Mayer R D, Dmochowski R R, Appell R A, Sand P K, Klimberg I W, Jacoby K, Graham C W, Snyder J A, Nitti V W, Winters J C
Department of Urology, University of Rochester, Strong Memorial Hospital, 601 Elmwood Avenue, Rochester, NY 14642, USA.
Urology. 2007 May;69(5):876-80. doi: 10.1016/j.urology.2007.01.050.
To evaluate the safety and effectiveness of soft-tissue augmentation of the urethral sphincter with calcium hydroxylapatite (CaHA; Coaptite) compared with glutaraldehyde cross-linked bovine collagen (Contigen) in female patients with stress urinary incontinence due to intrinsic sphincter deficiency and without associated urethral hypermobility.
This 12-month prospective, randomized, comparative, multicenter, single-blind, parallel, clinical trial of CaHA and collagen for soft-tissue augmentation of the urethral sphincter in the treatment of stress urinary incontinence enrolled 296 women. Up to five injections were performed in the first 6 months of the trial. Twelve-month postinjection efficacy data were available for 231 patients.
The results indicated that CaHA and collagen were both well tolerated in this study. No systemic adverse events were observed with either product. We used the Stamey Urinary Incontinence Scale to grade the improvement, which was the primary endpoint of the study. At 12 months, 83 (63.4%) of 131 CaHA patients compared with 57 (57.0%) of 100 collagen patients showed improvement of one Stamey grade or more (P = 0.34). More CaHA patients required only one injection (n = 60; 38.0%) during the study compared with the Contigen patients (n = 36; 26.1%; P = 0.034). Also, the average total volume of material injected during the course of the study was less for CaHA than for collagen (4.0 mL versus 6.6 mL, respectively; P <0.0001).
The results of the study have demonstrated that Coaptite is an appropriate and well-tolerated treatment for patients with incontinence due to intrinsic sphincter deficiency. This new soft-tissue augmentation material has a good safety profile and appears to provide durable improvement.
比较羟基磷灰石钙（CaHA；Coaptite）与戊二醛交联牛胶原蛋白（Contigen）对因内在括约肌缺陷且无尿道活动过度相关的女性压力性尿失禁患者进行尿道括约肌软组织填充的安全性和有效性。
这项为期12个月的前瞻性、随机、对照、多中心、单盲、平行临床试验，纳入296名女性，使用CaHA和胶原蛋白进行尿道括约肌软组织填充以治疗压力性尿失禁。在试验的前6个月内最多进行5次注射。231名患者有12个月的注射后疗效数据。
结果表明，在本研究中CaHA和胶原蛋白的耐受性均良好。两种产品均未观察到全身性不良事件。我们使用Stamey尿失禁量表对改善情况进行分级，这是该研究的主要终点。12个月时，131名CaHA患者中有83名（63.4%）较100名胶原蛋白患者中的57名（57.0%）改善了一个或更多Stamey等级（P = 0.34）。与Contigen患者（n = 36；26.1%；P = 0.034）相比，更多CaHA患者在研究期间仅需一次注射（n = 60；38.0%）。此外，研究过程中CaHA注射材料的平均总体积比胶原蛋白少（分别为4.0 mL对6.6 mL；P <0.0001）。
该研究结果表明，Coaptite是治疗因内在括约肌缺陷导致尿失禁患者的一种合适且耐受性良好的治疗方法。这种新型软组织填充材料具有良好的安全性，似乎能提供持久的改善效果。
