The goal of this project is to show that sphincter prosthesis placement is an alternative treatment to external sphincterotomy in patients with spinal cord injury (SCI). The sphincter prosthesis consists of a surgical alloy wire mesh prosthesis inserted transurethrally under endoscopic control and is intended to hold the external sphincter open permanently. This project is designed to test the hypotheses that: 1) Sphincter prosthesis placement is as effective as external sphincterotomy for detrusor sphincter dyssynergia (DSD) based on urodynamic parameters of voiding pressure, residual urine volume, and bladder capacity. 2) Sphincter prosthesis placement has less complications than external sphincterotomy of bleeding, erectile dysfunction, autonomic dysreflexia, and reobstruction. 3) Sphincter prosthesis is associated with shorter length of surgery, shorter length of hospitalization, and reduced hospitalization costs than external sphincterotomy. Surgical alternatives to external sphincterotomy and improved treatment of DSD has not been examined in a randomized controlled manner. A total of sixty SCI patients with DSD will be entered into a prospective randomized study between stent placement and external sphincterotomy at three centers: 1) Regional Spinal Cord Injury Center of Delaware Valley (RSCICDV), Jefferson Medical College, Philadelphia, PA, 2) Ranch Los Amigos Medical Center, Downey, CA, and 3) Spinal Cord Injury Service, Department of Veterans Affairs, Palo Alto, CA. Urodynamic studies and testing will be done prior to surgery and at 1, 3, 6 and 12 months post-surgery. The protocol will provide a direct comparison of effectiveness between treatment of DSD patients with a sphincter prosthesis and transurethral sphincterotomy, the currently accepted surgical treatment. The short- term health related benefits of this project are to improve management of the dysfunctional bladder, reduce complications such as bleeding, impotence, urinary infection, multiple operations, and to reduce health care costs. The long-term benefits are to enhance the ability of subject population to more fully participate in regular life activities including school and work environment and to avoid long-term urological complications and death from renal failure and urosepsis.
| Jung, S Y; Fraser, M O; Ozawa, H et al. (1999) Urethral afferent nerve activity affects the micturition reflex;implication for the relationship between stress incontinence and detrusor instability. J Urol 162:204-12 |
| Chancellor, M B; Bennett, C; Simoneau, A R et al. (1999) Sphincteric stent versus external sphincterotomy in spinal cord injured men: prospective randomized multicenter trial. J Urol 161:1893-8 |
| Chancellor, M B; Rivas, D A; Watanabe, T et al. (1996) Reversible clinical outcome after sphincter stent removal. J Urol 155:1992-4 |
| Chancellor, M B; Rivas, D A; Abdill, C K et al. (1995) Management of sphincter dyssynergia using the sphincter stent prosthesis in chronically catheterized SCI men. J Spinal Cord Med 18:88-94 |
