 30, 2028

Study Design

Enrollment
290 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: NiNA Therapy
    Saphenous nerve stimulation with the NiNA System
  • Active Comparator: Drug: tolterodine tartrate 4mg ER once daily
    tolterodine tartrate 4mg ER, once daily

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 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Virtua Primary CareCamdenNew Jersey08104
Amit Bhalodia, DO (PRINCIPAL_INVESTIGATOR)

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By research site
Virtua Primary Care· Camden, NJ

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