Clinical trials: Sacral Disorder
Constipation, Fecal Incontinence
Long Term Efficacy of Sacral Nerve Modulation (SNM) in Patients With Constipation or Stool Incontinence
The aim of this study is to determine the success rate, the success duration, the complication rate, maintenance effort and quality of life several years after sacral nerve modulation (SNM) treatment for constipation or stool…
- Trial name
- NCT02836717
- Testing
- sacral nerve modulation
- Volunteers
- 101 people
- Sponsor
- Cantonal Hospital of St. Gallen
Breast Cancer, Head and Neck Cancer
A Phase 1/2 Safety Study of Intratumorally Dosed INT230-6
This study evaluated the intratumoral administration of escalating doses of a novel, experimental drug, INT230-6. The study was conducted in patients with several types of refractory cancers including those at the surface of the…
- Conditions
- Breast Cancer, Head and Neck Cancer, Squamous Cell Carcinoma, Lymphoma
- Trial name
- IT-01 (NCT03058289)
- Testing
- INT230-6, anti-PD-1 antibody, anti-CTLA-4 antibody
- Where
- 8 sites in United States, Canada
- Volunteers
- 111 people
- Sponsor
- Intensity Therapeutics, Inc.
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.
Pressure Ulcers
Wound Management for Sacral Pressure Ulcers With Necrotic Tissue
Evaluation of a wound care debridement product and a moisturizer on sacral pressure ulcer wounds
- Trial name
- NCT02224638
- Testing
- TheraHoney HD, SkinTegrity
- Where
- 2 sites in United States
- Volunteers
- 21 people
- Sponsor
- Medline Industries
Urinary Incontinence, Urge
Refractory Overactive Bladder: Sacral NEuromodulation v. BoTulinum Toxin Assessment (ROSETTA)
The purpose of this randomized, open-label, active-control trial is to compare the effectiveness of intra-detrusor botulinum toxin A (Botox A®, Allergan) versus sacral neuromodulation (InterStim®, Medtronic) for the treatment of…
- Trial name
- ROSETTA (NCT01502956)
- Testing
- InterStim® device, Botox® injection
- Where
- 9 sites in United States
- Volunteers
- 386 people
- Sponsor
- NICHD Pelvic Floor Disorders Network
Urinary Incontinence, Urge
Cycling Versus Continuous Mode in Neuromodulator Programming
The investigators objective is to compare patient outcomes as changes in validated symptom measures of overactive bladder, the Overactive Bladder Questionnaire Short Form (OABq-SF) symptom scale, between women who are set on…
- Trial name
- NCT02551822
- Testing
- sacral neuromodulator
- Where
- 2 sites in United States
- Volunteers
- 32 people
- Sponsor
- University of New Mexico
Low Anterior Resection Syndrome, Malignant Anal Neoplasm
Sacral Nerve Stimulation in Treating Low Anterior Resection Syndrome or Fecal Incontinence in Patients With Locally Advanced Rectal Cancer or Other Pelvic Cancer, the RESTORE Study
This phase II trial studies how well sacral nerve stimulation works in treating low anterior resection syndrome or fecal incontinence (the body's passage of stool without control) in patients with rectal cancer that has spread to…
- Conditions
- Low Anterior Resection Syndrome, Malignant Anal Neoplasm, Malignant Bladder Neoplasm, Malignant Cervical Neoplasm
- Trial name
- NCT04066894
- Testing
- Explantation, Quality-of-Life Assessment, Questionnaire Administration
- Where
- 2 sites in United States
- Volunteers
- 3 people
- Sponsor
- M.D. Anderson Cancer Center
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
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.
Hip Fracture, Pressure Ulcer
Polyurethane Foam on the Sacrum for Prevention
The aim of the present study is to assess whether the application of a new hydrocellular polyurethane foam multilayer dressing shaped for the sacral area (MSP) in addition to standard care reduces the rate of pressure sores (PU)…
- Trial name
- NCT02692482
- Testing
- hydrocellular polyurethane foam multilayer dressing, standard care
- Where
- Italy
- Volunteers
- 359 people
- Sponsor
- Istituto Ortopedico Rizzoli
Spinal Cord Injury
High Frequency SARS for Neurogenic Bladder and Bowel Emptying
The purpose of this study is to determine if bladder emptying can be achieved using stimulation of the sacral roots at certain frequencies. Neurogenic bladder dysfunction occurs after spinal cord injury (SCI).
- Trial name
- SARS600 (NCT05214378)
- Testing
- Finetech-Brindley Sacral Anterior Roots Stimulation System
- Where
- 2 sites in United States
- Volunteers
- 4 people
- Sponsor
- VA Office of Research and Development
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
Pressure Ulcer
Effectiveness of Two Silicone Dressings for Sacral and Heel Pressure Ulcer Prevention
The aim of this randomized controlled trial is to test the efficacy of preventive dressings for pressure ulcer prevention.
- Trial name
- NCT02295735
- Testing
- Mepilex® Border Sacrum and Mepilex® Border Heel
- Where
- Germany
- Volunteers
- 475 people
- Sponsor
- PD Dr. Jan Kottner
Rectal Cancer, for Bowel Dysfunction Following Surgery for Rectal Cancers
Sacral Neuromodulation (SNM) With InterStimTM for Bowel Dysfunction Following Surgery for Rectal Cancers With Sphincter Preservation
The purpose of this study is to evaluate whether a medical device/implant (InterStimTM) will help patients to have more normal bowel movements. The InterStimTM device is a neuromodulating device.
- Trial name
- NCT02163187
- Testing
- Implantation of the InterStimTM, MSK BFI questionnaires, The Low Anterior Resection Score (LARS) questionnaires
- Where
- 2 sites in United States
- Volunteers
- 4 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Urinary Urge Incontinence
InterStim® Sacral Nerve Modulation Cycling Study
The study will assess the effects of different InterStim cycling settings on urinary urge incontinence.
- Trial name
- NCT01957137
- Testing
- InterStim® (Device Programming)
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- MedtronicNeuro
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
Fecal Incontinence
Sacral Nerve Stimulation Therapy for the Treatment of Chronic Fecal Incontinence
Fecal incontinence (FI) is a difficulty in storing gas, liquid stool or solid stool (bowel movement) in order to expel it at a proper time and place.
- Trial name
- NCT00200057
- Testing
- InterStim Sacral Nerve Stimulation Therapy
- Where
- 13 sites in United States, Canada
- Volunteers
- 285 people, healthy volunteers welcome
- Sponsor
- MedtronicNeuro
Dual Incontinence, Fecal Incontinence
Sacral Neuromodulation in Dual Incontinence: Ultrasound and Afferent Nerve Sensation Assessment
Women with Dual Incontinence (DI) (both Urinary Incontinence (UI) and Fecal Incontinence (FI)) often have more bothersome symptoms, quality of life impact, and sexual dysfunction than those with just UI or FI.
- Conditions
- Dual Incontinence, Fecal Incontinence, Urinary Incontinence, Sacral Neuromodulation
- Trial name
- SaNDI (NCT02357784)
- Testing
- Neurometer
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Northwestern University
Visceral Prolapse
Apical Suspension Repair for Vault Prolapse In a Three-Arm Randomized Trial Design
The study is a multi-center, randomized, surgical trial of women with symptomatic post-hysterectomy apical (cuff) prolapse desiring surgical treatment.
- Trial name
- ASPIRe (NCT02676973)
- Testing
- Open, Robotic, or Laparoscopic, Transvaginal Native Tissue Repair, Uphold™ LITE
- Where
- 10 sites in United States
- Volunteers
- 360 people
- Sponsor
- NICHD Pelvic Floor Disorders Network
Pressure Ulcers
Effects of Different Support Surfaces on the Properties Skin After Loading
Pressure ulcers are severe injuries and wounds causing a substantial burden on patients, caregivers, and on healthcare systems worldwide.
- Trial name
- NCT02930590
- Testing
- Alternating low pressure mattress with air loss function, Gel mattress, Basic foam
- Where
- Germany
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Charite University, Berlin, Germany