Who is eligible for clinical trial NCT07780786?

Participants must meet protocol criteria for Overactive Bladder (OAB). Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT07780786 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-08-19

Non-invasive Saphenous Nerve Stimulation Therapy for Overactive Bladder (NCT07780786)

🟡 Not Yet Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: NinaMED Pty Ltd

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (33 items).

Location: Virtua Primary Care — Camden, New Jersey

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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
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)

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (2 Sites)

Virtua Primary Care — Camden, New Jersey
Western Urology — Maribyrnong, Victoria

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗