Sánchez Martín R, Barrientos Fernndez G, Arrojo Vila F, Vázquez Estévez J J
Sección de Urología Pediátrica, H.G.U. Gregorio Marañón, Madrid.
An Esp Pediatr. 1999 Nov;51(5):489-92.
Ninety percent of patients with myelomeningocele are affected by urinary incontinence and more than 75% suffer fecal incontinence as well. For this reason, we carried out a clinical trial in order to demonstrate the performance of the anal plug.
The trial was carried out with 19 patients, 10 females and 9 males, between 3 and 26 years of age. Fecal incontinence was considered to be a problem in 94.7%. The anal plug used was made of polyurethane foam compressed by a polyvinyl alcohol foil that dissolves when exposed to warmth and moisture, expanding to its full size in 30-60 seconds. The anal plug is removed by pulling gently on a soft gauze string that is molded into the plug.
The maximum time of having the anal plug in place was 12 hours. The reason for removal was due to routine change in 57.9% of the cases and in 21% the product slipped out, mainly during the adaptation and training period. Application of the anal plug was found to be very easy by 73.6% of the patients. The general evaluation was excellent to good in 78.9% of the users and 89.5% of the patients wished to continue using the product.
Having clinically evaluated the effectiveness of the anal plug, we can conclude that the use of this product provides clear physical and psychological benefits. To date, it is the only non-surgical treatment for fecal incontinence available to those patients who desire to carry out a complete social life.
90%的脊髓脊膜膨出患者存在尿失禁问题，超过75%的患者还伴有大便失禁。因此，我们开展了一项临床试验，以证明肛门栓的性能。
该试验对19例患者进行，其中10例女性，9例男性，年龄在3至26岁之间。94.7%的患者认为大便失禁是个问题。所使用的肛门栓由聚氨酯泡沫制成，外面包裹着聚乙烯醇箔，当暴露于温暖和潮湿环境时，聚乙烯醇箔会溶解，肛门栓在30至60秒内膨胀至其全尺寸。通过轻轻拉动嵌入栓体的柔软纱布线即可取出肛门栓。
肛门栓放置的最长时间为12小时。取出的原因，57.9%的情况是由于常规更换，21%是因为产品滑出，主要发生在适应和训练期间。73.6%的患者认为肛门栓的应用非常容易。78.9%的使用者总体评价为优至良，89.5%的患者希望继续使用该产品。
通过对肛门栓的有效性进行临床评估，我们可以得出结论，使用该产品能带来明显的生理和心理益处。迄今为止，对于那些希望过上完整社交生活的患者来说，它是唯一可用的非手术治疗大便失禁的方法。
