{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,12]],"date-time":"2026-05-12T23:41:06Z","timestamp":1778629266445,"version":"3.51.4"},"reference-count":26,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2007,2,19]],"date-time":"2007-02-19T00:00:00Z","timestamp":1171843200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Aliment Pharmacol Ther"],"published-print":{"date-parts":[[2007,5]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p><jats:bold>Aim<\/jats:bold> To test efficacy and safety of polydimethylsiloxane elastomer implants, a silicone biomaterial, in patients with severe faecal incontinence related to an impaired internal anal sphincter.<\/jats:p><jats:p><jats:bold>Methods<\/jats:bold> Subjects were randomized to receive three injections of 2.5\u2003mL of either physiological saline or polydimethylsiloxane elastomer. After local anaesthesia, an 18\u2003gauge, 2.5\u2010in needle was inserted through the perianal skin and laid down into the intersphincteric space. Treatment (saline or polydimethylsiloxane elastomer) was administered by means of a ratchet gun. Three injections of 2.5\u2003mL each were performed in the area of the internal anal sphincter at 3, 7 and 11\u2003o\u2019clock positions. Main end point was the percentage of subjects in each treatment arm experiencing a successful treatment, defined as a Cleveland Clinic Florida\u2010Faecal Incontinence score &lt;8, 3\u2003months after treatment. Secondary end points were quality of life scores, weekly number of faecal incontinence episodes, subject acceptance and adverse events rate. Both patients and end point assessments were blinded to treatment.<\/jats:p><jats:p><jats:bold>Results<\/jats:bold> 44 women (64.3\u2003\u00b1\u20039\u2003years) with a baseline Cleveland Clinic Florida\u2010Faecal Incontinence score \u22658 were enrolled prospectively; 22 received polydimethylsiloxane elastomer and 22 saline treatment. Treatment was well tolerated. At 3\u2003months, the percentage of subjects experiencing a successful treatment was not different between polydimethylsiloxane elastomer and saline groups (23% vs. 27%, respectively, <jats:italic>P<\/jats:italic>\u2003=\u20030.73). Moreover, Cleveland Clinic Florida\u2010Faecal Incontinence score was not significantly different between polydimethylsiloxane elastomer and saline groups (11.7\u2003\u00b1\u20034.7 vs. 11.4\u2003\u00b1\u20034.5, respectively, <jats:italic>P<\/jats:italic>\u2003=\u20030.79).<\/jats:p><jats:p><jats:bold>Conclusions<\/jats:bold> Polydimethylsiloxane elastomer implants cannot be recommended for treatment of severe faecal incontinence related to impaired internal anal sphincter.<\/jats:p>","DOI":"10.1111\/j.1365-2036.2007.03293.x","type":"journal-article","created":{"date-parts":[[2010,7,23]],"date-time":"2010-07-23T11:15:34Z","timestamp":1279883734000},"page":"1125-1132","source":"Crossref","is-referenced-by-count":62,"title":["Elastomer implants in faecal incontinence: a blind, randomized placebo\u2010controlled study"],"prefix":"10.1111","volume":"25","author":[{"given":"L.","family":"SIPROUDHIS","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"J.","family":"MORCET","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"F.","family":"LAIN\u00c9","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2007,2,19]]},"reference":[{"key":"e_1_2_5_2_2","doi-asserted-by":"publisher","DOI":"10.1136\/gut.50.4.480"},{"key":"e_1_2_5_3_2","doi-asserted-by":"publisher","DOI":"10.1007\/s10350-005-0249-8"},{"key":"e_1_2_5_4_2","doi-asserted-by":"publisher","DOI":"10.1136\/gut.16.6.482"},{"key":"e_1_2_5_5_2","doi-asserted-by":"publisher","DOI":"10.1136\/gut.6.1.64"},{"key":"e_1_2_5_6_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(96)09188-X"},{"key":"e_1_2_5_7_2","first-page":"CD002111","article-title":"Biofeedback and\/or sphincter exercises for the treatment of faecal incontinence in adults","volume":"3","author":"Norton C","year":"2006","journal-title":"Cochrane Database Syst Rev"},{"key":"e_1_2_5_8_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0009-9236(98)90073-X"},{"key":"e_1_2_5_9_2","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2036.1998.00361.x"},{"key":"e_1_2_5_10_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2036.2004.02151.x"},{"key":"e_1_2_5_11_2","doi-asserted-by":"publisher","DOI":"10.1136\/gut.48.3.356"},{"key":"e_1_2_5_12_2","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2168.2000.01306.x"},{"key":"e_1_2_5_13_2","first-page":"CD002116","article-title":"Drug treatment for faecal incontinence in adults","volume":"3","author":"Cheetham M","year":"2003","journal-title":"Cochrane Database Syst Rev"},{"key":"e_1_2_5_14_2","doi-asserted-by":"publisher","DOI":"10.1007\/s003840050098"},{"key":"e_1_2_5_15_2","first-page":"363","article-title":"Sacral spinal nerve stimulation for faecal incontinence: multicentre study","volume":"17","author":"Matzel KE","year":"2004","journal-title":"Lancet"},{"key":"e_1_2_5_16_2","doi-asserted-by":"publisher","DOI":"10.1002\/bjs.4977"},{"key":"e_1_2_5_17_2","doi-asserted-by":"publisher","DOI":"10.1007\/BF02660763"},{"key":"e_1_2_5_18_2","doi-asserted-by":"publisher","DOI":"10.1002\/bjs.4997"},{"key":"e_1_2_5_19_2","doi-asserted-by":"publisher","DOI":"10.1007\/BF02234337"},{"key":"e_1_2_5_20_2","doi-asserted-by":"publisher","DOI":"10.1136\/gut.44.1.77"},{"key":"e_1_2_5_21_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0399-8320(04)95012-9"},{"key":"e_1_2_5_22_2","doi-asserted-by":"publisher","DOI":"10.1136\/gut.51.2.225"},{"key":"e_1_2_5_23_2","doi-asserted-by":"publisher","DOI":"10.1007\/s10350-004-0760-3"},{"key":"e_1_2_5_24_2","doi-asserted-by":"publisher","DOI":"10.1007\/s10350-005-0307-2"},{"key":"e_1_2_5_25_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.gastro.2003.09.039"},{"key":"e_1_2_5_26_2","doi-asserted-by":"publisher","DOI":"10.1097\/01.sla.0000186281.09475.db"},{"key":"e_1_2_5_27_2","doi-asserted-by":"publisher","DOI":"10.1007\/s10350-005-0251-1"}],"container-title":["Alimentary Pharmacology &amp; 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