Clinical trials: Tibial Nerve
Urge Incontinence
Effectiveness of eCoin at Sensory and Subsensory Amplitudes
The goal of this prospective, multi-center, double-blinded randomized controlled is to learn about effectiveness and QOL with eCoin at two different amplitude settings in subjects with urge urinary incontincence (UUI).
- Trial name
- ESSENCE (NCT05882318)
- Testing
- eCoin Peripheral Neurostimulator System
- Where
- 7 sites in United States
- Volunteers
- 38 people
- Sponsor
- Valencia Technologies Corporation
Urge Incontinence
Protect Chronic Tibial Nerve Stimulator (CTNS) System
30 patient Study. All patients implanted with StimGuard Protect System. Patient followed out to 90 days.
- Trial name
- NCT02781636
- Testing
- Device: StimGuard Protect System
- Where
- Belgium
- Volunteers
- 10 people
- Sponsor
- Uro Medical Corporation
Overactive Bladder, Urinary Frequency
FREEOAB Study for Overactive Bladder
This is a prospective, multicenter study that was conducted to evaluate the safety and efficacy of a novel, closed-loop, continuous-sensing wearable neuromodulation system for Overactive Bladder symptom control.
- Conditions
- Overactive Bladder, Urinary Frequency, Urinary Incontinence, Urge, Urinary Urgency
- Trial name
- NCT04547920
- Testing
- Wearable Bladder Modulation System
- Where
- 9 sites in United States
- Volunteers
- 96 people
- Sponsor
- Avation Medical, Inc.
Overactive Bladder (OAB)
Tensi+ for Treating Overactive Bladder
The purpose of the study is to evaluate the safety and effectiveness of the Tensi+ device using Transcutaneous Posterior Tibial Nerve Stimulation (TPTNS) for treating patients suffering from OAB symptoms urinary frequency…
- Trial name
- NCT07300904
- Testing
- Tensi+
- Where
- 3 sites in United States, Canada
- Volunteers
- 60 people
- Sponsor
- Stimuli Technology
Urinary Incontinence, Urge, Urinary Bladder, Overactive
INTIBIA Pivotal Study
Prospective, randomized, double-blind, multicenter study to evaluate the safety and efficacy of an implantable tibial nerve stimulator in subjects with urgency urinary incontinence (UUI).
- Conditions
- Urinary Incontinence, Urge, Urinary Bladder, Overactive, Urinary Bladder Diseases, Urologic Diseases
- Trial name
- NCT05250908
- Testing
- INTIBIA Therapeutic, INTIBIA Non-Therapeutic
- Where
- 22 sites in United States, Netherlands
- Volunteers
- 208 people
- Sponsor
- Coloplast A/S
Premature Ejaculation, Sex Disorder
Effectiveness and Safety of TENS Therapy for Premature Ejaculation
The objective of this clinical trial is to evaluate the effectiveness and safety of transcutaneous posterior tibial nerve stimulation therapy in patients with premature ejaculation.
- Conditions
- Premature Ejaculation, Sex Disorder, TEN
- Trial name
- TENSPE2 (NCT06425224)
- Testing
- Tens therapy, Standard treatment (dapoxetine 30 mg as needed)
- Where
- Mexico
- Volunteers
- 129 people
- Sponsor
- Boston Medical Group
Overactive Bladder (OAB), Refractory Overactive Bladder
Cefar URO - Symptomatic Treatment of Overactive Bladder
A Post-Market Prospective Clinical Investigation to collect PMCF data on the safety and performance of the Cefar URO device when using the preset program P4 (parameter setting: frequency 20Hz, pulse width 200μs) for the…
- Conditions
- Overactive Bladder (OAB), Refractory Overactive Bladder, Urinary Urgency and Frequency
- Trial name
- NCT06659536
- Testing
- Transcutaneous Tibial Nerve Stimulation (TTNS) with the Cefar Uro Device
- Where
- France
- Volunteers
- 53 people
- Sponsor
- DJO UK Ltd
Over Active Bladder
Stimulating Percutaneous Array for Urinary Reflex Control (SPARC)
The Confidanz Smart Patch System consists of a Smart Patch containing one transcutaneous gel electrode and one percutaneous microneedle array electrode that sits directly superficial to the posterior tibial nerve.
- Trial name
- NCT07149103
- Testing
- Percutaneous Tibial Nerve Stimulation
- Where
- 2 sites in Australia
- Volunteers
- 40 people
- Sponsor
- Australis Scientific PTY LTD
Urinary Incontinence, Urge
CAN-Stim Compared to SNS in Treatment of Urinary Urgency Incontinence With Wireless Neuromodulation Technology
This is a prospective, randomized, controlled, multi-center, study in which 150 evaluable subjects will be randomized 1:1 to receive either a Protect CAN-Stim or SNS InterStim® system.
- Trial name
- PROTECT (NCT02577302)
- Testing
- CAN-Stim - Protect CAN-Stim System, SNS - InterStim® System
- Where
- 15 sites in United States
- Volunteers
- 200 people
- Sponsor
- Uro Medical Corporation
Premature Ejaculation
Transcutaneous Posterior Tibial Nerve Stimulation for Premature Ejaculation
Objective: Evaluate the effectiveness and safety of transcutaneous electrostimulation of the posterior tibial nerve alone and combined with standard pharmacological treatment, in men with primary premature ejaculation, compared…
- Trial name
- NCT04207723
- Testing
- Transcutaneous posterior tibial nerve stimulation, Paroxetine
- Where
- Colombia
- Volunteers
- 120 people
- Sponsor
- Boston Medical Group
Overactive Bladder
Overactive Bladder Treatment Using StimRouter Neuromodulation System: A Prospective Randomized Trial
Approximately 20 Study Sites will participate over total 24 months. Study population will consist of adults age 22 or over, reporting overactive bladder (OAB) symptoms for at least 3 months. Primary Study Objectives: 1.
- Trial name
- NCT02873312
- Testing
- StimRouter
- Where
- 19 sites in United States, Canada
- Volunteers
- 180 people
- Sponsor
- Bioness Inc
Urgency Urinary Incontinence
eCoin Tibial Nerve Stimulation for OAB
The study is a single arm, prospective study of the safety and effectiveness of the Valencia Technologies eCoin System to stimulate the tibial nerve for the treatment of patients with refractory urgency urinary incontinence.
- Trial name
- NCT03029624
- Testing
- eCoin
- Where
- 7 sites in United States, New Zealand
- Volunteers
- 46 people
- Sponsor
- Valencia Technologies Corporation
Urinary Bladder, Overactive
Modified Extension Study to the SUmiT Trial: Evaluation of Long Term Therapy With Percutaneous Tibial Nerve Stimulation (PTNS) for Overactive Bladder Symptoms
This is a modified extension study to the SUmiT protocol UPC082008 (NCT00534521) to observe and evaluate long term therapy with PTNS on overactive bladder symptoms.
- Trial name
- STEP (NCT00928395)
- Testing
- Urgent PC
- Where
- 12 sites in United States
- Volunteers
- 50 people
- Sponsor
- Uroplasty, Inc
Overactive Bladder
Clinical Feasibility Study, Implantable Tibial Nerve Stimulator (ITNS)
Study objectives: To report feasibility data for safety and effectiveness of the study device. Study device: Nine Continents Medical implantable tibial nerve stimulator (ITNS) model 9C-680 with programmer model 9C-580.
- Trial name
- NCT04115228
- Testing
- Implantation and neuromodulation therapy
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Nine Continents Medical, Inc.
Overactive Bladder, Urge Incontinence
Pivotal Study of eCoin for Overactive Bladder With Urgency Urinary Incontinence
This trial is a prospective, multicenter, single-arm study of the safety and effectiveness of eCoinTM tibial nerve stimulation in subjects having overactive bladder (OAB) with urgency urinary incontinence (UUI).
- Conditions
- Overactive Bladder, Urge Incontinence, Incontinence, Urinary, Urinary Urge Incontinence
- Trial name
- NCT03556891
- Testing
- eCoin Tibial Nerve Stimulation
- Where
- 15 sites in United States
- Volunteers
- 133 people
- Sponsor
- Valencia Technologies Corporation
Overactive Bladder
A Clinical Study for Magnetic Stimulation of the Posterior Tibial Nerve in Overactive Bladder
To evaluate the safety and feasibility of non-invasive magnetic stimulation of the posterior tibial nerve using the EMKinetics LoFIT Pulse System for treating patients with documented overactive bladder.
- Trial name
- NCT01214265
- Testing
- EMKinetics non-invasive Magnetic neurostimulator
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- EMKinetics, Inc
Overactive Bladder
Evaluation of the The Neuromodulation System for the Treatment of Overactive Bladder Symptoms
To evaluate the efficacy and safety of non-invasive tibial nerve stimulator for the treatment of overactive bladder under the premise of ensuring the safety of the subjects and ensuring the scientific nature of the clinical…
- Trial name
- NCT04999657
- Testing
- Non-invasive low-frequency tibial nerve stimulator (TNS-01)
- Where
- 7 sites in China
- Volunteers
- 109 people
- Sponsor
- Medtecx Co Ltd.
Overactive Bladder, Urge Incontinence
Transcutaneous Tibial Nerve Stimulation: the ZIDA Device Equivalence
Tibial nerve stimulation (TNS) has been shown to be an effective alternative for the management of the overactive bladder (OAB).
- Conditions
- Overactive Bladder, Urge Incontinence, Urinary Incontinence, Urinary Frequency More Than Once at Night
- Trial name
- NCT04470765
- Testing
- Zida
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Exodus Innovations
Premature Ejaculation
TPTNS for Treating Patients With Premature Ejaculation
Background: Transcutaneous posterior tibial nerve stimulation is an effective therapy for controlling urinary incontinence. Premature ejaculation (PE) and urinary incontinence are anatomically and physio-pathologically similar.
- Trial name
- NCT03204890
- Testing
- Transcutaneous Posterior Tibial Nerve Stimulation
- Where
- Colombia
- Volunteers
- 26 people
- Sponsor
- Boston Medical Group
Lower Extremity Anatomy, Peripheral Nerve Anatomy
Anatomical Probability Model for Tibial and Peroneal Motor Entry Points
This completed descriptive cadaveric study mapped the motor entry points of lower-leg muscles supplied by the tibial, superficial peroneal, and deep peroneal nerves.
- Conditions
- Lower Extremity Anatomy, Peripheral Nerve Anatomy, Surgical Anatomy
- Trial name
- NCT07805902
- Testing
- Standardized Cadaveric Lower-Limb Dissection
- Where
- Colombia
- Volunteers
- 20 people
- Sponsor
- Research Inc