Clinical trials: Sacral Neuromodulation
Fecal Incontinence
Sacral Neuromodulation as Treatment for Fecal Incontinence
The objective of this study is to investigate if low level laser therapy will do more good than harm for patients with severe refractory fecal incontinence. It is a proof of concept study without a placebo arm.
- Trial name
- LLLT-FI (NCT03825575)
- Testing
- Low level laser therapy (LLLT)
- Where
- Canada
- Volunteers
- 20 people
- Sponsor
- McMaster University
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
Low Anterior Resection Syndrome, Sacral Neuromodulation - Interstim Therapy
Effectiveness of Sacral Neuromodulation in Low Anterior Resection Syndrome
Low anterior resection syndrome (LARS) is a complex disorder suffered by patients who undergo rectal resection mainly due to rectal cancer.
- Conditions
- Low Anterior Resection Syndrome, Sacral Neuromodulation - Interstim Therapy, Rectal Cancer
- Trial name
- SANLARS (NCT03598231)
- Testing
- Sacral neuromodulation
- Where
- Spain
- Volunteers
- 45 people
- Sponsor
- Hospital Universitari Vall d'Hebron Research Institute
Overactive Bladder (OAB), Urgency Urinary Incontinence
Long-Term Effectiveness and Safety of Sacral Neuromodulation With InterStim for Lower Urinary Tract Dysfunction
This observational study will evaluate the long-term effectiveness, safety, and patient satisfaction associated with sacral neuromodulation using the InterStim™ system in adults treated for lower urinary tract dysfunction at…
- Conditions
- Overactive Bladder (OAB), Urgency Urinary Incontinence, Non-obstructive Urinary Retention, Non-obstructive Acontractile Detrusor
- Trial name
- NCT07856238
- Testing
- InterStim™ Sacral Neuromodulation System II - X
- Where
- Colombia
- Volunteers
- 1,700 people
- Sponsor
- Fundación Santa Fe de Bogota
Urge Incontinence, Urgency-frequency Syndrome
Percutaneous Nerve Evaluation Trial Time
Sacral neuromodulation (SNM) was approved by the Food and Drug Administration (FDA) for the treatment of urgency incontinence (UUI) in 1998.
- Conditions
- Urge Incontinence, Urgency-frequency Syndrome, Overactive Bladder
- Trial name
- NCT06226220
- Testing
- Sacral neuromodulation
- Where
- United States
- Volunteers
- 193 people, healthy volunteers welcome
- Sponsor
- University of Chicago
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
Interstitial Cystitis/Bladder Pain Syndrome, Underactive Bladder
SNM vs. HBOT for Refractory IC/BPS
This study is for people with long-term bladder pain and urinary problems (known as Interstitial Cystitis/Bladder Pain Syndrome or IC/BPS) that have not improved with other treatments.
- Trial name
- NCT07091266
- Testing
- Sacral Neuromodulation (SNM), Hyperbaric Oxygen Therapy (HBOT)
- Where
- China
- Volunteers
- 88 people
- Sponsor
- Shiyan City Renmin Hospital
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
Urinary Urge Incontinence
The Effects of Sacral Neuromodulation for Urinary Urgency, Frequency, and Urge Incontinence
This prospective one group cohort study seeks to investigate the effects of sacral neuromodulation on urinary urgency, frequency and urge incontinence are maintained after the simulator device is temporarily turned off for a…
- Trial name
- NCT02776475
- Testing
- Sacral neuromodulation device turned off
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- TriHealth Inc.
Overactive Bladder, Diversity
Diversity in Patients With OAB
An overactive bladder (OAB) is a condition characterized by frequent en nightly voiding, small bladder capacity and the occurrence of sudden urge to void, with or without urinary incontinence.
- Conditions
- Overactive Bladder, Diversity, Onabotulinum Toxin A, Sacral Neuromodulation
- Trial name
- DOAB (NCT05903105)
- Testing
- Questionnaires
- Where
- Belgium
- Volunteers
- 1,000 people
- Sponsor
- University Hospital, Ghent
Interstitial Cystitis
Impact Of Sacral Neuromodulation On Urine Markers For Interstitial Cystitis (IC)
Urine will be collected and sent to the University of Maryland. Urines will be analyzed for urine markers.
- Trial name
- NCT00704457
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Kenneth Peters, MD
Overactive Bladder
Combined Anticholinergic Medication and Sacral Neuromodulation to Treat Refractory Overactive Bladder
This study is a retrospective chart review including all patients who received surgical placement of a SNM device with Dr. Noblett from 2001 to the present.
- Trial name
- NCT01047046
- Testing
- Retrospective chart review
- Where
- United States
- Volunteers
- 88 people
- Sponsor
- University of California, Irvine
Bladder Hyperactivity, Sacral Neuromodulation
Evaluation of Autonomic Nervous System Changes in Response to Stimulation by Sacral Neuromodulation
Overactive bladder syndrome (OAB) is defined by urgent and frequent urges to urinate associated with frequent night-time urination and sometimes urinary incontinence.
- Trial name
- ESTIME (NCT06434831)
- Testing
- Medical device for SNM: Interstim X or Interstim micro
- Where
- France
- Volunteers
- 40 people
- Sponsor
- University Hospital, Lille
Gastrointestinal Motility Disorders in Children, Hirschsprung Disease
Improvement of Understanding of Pediatric Sacral Neuromodulation: Therapeutic Strategies and Outcome Variables
The goal of this study is to learn about the effects of sacral neuromodulation in pediatric patients with gastrointestinal motility disorders.
- Conditions
- Gastrointestinal Motility Disorders in Children, Hirschsprung Disease, Constipation - Functional
- Trial name
- SMART-GUT (NCT07519915)
- Testing
- SNM/MRI/EMG
- Where
- Germany
- Volunteers
- 25 people
- Sponsor
- Friedrich-Alexander-Universität Erlangen-Nürnberg
Overactive Bladder
Neuromodulation Implantation Settings Variation for Overactive Bladder
Participants receiving neuromodulation treatment for overactive bladder symptoms will be routinely fitted with an impulse generator.
- Trial name
- NCT02112786
- Testing
- Intermittent or Continuous Setting RestorePrime Implanted Impulse Generator
- Where
- United States
- Sponsor
- Loma Linda University
Chronic Pelvic Pain Syndrome
Sacral Neuromodulation for Chronic Pelvic Pain
Sacral neuromodulation (SNM) is a safe, effective, and minimally invasive FDA approved treatment for urinary and fecal incontinence, urinary frequency, urgency, and urinary retention.
- Trial name
- SNM_CPP (NCT06150599)
- Testing
- Sacral neuromodulation
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Corewell Health East
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.
Fecal Incontinence
Sacral Neuromodulation and Faecal Incontinence and Its Unknown Effect on the External Anal Sphincter
This innovative project aims to investigate structures and morphology of the external anal sphincter (EAS) as well as the impact of sacral neuromodulation (SNM) on the EAS morphology and biochemistry among patients with faecal…
- Trial name
- SFINX (NCT06763861)
- Testing
- Biopsy
- Where
- Sweden
- Volunteers
- 15 people
- Sponsor
- Umeå University
Chronic Pain
Analgesic Efficacy of Sacral Neuromodulation for Pelvic Cancer Pain: A Preliminary Report
in this trial, we will test the analgesic efficacy of sacral neuromodulation for patients with pelvic cancer, complaining of chronic pelvic pain in comparison to medical treatment.
- Trial name
- NCT04549818
- Testing
- sacral neuromodulation
- Volunteers
- 44 people
- Sponsor
- Assiut University
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.