Non-invasive Saphenous Nerve Stimulation Therapy for Overactive Bladder

NCT07780786 | Not Yet Recruiting Phase 3 DMC FDA Drug FDA Device

• 1 other identifier: NiNA MED-001
• Study Type: interventional
• Target: 290
• Locations: 2 countries
• Sites: 2

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. 1.Bladder diary (3-day, consecutive);
2. 2.Self-administered and validated Quality-of-Life questionnaires (see Effectiveness Assessments);
3. 3.Additional assessments of participant satisfaction and preferences will be obtained using participant study surveys and questionnaires at defined study time points.

Conditions

Overactive Bladder (OAB)

Keywords

Overactive Bladder (OAB); saphenous nerve

Outcome Measures

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

  12 weeks

Secondary Outcomes (3)

• Change in mean 24-hour urinary frequency at 12 weeks

  12 weeks

• Percent reduction in mean UUI episodes per 24-hours at 12 weeks

  12 weeks

• 50% change in mean daily (per 24 hours) UUI episodes at 12 weeks

  12 weeks

Study Arms (2)

NiNA Therapy

EXPERIMENTAL

Saphenous nerve stimulation with the NiNA System

Device: Wearable neurostimulation system for saphenous nerve stimulation

Drug: tolterodine tartrate 4mg ER once daily

ACTIVE COMPARATOR

tolterodine tartrate 4mg ER, once daily

Drug: tolterodine tartrate 4 mg extended release

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.

NiNA Therapy

tolterodine tartrate 4 mg extended release DRUG

once daily tolterodine tartrate 4mg ER

Drug: tolterodine tartrate 4mg ER once daily

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• episodes of UUI demonstrated on a consecutive 3-day bladder diary
• 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)

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• NinaMED Pty Ltd: lead

Study Sites (2)

Virtua Primary Care

Camden, New Jersey, 08104, United States

Location

Western Urology

Maribyrnong, Victoria, 3032, Australia

Location

Related Publications (1)

• 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.

  PMID: 29464764 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Tolterodine Tartrate

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropanolamine; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Cresols; Phenols

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: August 24, 2026
• Study Start: September 10, 2026
• Primary Completion (Estimated): December 10, 2027
• Study Completion (Estimated): January 30, 2028
• Last Updated: August 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

AU (1); US (1)