便失禁に対する仙骨神経刺激療法 前向き多施設共同研究 第67巻06号0371頁

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5 日本大腸肛門病会誌 年間 1-1 号 第 67 巻第 6 号 (%) 年 6 月 山名哲郎ほか 375 (%) Test period 4.8 1M 3M 6M Test period 1M 3M 6M (n = 22) (n = 16) (n = 16) (n = 16) (n = 16) % Fig % 5-75% % Improvement categories in weekly incontinent episodes (%) % % 5-75% 75-1% Fig. 5 Improvement categories in weekly urgent incontinent episodes 値が 39.1mmHg となり有意に上昇した p=.26 8 最大随意収縮圧はベースラインの平均値が mmhg 術後 6 ヵ月の時点の平均値が 13.5mmHg と有意差は認められなかった p= 有害事象 装置との因果関係が否定できない有害事象は埋め 込みをした 21 人中の 11 人 52.4 に認められた Table 3 埋め込み部の感染を発症した 2 人につい Test period 1M 3M 6M ては抗生物質の投与のみで軽快した その他の有害 (n = 22) 事象についても投薬などの最小限の介入で症状の軽 % Fig % 5-75% 75-1% Improvement categories in weekly incontinent days 快が得られた これまで報告されていない装置と関 連した未知の有害事象は 今回の治験では認められ なかった と比較して 5 以上減少する患者の割合はそれぞ れ 71.4 と 75. であった Fig. 4 5 考 察 仙骨神経を電気的に刺激して骨盤臓器の機能を改 便失禁症状のスコアである FISI および CCSI も 善させる SNM のメカニズムの研究は 198 年から 術後 1 ヵ月で有意な低下が認められ その後は 6 ヵ 9 年代にかけて泌尿器科領域において行われたの 月まで同等の効果が維持された Fig. 6 QOL 評価 が始まりである14) 便失禁の治療における SNM の では JFIQL のスコアが生活スタイル 対処/日常行 効果発現のメカニズムはこれまでの報告によると 動 憂鬱感/自己認識 羞恥心の 4 つの項目すべてで 仙骨神経への電気刺激によって体性神経の運動線 スコアの有意な上昇が認められ 本治療が便失禁症 維15-22) 知覚線維15) 自律神経15,17,2) 中枢神経23)が刺 状に関連した QOL を改善していた Fig. 7 激され 内外肛門括約筋の機能 肛門の感覚 直腸 4 肛門内圧検査 の感覚や運動機能 結腸の運動機能が改善し その 各評価時点での肛門内圧検査の結果を Table 2 に 複合的な結果として便失禁が減少しているものと推 示す 肛門管最大静止圧がベースラインの平均値が 察されている しかしこれまでの臨床研究では直腸 28.4mmHg であったのが 術後 6 ヵ月の時点の平均 肛門機能の生理学的パラメーターの治療前後の変化

6 Baseline 1M 3M 6M Fecal Incontinence Severity Index Baseline 1M 3M 6M Cleveland Clinic Incontinence Score Lifestyle / Coping/Behavior / Depression/Self Perception Embarrassment 1 BL 1M 3M 6M

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9 Sacral Neuromodulation for Fecal Incontinence: A Prospective Multicenter Trial in Japan Purpose: The use of sacral neuromodulation (SNM) to treat fecal incontinence (FI) has been officially approved in the EU since 1994 and the US since 211. The purpose of this trial, the first prospective study conducted in Asia, was to determine the safety and efficacy of SNM in accordance with the government approval protocol in Japan. Methods: Candidates for SNM who provided informed consent were enrolled in this institutional review board-approved multicenter prospective trial. Experiencing more than two incontinent episodes per week, not just staining, was part of the inclusion criteria. Patients showing 5 improvement during test stimulation received chronic implantation of the InterStim System (Medtronic; Minneapolis, MN). The primary efficacy objective was to demonstrate that 5 of subjects would achieve therapeutic success, defined as 5 reduction of incontinent episodes per week at 6 months compared with baseline. Results: A total of 22 patients underwent test stimulation with a 95 success rate, and 21 (12 females) with a mean age of 66.6 years and a mean duration of FI of 4.8 years received chronic implantation. At 6 months, 85.7 of subjects achieved therapeutic success (p=.7). Incontinent episodes significantly decreased from a mean of 14.9 per week at baseline to 3.1 at 6 months (p=.135). Anal manometry showed that preoperative maximum resting pressure (28.4mmHg) had significantly increased (39.1mmHg) at 6-month follow-up (p=.26). There were no reported unanticipated adverse device effects associated with InterStim Therapy. Conclusions: SNM using InterStim System is a safe and effective treatment for Japanese patients with FI.

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