title: The genitourinary spheroidal membrane: an experimental study of a new percutaneously inserted prosthetic device for the control of urinary incontinence.
abstract: The genitourinary spheroidal membrane, composed of silicone rubber, has been developed along with a mechanical delivery instrument that allows transcutaneous insertion of the prosthetic sphere in the periurethral tissues to enhance outlet resistance in incontinent patients. An experimental study was undertaken in six female mongrel dogs to evaluate the safety and efficacy of this concept. The leak-point pressure increased from five to 38 cm. H2O (mean increase, 16.8 cm. H2O). This increase is statistically significant (p less than 0.024, two-sided t test). During the 90-day experiment, there was no migration of the spheres, minimal local inflammatory response, and no granuloma formation or inflammatory response in various organs studied. Although the leak-point pressure was increased in all of the dogs, none developed difficulty voiding. We conclude that the design concept is sound and safe, the delivery system is reliable, and it is possible to place the spheroidal membrane into an anatomic location that will increase outlet resistance.
authors.affiliation: Department of Urology, Mayo Clinic, Rochester, Minnesota.
authors.forename: D M
authors.initials: DM
authors.lastname: Barrett
authors.forename: B G
authors.initials: BG
authors.lastname: Parulkar
authors.forename: A A
authors.initials: AA
authors.lastname: Malizia
mesh_terms: D000818:Animals; D004285:Dogs; D005069:Evaluation Studies as Topic; D005260:Female; D008422:Materials Testing; D008567:Membranes, Artificial; D019736:Prostheses and Implants / Q000009:adverse effects; D011474:Prosthesis Design; D012826:Silicone Elastomers / Q000633:toxicity; D014521:Urethra / Q000503:physiopathology; D014549:Urinary Incontinence / Q000503:physiopathology / Q000517:prevention & control*; D014563:Urodynamics / Q000502:physiology
chemical_list: D008567:Membranes, Artificial; D012826:Silicone Elastomers