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.
Rheumatoid Arthritis
Sacral Nerve Stimulation for Mild-to-Moderate or Refractory Rheumatoid Arthritis
This pilot study will assess the efficacy of sacral never stimulation (SNS) for the treatment of adult patients with active, mild-to-moderate rheumatoid arthritis or those with refractory disease.
- Trial name
- NCT04821050
- Testing
- Sacral nerve stimulation
- Where
- China
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Nanjing First Hospital, Nanjing Medical University
Spinal Cord Injuries (SCI), Detrusor Overactivity
The Effectiveness of Transcutaneous Sacral Neuromodulation Techniques-Magnetic Stimulation and Electrical Stimulation-on Detrusor Overactivity in Patients With Spinal Cord Injury
The goal of this prospective, randomized clinical trial is to compare the efficacy and safety of transcutaneous sacral magnetic stimulation versus sacral electrical stimulation for detrusor overactivity in 40 male and female…
- Trial name
- NCT07578532
- Testing
- Transcutaneous Sacral Electrical Stimulation, Transcutaneous sacral magnetic stimulation
- Where
- Turkey (Türkiye)
- Volunteers
- 40 people
- Sponsor
- Ankara City Hospital Bilkent
Overactive Bladder
Predictive Utility and Mechanisms of Sacral Evoked Responses in Sacral Neuromodulation
Electrical stimulation of the sacral nerve can help with bladder problems and pelvic pain but researchers don't understand exactly how the stimulation helps.
- Trial name
- NCT06983470
- Testing
- SNM based on visual-motor responses (VMRs), SNM based on sacral evoked responses (SERs)
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- University of Michigan
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
Low Anterior Resection Syndrome (LARS)
Early Implementation of Sacral Neuromodulation in Patients With Low Anterior Resection Syndrome.
A randomized, prospective, multicenter, open-label, pragmatic pilot study of patients with Low Anterior Resection Syndrome treated early (<120 days after discharge following intestinal bypass reconstruction) with sacral nerve…
- Trial name
- NCT07761884
- Testing
- Sacral neuromodulation
- Where
- Spain
- Volunteers
- 40 people
- Sponsor
- Hospital Universitari Vall d'Hebron Research Institute
Overactive Bladder, Non Obstructive Urinary Retention
Sacral Neuromodulation and Pudendal Somatic Afferents
Sacral neuromodulation is a well-excepted minimally invasive procedure for the treatment of overactive bladder and non-obstructive urinary retention.A tined lead with 4 stimulation electrodes is placed through the third or fourth…
- Trial name
- NCT03614754
- Testing
- Somatosensory evoked potentials
- Where
- Belgium
- Volunteers
- 40 people
- Sponsor
- Universiteit Antwerpen
Active Ulcerative Colitis
Evaluation of Sacral Neuromodulation (SNM) in the Treatment of Active Ulcerative Colitis (PRIMICISTIM)
Efficacy of ulcerative colitis to induce remission in patients with moderate to severe active ulcerative colitis.
- Trial name
- PRIMICISTIM (NCT02748590)
- Testing
- InterStim II Neurostimulator Model 3058
- Where
- France
- Volunteers
- 8 people
- Sponsor
- Nantes University Hospital
Urgency Urinary Incontinence
Sacral Neuromodulation and the Microbiome
Sacral neuromodulation (SNM) which is approved as a treatment for men and women with urgency urinary incontinence (UUI), urgency frequency syndrome, urinary retention and anal incontinence, is a procedure designed to deliver…
- Trial name
- NCT02833402
- Testing
- InterStim Therapy
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Northwestern University
Spinal Cord Injury, Acute, Neurogenic Bladder
Sacral Nerve Stimulation in Improving Bladder Function After Acute Traumatic Spinal Cord Injury
The purpose of this study is to see what effects sacral neuromodulation has on bladder function and quality of life in patients with acute spinal cord injury.
- Conditions
- Spinal Cord Injury, Acute, Neurogenic Bladder, Incontinence, Urinary Tract Infections
- Trial name
- NCT03083366
- Testing
- PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN)
- Where
- 2 sites in United States
- Volunteers
- 5 people
- Sponsor
- University of Utah
Low Anterior Resection Syndrome
Pathway of Low Anterior Resection Syndrome Relief After Surgery: a Feasibility Study
Currently, no standard exists for the treatment and management of Low Anterior Resection Syndrome (LARS)- a common disorder that affects patients who have had part of their bowel removed due to colorectal cancer.
- Trial name
- POLARiS (NCT05319054)
- Testing
- Sacral NeuroModulation, Trans-Anal Irrigation, Optimised Conservative Management
- Where
- 4 sites in United Kingdom
- Volunteers
- 187 people
- Sponsor
- Cardiff and Vale University Health Board
Acontractile Bladder
Ambulatory Urodynamic Evaluation of Sacral Neuromodulation for Non-Obstructive Urinary Retention
Ambulatory Urodynamic measurement on patients with diminished or absent bladder contractility before and after trial with Sacral Neuromodulation therapy.
- Trial name
- NCT00970242
- Where
- Netherlands
- Volunteers
- 25 people
- Sponsor
- Maastricht University Medical Center
Neurogenic Dysfunction of the Urinary Bladder, Multiple Sclerosis
Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction
A multi-center double-blinded placebo-controlled randomized clinical trial. The patients will be randomized into two groups. To investigate the efficacy of SNM to improve the key bladder diary variables compared to placebo (i.e.
- Conditions
- Neurogenic Dysfunction of the Urinary Bladder, Multiple Sclerosis, Sacral Neuromodulation, Bowel Dysfunction
- Trial name
- NCT05380856
- Testing
- Turning ON the neuromodulator, Turning OFF the neuromodulator
- Where
- Denmark
- Volunteers
- 60 people
- Sponsor
- Odense University Hospital
Normal Subjects, Fecal Incontinence
Trial to Evaluate Fecobionics in Healthy Subjects and Patients
Fecobionics combines several existing tests to provide novel insight into anorectal function. The purpose for the development was to overcome the technological controversies and disagreement between various tests and…
- Trial name
- NORMAL (NCT04766138)
- Testing
- Fecobionics
- Where
- United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- The California Medical Innovations Institute, Inc.
Refractory Overactive Bladder
Vaginal Electrical Stimulation Versus Neuromodulation
This prospective study compares quality of life measures of patients with refractory overactive bladder, between two modes of neuromodulation: vaginal electrical stimulation (Group A) and sacral nerve stimulation (Group B).
- Trial name
- Estim (NCT01525485)
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- University of Oklahoma
Urinary Tract Disease
Brain Effects of Sacral Neuromodulation
Sacral neuromodulation (SNM) has become an accepted treatment for patients with refractory lower urinary tract dysfunction such as urgency frequency syndrome, urgency incontinence, non-obstructive chronic urinary retention and…
- Trial name
- NCT00610064
- Testing
- Baseline neuroimaging, Neuroimaging during sacral neuromodulation
- Where
- Switzerland
- Volunteers
- 30 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
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.
Fecal Incontinence
Improving the Efficacy of Sacral Nerve Stimulation for Fecal Incontinence by Alteration of Stimulation Parameters
Faecal incontinence is a devastating condition affecting 2,2 to 5 % of the adult population. The magnitude of the problem is probably underestimated.
- Trial name
- NCT01254695
- Testing
- Medtronic InterStim / InterStim II
- Where
- 2 sites in Denmark, United Kingdom
- Volunteers
- 15 people
- Sponsor
- University of Aarhus