Barrett D M, Parulkar B G, Malizia A A
Department of Urology, Mayo Clinic, Rochester, Minnesota.
J Urol. 1989 Dec;142(6):1615-8. doi: 10.1016/s0022-5347(17)39179-6.
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.
由硅橡胶制成的泌尿生殖球形膜已与一种机械输送器械一同研发出来，该器械可经皮将假体球插入尿道周围组织，以增强尿失禁患者的出口阻力。在六只雌性杂种犬身上进行了一项实验研究，以评估这一概念的安全性和有效性。漏点压力从5厘米水柱增加到38厘米水柱（平均增加16.8厘米水柱）。这种增加具有统计学意义（p<0.024，双侧t检验）。在为期90天的实验中，球体没有移位，局部炎症反应极小，在所研究的各个器官中均未形成肉芽肿或炎症反应。尽管所有犬的漏点压力都有所增加，但没有一只出现排尿困难。我们得出结论，该设计理念合理且安全，输送系统可靠，并且有可能将球形膜放置在能增加出口阻力的解剖位置。
