Clinical trials: Sacral Disorder
Fecal Incontinence, Bowel Incontinence
Fecal Incontinence Treatment (FIT) Study
Patients with severe fecal incontinence (FI), defined as two or more episodes of staining, solid or liquid FI per week, and who meet the inclusion criteria for Injection of Solesta (INJ; an inert bulking agent), or Biofeedback…
- Trial name
- NCT03811821
- Testing
- Biofeedback, Injection
- Where
- 6 sites in United States
- Volunteers
- 275 people
- Sponsor
- Mayo Clinic
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
Spinal Cord Injuries
Combined Magnetic Stimulation and Ultrasound for Detrusor Overactivity in SCI
This clinical trial aims to investigate whether the combination of high-frequency sacral nerve root magnetic stimulation and bladder-directed ultrasound therapy can effectively improve detrusor overactivity (involuntary bladder…
- Trial name
- NCT07704268
- Testing
- Transcranial Magnetic Stimulation (TMS) Device /Ultrasound therapy device
- Where
- China
- Volunteers
- 44 people
- Sponsor
- Shengjing Hospital
Faecal Incontinence
Computational Model of SNS (Sacral Nerve Stimulation) Induced Electrical Current Flow Using Tractography Imaging
This study aims to obtain finer details of tissues surrounding a lead in the pelvis using a combination of high-resolution anatomical MRI sequences and diffusion tensor imaging (DTI).
- Trial name
- NCT05049486
- Testing
- CT scan
- Where
- United Kingdom
- Volunteers
- 10 people
- Sponsor
- London North West Healthcare NHS Trust
Overactive Bladder
Clinical and Urodynamic Predictors for Sacral Neuromodulation Outcomes in Overactive Bladder
Overactive bladder syndrome (OAB) is a prevalent disorder that affects about 10% of the adult population and > 40% of elderly. It is defined by the presence of urgency, with or without urge incontinence, in the absence of…
- Trial name
- NCT03156088
- Testing
- Sacral Neuromodulator "InterStim"
- Volunteers
- 100 people
- Sponsor
- Assiut 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
Analgesia, Pain, Acute
Assessment of Efficacy of Sacral Erector Spinae Plane Block for Postoperative Analgesia in Pediatric Rectal Biopsies
The purpose of this study is to evaluate how sacral erector spinae block changed the postoperative analgesia requirements in pediatric patients undergoing rectal biopsies under general anesthesia.
- Trial name
- NCT06362811
- Testing
- Sacral Erector Spinae Plane Block
- Where
- Turkey (Türkiye)
- Volunteers
- 48 people
- Sponsor
- Istanbul University
Spondylolisthesis
Posterior Lateral Fusion (PLF) With Dynesys
The primary purpose of this study is to track and document the clinical outcomes of patients with radicular pathology following posterior lateral fusion with the Dynesys Spinal System.
- Trial name
- NCT00791180
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- Zimmer Biomet
Pelvic Organ Prolapse, Cystocele
Laparoscopic Three-dimensional Versus Two-dimensional Sacral Colpopexy and Paravaginal Repair
Compare operative times and complications of sacral colpopexy and paravaginal repair between two-dimensional and three-dimensional laparoscopic systems.
- Trial name
- NCT02258230
- Testing
- 3D mode of the 3D Laparoscopic Video System, 2D mode of the 3D Laparoscopic Video System
- Where
- 2 sites in United States
- Volunteers
- 194 people
- Sponsor
- Olympus Corporation of the Americas
Radiation Exposure, Overactive Bladder
Fluoroscopy Radiation Reduction During Sacral Neuromodulation Lead Placement
Fluoroscopy is performed when placing a lead during a sacral neuromodulation procedure. During lead placement, subjects will receive either conventional or experimental fluoroscopic settings.
- Conditions
- Radiation Exposure, Overactive Bladder, Urge Incontinence, Urgency-frequency Syndrome
- Trial name
- NCT04527445
- Testing
- Reduced radiation fluoroscopy, Conventional fluoroscopy
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- Loma Linda University
Healthy Volunteer, Pressure Distribution
Comparison of Sacral Interface Pressure in Healthy Volunteers on Two Dynamic Pressure-Prevention Support Surfaces
The purpose of the research study is to investigate the peak sacral interface pressures of two separate hospital bed systems in the supine and 30 degrees head-of-bed elevation position.
- Trial name
- NCT06661954
- Testing
- Bed A - Head of Bed 0 degrees, Bed B - Head of Bed 0 degrees, Bed A - Head of bed at 30 degrees
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
Physical Therapy Modalities
Effects of Physical Therapy Associated With Photobiomodulation on Myelomeningocele
Myelomeningocele is a severe type of spina bifida, resulting from improper closure of the neural tube. This condition drastically affects the structures of the spinal cord, as a result the spinal cord, nerve roots and meninges…
- Trial name
- NCT04425330
- Testing
- physiotherapy exercises, PBM
- Volunteers
- 30 people
- Sponsor
- University of Nove de Julho
Degeneration Spine
Primary Sacroiliac Fusion Versus Fusion to the Sacrum for Degenerative Disease of the Lumbar Spine
To prove that the use of additional S2alar-iliac screws for pure lumbar fusions due to degenerative lumbar disease provides superior outcome compared to the standard procedure of fusion to S1.
- Trial name
- PSEUDOLUSE (NCT04308018)
- Testing
- S2alar-iliac screws, S1 screws
- Volunteers
- 148 people
- Sponsor
- Technical University of Munich
Paralytic Scoliosis, Pelvic Obliquity
Posterior Minimally Invasive Surgery for Treating Paralytic Scoliosis With Pelvic Obliquity in Children Following Spinal Cord Injury
This randomized controlled trial compares posterior minimally invasive correction surgery with conventional posterior spinal fusion for children with paralytic scoliosis and severe pelvic obliquity following spinal cord injury.
- Conditions
- Paralytic Scoliosis, Pelvic Obliquity, Spinal Cord Injury, Neuromuscular Scoliosis
- Trial name
- NCT07594574
- Testing
- Posterior Minimally Invasive Correction Surgery, Conventional Posterior Spinal Fusion
- Where
- China
- Volunteers
- 39 people
- Sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
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
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 Bladder, Overactive
Unilateral Versus Bilateral Neuromodulation Tests in the Treatment of Refractory Idiopathic Overactive Bladder
The primary objective of this study is to compare the efficacy of unilateral and bilateral neuromodulation tests at 1 month.
- Trial name
- HAVIR Bi (NCT01558856)
- Testing
- Unilateral electrode placement and testing, Bilateral electrode placement and testing
- Where
- 6 sites in France
- Volunteers
- 55 people
- Sponsor
- Centre Hospitalier Universitaire de Nīmes
Overactive Bladder, Non Obstructive Urinary Retention
Time of Effect Onset in Treating Overactive Bladder or Non Obstructive Urinary Retention by Sacral Neuromodulation
Sacral neuromodulation (SNM) is a minimally invasive secondary treatment for overactive bladder syndrome (OAB) or for non-obstructive urinary retention (NOR), when refractory to conservative treatment.
- Trial name
- NCT02040519
- Testing
- Filling out voiding diaries.
- Where
- Netherlands
- Volunteers
- 45 people
- Sponsor
- Maastricht University Medical Center
Vaginal Prolapse
0050-19-RMB CTIL - VNOTES Compared to VH for Vaginal Apex Prolapse
VNOTES (Transvaginal natural orifice transluminal endoscopic surgery) is a relatively new surgery for Hysterectomy and Uterosacral ligament suspension to treat Vaginal prolapse.
- Trial name
- NCT04078802
- Testing
- VNOTES/VH
- Volunteers
- 60 people
- Sponsor
- Rambam Health Care Campus
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.