Clinical trials: Sacral Neuromodulation
Urinary Retention, Urinary Urge Incontinence
Axonics SacRal NeuromodulaTIon System RegisTRY Study
To assess the post-market clinical outcomes with use of the Axonics Sacral Neuromodulation System(s).
- Conditions
- Urinary Retention, Urinary Urge Incontinence, Urgency-Frequency, Fecal Incontinence
- Trial name
- ARTISTRY (NCT05064384)
- Where
- 27 sites in United States, Canada
- Volunteers
- 272 people
- Sponsor
- Axonics, Inc.
Urinary Urgency Incontinence
Post-Approval Study of the Neuspera Sacral Neuromodulation System
Prospective, multi-center, single-arm, post-approval study is designed to assess the long-term safety and efficacy data of the Neuspera Sacral Neuromodulation (SNM) System following commercial approval of the Neuspera SNM System.
- Trial name
- NSM-005 (NCT07144813)
- Testing
- Neuspera Implantable Sacral Neuromodulation System
- Where
- 20 sites in United States
- Volunteers
- 116 people
- Sponsor
- Neuspera Medical, Inc.
Ulcerative Colitis, Inflammatory Bowel Diseases
BOOM-IBD2 Pivotal Clinical Trial
Ulcerative colitis is a long-lasting condition that causes swelling and sores in the large intestine. This study tests whether a small device placed under the skin can help reduce bowel urgency in people with ulcerative colitis.
- Trial name
- NCT06571669
- Testing
- Neuromodulation
- Where
- 19 sites in United States
- Volunteers
- 137 people
- Sponsor
- Boomerang Medical
Refractory Overactive Bladder
Clinical Trial of Sacral Neuromodulation for Treatment of Refractory Overactive Bladder (OAB)
Evaluate the long-term clinical effectiveness and safety of the PINS Sacral Neuromodulation to patients with refractory Overactive Bladder.
- Trial name
- NCT02619721
- Testing
- PINS SNS
- Where
- China
- Volunteers
- 7 people
- Sponsor
- Beijing Pins Medical Co., Ltd
Overactive Bladder
Treatment of REfractory Overactive BLadder With the AXonics Sacral Neuromodulation System (RELAX-OAB)
The RELAX-OAB (Treatment of REfractory Overactive BLadder with the AXonics Sacral Neuromodulation System) is a post-market clinical follow-up (PMCF) study designed to confirm the performance of the Axonics Sacral Neuromodulation…
- Trial name
- RELAX-OAB (NCT02620410)
- Testing
- Axonics Sacral Neuromodulation (SNM) System
- Where
- 6 sites in Belgium, France and 2 more
- Volunteers
- 51 people
- Sponsor
- Axonics, Inc.
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
Refractory Overactive Bladder
A Study to Compare the Efficacy and Safety of Ultrasound Guided Lead Implantation for Sacral Neuromodulation (SNM) in Subjects With Overactive Bladder (OAB) With X-Ray Guided Technique
Overactive bladder(OAB,Urgency) was determined by International Continence Society as Urinary urgency, usually accompanied by frequency and nocturia, with or without urgency urinary incontinence, in the absence of urinary tract…
- Trial name
- NCT02946723
- Testing
- ultrasound, X-ray
- Volunteers
- 30 people
- Sponsor
- Beijing Pins Medical Co., Ltd
Fecal Incontinence
French Post-Inscription Study on Sacral Neuromodulation in the Treatment of Fecal Incontinence
The aim of this observational study is to evaluate the utilization in the clinical practice, effectiveness, explantation and re-intervention rate, complications and adverse events of InterStim system in patients indicated to…
- Trial name
- NCT01957969
- Testing
- Sacral Nerve Stimulation
- Where
- 16 sites in France
- Volunteers
- 234 people
- Sponsor
- MedtronicNeuro
Fecal Incontinence
Axonics R20 Post-Market Clinical Follow-up (PMCF) Study for the Indication of Fecal Incontinence
Single-Arm, multi-center, prospective, open-label registry study for commercially available rechargeable implantable neurostimulator (INS model 5101); also referred to as R20.
- Trial name
- NCT07499258
- Testing
- Axonics SNM System INS Model 5101 (R20)
- Where
- 5 sites in United States, United Kingdom
- Volunteers
- 55 people
- Sponsor
- Axonics, Inc.
Urinary Urge Incontinence
Study of 30-Minute Stimulation With the Neuspera Sacral Neuromodulation (SNM) System
Single-arm study conducted in participants for the treatment of urinary urge incontinence in patients who have failed, could not tolerate, or were not a candidate for more conservative treatments.
- Trial name
- NCT07247136
- Testing
- Neuspera Implantable Sacral Neuromodulation System
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Neuspera Medical, Inc.
Overactive Bladder (OAB)
INOPASE - Performance and Safety Study of a Personalised SNM System
The goal of this clinical trial is to learn whether a new sacral neuromodulation (SNM) system (INO-SNM-01) can safely and effectively sense bladder nerve activity and provide stimulation to help manage symptoms of refractory…
- Trial name
- NCT07193407
- Testing
- Sacral Neuromodulation System
- Where
- 2 sites in Australia
- Volunteers
- 10 people
- Sponsor
- INOPASE Pty Ltd
Urinary Incontinence, Urge
Sacral Nerve Stimulation to Treat Urgency Urinary Incontinence With Wireless Neuromodulation
The purpose of this pivotal study is to illustrate the safety and effectiveness of the StimGuard Sacral Nerve Stimulation (SNS) System in the treatment refractory urge incontinence.
- Trial name
- NCT02434874
- Testing
- StimGuard Sacral Nerve Stimulator System
- Where
- United States
- Sponsor
- Uro Medical Corporation
Urinary Incontinence, Urge
Axonics SacRal NeuromodulaTIon System for Urinary Urgency Incontinence TreatmeNt
The ARTISAN-SNM study is designed to evaluate the safety and effectiveness of the Axonics Sacral Neuromodulation System as an aid in the treatment of the symptoms of urinary urgency incontinence (UUI) in patients who have failed…
- Trial name
- ARTISAN-SNM (NCT03327948)
- Testing
- Axonics Sacral Neuromodulation System (SNM) System
- Where
- 4 sites in United States, Netherlands and 1 more
- Volunteers
- 129 people
- Sponsor
- Axonics, Inc.
Overactive Bladder Syndrome, Urinary Urge Incontinence
Cycling Study With the Axonics System
A prospective, multi-center, study comparing continuous sacral neuromodulation (SNM) stimulation to daily cyclic stimulation of 2 hours "on" and 22 hours "off" using the Axonics System.
- Conditions
- Overactive Bladder Syndrome, Urinary Urge Incontinence, Sacral Neuromodulation
- Trial name
- NCT05543382
- Testing
- Axonics System
- Where
- 6 sites in United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Axonics, Inc.
Spinal Cord Stimulation, Deep Brain Stimulation
Implantable Systems Performance Registry
The Implantable Systems Performance Registry (ISPR) was developed to evaluate the long-term reliability and performance of market-released Medtronic Neuromodulation infusion and stimulation products.
- Conditions
- Spinal Cord Stimulation, Deep Brain Stimulation, Drug Infusion (Implantable Pumps), Sacral Neuromodulation
- Trial name
- ISPR (NCT00959296)
- Testing
- Various
- Where
- 50 sites in United States, Austria and 5 more
- Volunteers
- 10,981 people
- Sponsor
- MedtronicNeuro
Urinary Incontinence, Over Active Bladder
Sacral Neuromodulation With InterStim® Therapy for Intractable Urinary Voiding Dysfunctions (SOUNDS): an Observational Study
The purpose of this study is to document the safety, the effectiveness, the continued performance at mid and long term, the morbidity and the percent of surgical revisions of the Interstim® therapy for up to 5 years in a…
- Conditions
- Urinary Incontinence, Over Active Bladder, Urinary Retention
- Trial name
- SOUNDS (NCT02186041)
- Testing
- Sacral Nerve Modulation
- Where
- 24 sites in France
- Volunteers
- 320 people
- Sponsor
- MedtronicNeuro
Overactive Bladder, Urinary Urgency Incontinence
Sacral Neuromodulation for Male Overactive Bladder (MOAB)
To assess the post-market clinical outcomes of the Axonics SNM System for treatment of overactive bladder in male patients.
- Conditions
- Overactive Bladder, Urinary Urgency Incontinence, Benign Prostatic Hyperplasia, Prostate Cancer
- Trial name
- NCT06511141
- Testing
- Axonics SNM System
- Where
- 23 sites in United States
- Volunteers
- 150 people
- Sponsor
- Axonics, Inc.
Urinary Urge Incontinence
Neuspera Revision Registry - Follow up Revision Experience and Evaluation of Device Outcomes Metrics
Single-arm study where subjects' responses to a questionnaire for the traditional Sacral Neuromodulation (SNM) devices will be compared to the responses regarding the Neuspera SNM System.
- Trial name
- NCT07383688
- Testing
- Neuspera Implantable Sacral Neuromodulation System
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Neuspera Medical, Inc.