Dennis J Bourbeau1,2,3, Kenneth J Gustafson1,3,4, Steven W Brose1,3,5,6. 1. a Louis Stokes Cleveland Department of Veterans Affairs Medical Center , Cleveland Ohio. 2. b Department of Physical Medicine and Rehabilitation , MetroHealth Medical Center , Cleveland , Ohio. 3. c Cleveland VA Functional Electrical Stimulation Center , Cleveland , Ohio. 4. d Departments of Biomedical Engineering and Urology , Case Western Reserve University , Cleveland , Ohio. 5. e Department of Physical Medicine & Rehabilitation , Case Western Reserve University , Cleveland , Ohio. 6. f Heritage College of Osteopathic Medicine, Ohio University, Athens, Ohio.
Abstract
OBJECTIVE: Neurogenic bladder dysfunction, including neurogenic detrusor overactivity (NDO) is one of the most clinically significant problems for persons with spinal cord injury (SCI), affecting health and quality of life. Genital nerve stimulation (GNS) can acutely inhibit NDO-related reflex bladder contractions and increase bladder capacity. However, it is unknown if GNS can improve urinary continence or help meet individuals' bladder management goals during sustained use, which is required for GNS to be clinically effective. DESIGN: Subjects maintained voiding diaries during a one-month control period without stimulation, one month with at-home GNS, and one month after GNS. Urodynamics and quality of life assessments were conducted after each treatment period, and a satisfaction survey was taken at study completion. SETTING: Subject screening and clinical procedures were conducted at the Louis Stokes Cleveland VA Medical Center. Stimulation use and voiding diary entries were conducted in subjects' homes. PARTICIPANTS: Subjects included five men with SCI and NDO. INTERVENTIONS: This study tested one month of at-home portable non-invasive GNS. OUTCOME MEASURES: The primary outcome measure was leakage events per day. Secondary outcome measures included self-reported subject satisfaction, bladder capacity, and stimulator use frequency. RESULTS: GNS reduced the number of leakage events from 1.0 ± 0.5 to 0.1 ± 0.4 leaks per day in the four subjects who reported incontinence data. All study participants were satisfied that GNS met their bladder goals; wanted to continue using GNS; and would recommend it to others. CONCLUSIONS: Short term at-home GNS reduced urinary incontinence and helped subjects meet their bladder management goals. These data inform the design of a long-term clinical trial testing of GNS as an approach to reduce NDO.
OBJECTIVE:Neurogenic bladder dysfunction, including neurogenic detrusor overactivity (NDO) is one of the most clinically significant problems for persons with spinal cord injury (SCI), affecting health and quality of life. Genital nerve stimulation (GNS) can acutely inhibit NDO-related reflex bladder contractions and increase bladder capacity. However, it is unknown if GNS can improve urinary continence or help meet individuals' bladder management goals during sustained use, which is required for GNS to be clinically effective. DESIGN: Subjects maintained voiding diaries during a one-month control period without stimulation, one month with at-home GNS, and one month after GNS. Urodynamics and quality of life assessments were conducted after each treatment period, and a satisfaction survey was taken at study completion. SETTING: Subject screening and clinical procedures were conducted at the Louis Stokes Cleveland VA Medical Center. Stimulation use and voiding diary entries were conducted in subjects' homes. PARTICIPANTS: Subjects included five men with SCI and NDO. INTERVENTIONS: This study tested one month of at-home portable non-invasive GNS. OUTCOME MEASURES: The primary outcome measure was leakage events per day. Secondary outcome measures included self-reported subject satisfaction, bladder capacity, and stimulator use frequency. RESULTS: GNS reduced the number of leakage events from 1.0 ± 0.5 to 0.1 ± 0.4 leaks per day in the four subjects who reported incontinence data. All study participants were satisfied that GNS met their bladder goals; wanted to continue using GNS; and would recommend it to others. CONCLUSIONS: Short term at-home GNS reduced urinary incontinence and helped subjects meet their bladder management goals. These data inform the design of a long-term clinical trial testing of GNS as an approach to reduce NDO.
Authors: April N Herrity; Sevda C Aslan; Samineh Mesbah; Ricardo Siu; Karthik Kalvakuri; Beatrice Ugiliweneza; Ahmad Mohamed; Charles H Hubscher; Susan J Harkema Journal: Sci Rep Date: 2022-07-01 Impact factor: 4.996
Authors: Steve J A Majerus; Sarah J Offutt; Thaddeus S Brink; Vincent Vasoli; Ian Mcadams; Margot S Damaser; Lance Zirpel Journal: IEEE Trans Neural Syst Rehabil Eng Date: 2021-10-13 Impact factor: 4.528
Authors: Dennis Bourbeau; Abby Bolon; Graham Creasey; Wei Dai; Bill Fertig; Jennifer French; Tara Jeji; Anita Kaiser; Roman Kouznetsov; Alexander Rabchevsky; Bruno Gallo Santacruz; Jiayang Sun; Karl B Thor; Tracey Wheeler; Jane Wierbicky Journal: Spinal Cord Date: 2020-09-07 Impact factor: 2.772