Non-invasive Saphenous Nerve Stimulation Therapy for Overactive Bladder
brief 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. 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.
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:
official title
Non-invasive Saphenous Nerve Stimulation Therapy for Overactive Bladder: A Randomized Controlled Trial (NOVASTIM)