Altman Daniel, Hjern Fredrik, Zetterström Jan
Stockholm Urogynecological Clinic, Stockholm, Sweden.
Department of Clinical Sciences, Karolinska Institute Danderyd Hospital, Danderyd, Sweden.
Acta Obstet Gynecol Scand. 2016 May;95(5):528-33. doi: 10.1111/aogs.12866. Epub 2016 Mar 14.
The efficacious and safe use of transurethral injections of polyacrylamide hydrogel (Bulkamid(®)) in women with stress urinary incontinence suggests that it may be suitable also for treatment of anal incontinence. We aimed to determine the effectiveness and safety of polyacrylamide hydrogel when used as a transanal submucosal bulking agent in women with anal incontinence.
Thirty women with a diagnosis of anal incontinence and a Cleveland Clinic Incontinence Score (CCIS) >10 were randomized to three different techniques of transanal submucosal injections using polyacrylamide hydrogel. Follow up was performed at 2, 6 and 12 months using CCIS and the Fecal Incontinence Quality of Life scale (FIQL).
In all, 29 of the 30 women completed the follow up. Approximately half of the women requested a re-injection at the 6-month visit. The overall CCIS improved significantly from baseline (14.7. SD 2.5) to 1 year (12.4. SD 3.1) (p = 0.003). There was a significant improvement with regard to the occurrence of loose fecal incontinence (p = 0.014) but not for solid fecal incontinence (p = 0.28). At 1 year the FIQL domains of coping-behavior, depression, and embarrassment showed significant improvements (p = 0.012, p = 0.007 and p = 0.007, respectively). We recorded no adverse events related either to the injection technique or the biomaterial. There were no significant differences between the treatment groups in either CCIS or FIQL scores.
Transanal submucosal injection of polyacrylamide hydrogel resulted in a modest although significant overall improvement in anal incontinence symptom scores with corresponding improvements in several domains of quality of life, regardless of injection volume.
经尿道注射聚丙烯酰胺水凝胶（Bulkamid®）治疗女性压力性尿失禁有效且安全，这表明其可能也适用于治疗肛门失禁。我们旨在确定聚丙烯酰胺水凝胶作为经肛门黏膜下填充剂用于治疗女性肛门失禁时的有效性和安全性。
30名诊断为肛门失禁且克利夫兰诊所失禁评分（CCIS）>10的女性被随机分为三组，采用不同技术经肛门黏膜下注射聚丙烯酰胺水凝胶。在2个月、6个月和12个月时使用CCIS和大便失禁生活质量量表（FIQL）进行随访。
30名女性中共有29名完成了随访。约一半的女性在6个月随访时要求再次注射。总体CCIS从基线时的（14.7，标准差2.5）显著改善至1年时的（12.4，标准差3.1）（p = 0.003）。在稀便失禁的发生率方面有显著改善（p = 0.014），但在固体大便失禁方面无改善（p = 0.28）。1年时，FIQL量表中应对行为、抑郁和尴尬等领域有显著改善（分别为p = 0.012、p = 0.007和p = 0.007）。我们未记录到与注射技术或生物材料相关的不良事件。治疗组在CCIS或FIQL评分方面无显著差异。
经肛门黏膜下注射聚丙烯酰胺水凝胶使肛门失禁症状评分总体虽有适度但显著的改善，同时生活质量的几个领域也相应得到改善，且与注射量无关。
