目次序 ...................................................................................................................................................................................... iii
はじめに.................................................................................................................................................................... iv
作成委員，評価委員 ..................................................................................................................................... viii

1診療アルゴリズム .................................................................................................................................... 2
一般医向け診療アルゴリズム ................................................................................................................ 2（泌尿器科）専門医向け診療アルゴリズム ...................................................................................... 42Clinical Questions .................................................................................................................................. 6
CQ1CQ2CQ3CQ4CQ5CQ6CQ7CQ8CQ9CQ10CQ11CQ12CQ13CQ14CQ15CQ16CQ17CQ18CQ19

男性下部尿路症状を悪化させる薬剤や生活習慣は何か ? ....................................... 6
血清 PSA 値の評価における留意点は何か ? .................................................................. 8
男性下部尿路症状の評価に排尿記録は推奨されるか ? ............................................ 8尿閉に対して，どのような対処が推奨されるか ? ...................................................... 9
夜間頻尿に対して，どのような初期診療が推奨されるか ?................................ 10
男性下部尿路症状に対して，どのような行動療法が推奨されるか ? ............ 12
前立腺肥大症に対して，α1 遮断薬の種類による有効性・安全性の違いはあるか ? ............................................................................................................................ 14
前立腺肥大症に対して，α1 遮断薬と PDE5 阻害薬の有効性に違いはあるか ? .......................................................................................................................................... 18
前立腺肥大症に対して，α1 遮断薬と PDE5 阻害薬の併用療法は推奨されるか ?...................................................................................................................................... 19
男性下部尿路症状に対して，健康食品・サプリメントなどの代替療法は推奨されるか ?.................................................................................................... 22
前立腺肥大症を伴う過活動膀胱に対して，α1 遮断薬と抗コリン薬またはβ3 作動薬の併用療法は推奨されるか ? ........................................................... 25
前立腺肥大症に対して，α1 遮断薬と 5α還元酵素阻害薬の併用療法は推奨されるか ? ............................................................................................................................ 28
一定期間のα1 遮断薬と 5α還元酵素阻害薬の併用療法後，いずれかの薬剤による単独療法への変更は推奨されるか ? ........................................................ 30
前立腺肥大症に対して，PDE5 阻害薬と 5α還元酵素阻害薬の併用療法は推奨されるか ?.................................................................................................... 31
性機能障害を危惧する患者に，どのような治療が推奨されるか ? ................. 32
前立腺肥大症患者が他科受診する場合に，注意すべきことは何か ? ............ 34
男性下部尿路症状を訴える患者は，どのような場合に専門医への紹介を考慮すべきか ? ....................................................................................................................... 35
男性下部尿路症状を訴える患者は，どのような場合に専門医から一般医への紹介を考慮すべきか ? ..................................................................................... 36
男性下部尿路症状の保険診療上の留意点は何か ? ................................................... 37
男性下部尿路症状・前立腺肥大症診療ガイドライン

ix男性下部尿路症状・前立腺肥大症診療ガイドライン

3

定義と解説 .................................................................................................................................................. 41
1 下部尿路症状総論 ...................................................................................................................................... 411）下部尿路症状（lower urinary tract symptom: LUTS）....................................................... 41a．蓄尿症状 ............................................................................................................................................... 42b．排尿症状 ............................................................................................................................................... 44
c．排尿後症状 .......................................................................................................................................... 44d．その他の症状 ..................................................................................................................................... 44e．症状症候群 .......................................................................................................................................... 44（1）膀胱痛症候群（painful bladder syndrome）.............................................................. 44（2）過活動膀胱（overactive bladder: OAB）..................................................................... 45（3）膀胱出口部閉塞（bladder outlet obstruction: BOO）を示唆する症状症候群................................................................................................................................... 452）男性下部尿路症状（male lower urinary tract symptom: MLUTS）............................. 453）下部尿路症状と類似・関連した用語........................................................................................... 45
a．従来から使用されている広義の排尿症状 ........................................................................... 45
b．刺激症状（irritative symptoms），閉塞症状（obstructive symptoms）.............. 45
c．前立腺症（prostatism）................................................................................................................. 46
d．下部尿路機能障害（lower urinary tract dysfunction: LUTD）.................................. 46
e．低活動膀胱（underactive bladder）...................................................................................... 46
f．尿閉（urinary retention）.............................................................................................................. 46
g．溢流性尿失禁（overflow incontinence）.............................................................................. 46
h．過知覚膀胱（hypersensitive bladder）................................................................................ 46
2 前立腺肥大症の定義（用語と疾患概念）........................................................................................ 48

4

疫学と自然史 ............................................................................................................................................ 49
1 男性下部尿路症状の疫学，自然史および危険因子 ................................................................ 491）男性下部尿路症状の疫学 ................................................................................................................... 492）男性下部尿路症状の自然史 .............................................................................................................. 503）男性下部尿路症状の危険因子 ......................................................................................................... 50
2 前立腺肥大症の疫学，危険因子および自然史 .......................................................................... 51
1）前立腺肥大症の有病率........................................................................................................................ 512）前立腺肥大症の危険因子 ................................................................................................................... 52
a．遺伝的要因 .......................................................................................................................................... 52
b．食事と嗜好品 ..................................................................................................................................... 52
c．肥満，高血圧，高血糖，脂質異常症，メタボリック症候群および性機能障害 .... 52d．その他の危険因子 ........................................................................................................................... 523）前立腺肥大症の自然史........................................................................................................................ 53a．組織学的な前立腺肥大症の発生・進展................................................................................ 53
b．前立腺体積の自然史....................................................................................................................... 53
c．下部尿路症状の自然史.................................................................................................................. 54d．尿流量の自然史 ................................................................................................................................ 544）進行の危険因子 ...................................................................................................................................... 55
a．下部尿路症状進行の危険因子 ................................................................................................... 55x目次

b．医療機関への受診を規定する要因 ......................................................................................... 55
c．尿閉や手術療法に至る危険因子 .............................................................................................. 55
d．前立腺肥大症患者に対する経過観察..................................................................................... 56

5病態 ................................................................................................................................................................... 58
1 男性下部尿路症状をきたす疾患 ........................................................................................................ 58
2 前立腺・下部尿路の疾患・病態 ........................................................................................................ 581）前立腺肥大症 ........................................................................................................................................... 58
a．前立腺腫大と相関しない膀胱出口部閉塞 ........................................................................... 60b．膀胱出口部閉塞による膀胱の排尿（排出）障害............................................................... 60c．膀胱出口部閉塞による膀胱の蓄尿障害................................................................................ 60（1）神経の変化................................................................................................................................... 60（2）膀胱平滑筋の変化 .................................................................................................................... 61（3）尿路上皮由来のメディエーター ....................................................................................... 61
d．尿道からの求心性刺激の亢進 ................................................................................................... 612）他の前立腺疾患 ...................................................................................................................................... 61
a．前立腺炎 ............................................................................................................................................... 61b．前立腺癌 ............................................................................................................................................... 623）膀胱の疾患・病態 ................................................................................................................................. 62a．膀胱炎.................................................................................................................................................... 62b．間質性膀胱炎 ..................................................................................................................................... 62c．膀胱癌.................................................................................................................................................... 63d．膀胱結石 ............................................................................................................................................... 63e．膀胱憩室 ............................................................................................................................................... 63
f．過活動膀胱（OAB）......................................................................................................................... 63
g．排尿筋低活動・低活動膀胱 ........................................................................................................ 63h．その他.................................................................................................................................................... 64（1）膀胱血流障害.............................................................................................................................. 64（2）自律神経系の活動亢進 .......................................................................................................... 65（3）膀胱の加齢................................................................................................................................... 65（4）膀胱の炎症................................................................................................................................... 654）尿道の疾患 ................................................................................................................................................ 66
a．尿道炎.................................................................................................................................................... 66
b．尿道狭窄 ............................................................................................................................................... 66
c．尿道憩室 ............................................................................................................................................... 66
3 神経系の疾患・病態 ................................................................................................................................. 66
1）脳の疾患 ..................................................................................................................................................... 66
a．脳血管障害 .......................................................................................................................................... 66
b．認知症.................................................................................................................................................... 67
c．パーキンソン病 ................................................................................................................................ 67
d．多系統萎縮症 ..................................................................................................................................... 67
e．正常圧水頭症 ..................................................................................................................................... 67

男性下部尿路症状・前立腺肥大症診療ガイドライン

xi男性下部尿路症状・前立腺肥大症診療ガイドライン

f．進行性核上性麻痺 ........................................................................................................................... 67
g．大脳白質病変 ..................................................................................................................................... 672）脊髄の疾患・病態 ................................................................................................................................. 68
a．脊髄損傷 ............................................................................................................................................... 68
b．多発性硬化症 ..................................................................................................................................... 68
c．脊髄腫瘍 ............................................................................................................................................... 68
d．脊椎変性疾患 ..................................................................................................................................... 68（1）脊柱管狭窄症.............................................................................................................................. 68（2）椎間板ヘルニア ......................................................................................................................... 69
e．脊髄血管障害 ..................................................................................................................................... 69
f．二分脊椎 ............................................................................................................................................... 693）末梢神経の疾患・病態........................................................................................................................ 69
a．糖尿病.................................................................................................................................................... 69
b．骨盤内手術後 ..................................................................................................................................... 70

4 その他の疾患・病態 ................................................................................................................................. 70
1）薬剤性.......................................................................................................................................................... 702）多尿............................................................................................................................................................... 703）睡眠障害 ..................................................................................................................................................... 704）心因性.......................................................................................................................................................... 71
5 前立腺肥大症に伴う固有の病態や合併症 .................................................................................... 71
1）前立腺肥大症の病態............................................................................................................................. 71
a．内分泌環境の変化 ........................................................................................................................... 72
b．炎症と虚血 .......................................................................................................................................... 72
c．アドレナリン受容体....................................................................................................................... 73
d．NO-cGMP 系..................................................................................................................................... 732）前立腺肥大症の合併症........................................................................................................................ 74
a．尿閉......................................................................................................................................................... 74
b．肉眼的血尿 .......................................................................................................................................... 74
c．膀胱結石 ............................................................................................................................................... 74
d．反復性尿路感染症 ........................................................................................................................... 74
e．腎後性腎不全 ..................................................................................................................................... 756診断 ................................................................................................................................................................... 79
1 基本評価........................................................................................................................................................... 791）症状と病歴の聴取 ................................................................................................................................. 79a．症状......................................................................................................................................................... 79b．病歴......................................................................................................................................................... 792）質問票による症状・QOL 評価 ....................................................................................................... 80
a．国際前立腺症状スコア（International Prostate Symptom Score: IPSS）と QOL スコア（IPSS-QOL）..................................................................................................... 80
b．過活動膀胱症状スコア（Overactive Bladder Symptom Score: OABSS）....... 80c．主要下部尿路症状スコア（Core Lower Urinary Tract Symptom Score:CLSS）................................................................................................................................................... 80xii

目次

d．前立腺肥大症影響スコア（BPH Impact Index: BII）..................................................... 81
e．キング健康質問票（King s Health Questionnaire: KHQ）......................................... 81
f．国際失禁会議質問票短縮版（International Consultation on Incontinence
Questionnaire-Short Form: ICIQ-SF）................................................................................. 81
g．過活動膀胱質問票（Overactive Bladder questionnaire: OAB-q）....................... 81
h．間質性膀胱炎症状スコア・問題スコア（Interstitial Cystitis Symptom/Problem Index: ICSI・ICPI）.................................................................................................... 81
i．前立腺症状スコア（National Institute of Health Chronic Prostatitis
Symptom Index: NIH-CPSI）.................................................................................................... 813）身体所見 ..................................................................................................................................................... 814）尿検査.......................................................................................................................................................... 815）血清前立腺特異抗原（prostate specific antigen: PSA）測定 ....................................... 826）尿流測定 ..................................................................................................................................................... 827）残尿測定 ..................................................................................................................................................... 828）超音波検査 ................................................................................................................................................ 83

2 選択評価........................................................................................................................................................... 871）排尿記録 ..................................................................................................................................................... 872）尿流動態検査（urodynamic study: UDS）................................................................................ 89
a．内圧尿流検査（pressure-flow study: PFS）....................................................................... 89b．膀胱内圧検査 ..................................................................................................................................... 903）腎機能検査（血清クレアチニン測定）......................................................................................... 904）上部尿路超音波検査............................................................................................................................. 90
3 その他の検査 ................................................................................................................................................ 911）膀胱・尿道内視鏡検査........................................................................................................................ 912）排尿時膀胱尿道造影，逆行性尿道造影...................................................................................... 913）尿細胞診，尿培養 ................................................................................................................................. 91
4 検査・診断の手順 ...................................................................................................................................... 92

7治療 ................................................................................................................................................................... 93
1 治療総論........................................................................................................................................................... 93
2 治療の推奨のグレード ............................................................................................................................ 94
3 経過観察........................................................................................................................................................... 97
4 行動療法........................................................................................................................................................... 981）生活指導 ..................................................................................................................................................... 982）骨盤底筋訓練・膀胱訓練 ................................................................................................................... 993）電気刺激療法，磁気刺激療法（electrical stimulation, magnetic stimulation,neuromodulation）.............................................................................................................................. 100
5 薬物療法......................................................................................................................................................... 102〔α1-adrenoceptor antagonists1）α1 アドレナリン受容体遮断薬（α1 遮断薬）
（α1-blockers）〕.................................................................................................................................... 102
a．タムスロシン（tamsulosin）..................................................................................................... 103
b．ナフトピジル（naftopidil）........................................................................................................ 103
c．シロドシン（silodosin）.............................................................................................................. 106
男性下部尿路症状・前立腺肥大症診療ガイドライン

xiii男性下部尿路症状・前立腺肥大症診療ガイドライン

d．長期有効性 ........................................................................................................................................ 1072）ホスホジエステラーゼ 5 阻害薬（phosphodiesterase-type 5 inhibitors:
PDE5 inhibitors）................................................................................................................................. 109
a．タダラフィル（tadalafil）........................................................................................................... 110
b．シルデナフィル（sildenafil）.................................................................................................... 112
c．バルデナフィル（vardenafil）.................................................................................................. 1123）5α還元酵素阻害薬（5α-reductase inhibitors）................................................................... 114
a．デュタステリド（dutasteride）............................................................................................... 114
b．フィナステリド（finasteride）................................................................................................. 1154）抗アンドロゲン薬（anti-androgen drugs）........................................................................... 116
a．クロルマジノン（chlormadinone）...................................................................................... 116
b．アリルエストレノール（allylestrenol）............................................................................... 117
5）抗コリン薬（anticholinergics，antimuscarinic drugs）................................................ 118
a．オキシブチニン（oxybutynin）/ オキシブチニン経皮吸収型製剤（oxybutynin patch）..................................................................................................................... 119
b．プロピベリン（propiverine）.................................................................................................... 119
c．トルテロジン（tolterodine）..................................................................................................... 120
d．ソリフェナシン（solifenacin）................................................................................................ 120
e．イミダフェナシン（imidafenacin）...................................................................................... 120
f．フェソテロジン（fesoterodine）............................................................................................ 1206）β3 アドレナリン受容体作動薬（β3 作動薬，β3 adrenergic agonist）（ミラベグロン mirabegron）......................................................................................................... 1217）併用療法 ................................................................................................................................................... 122
a．α1 遮断薬と抗コリン薬の併用療法 ...................................................................................... 122
b．α1 遮断薬とβ3 作動薬の併用療法.......................................................................................... 126
c．5α還元酵素阻害薬と抗コリン薬の併用療法 .................................................................. 127
d．5α還元酵素阻害薬とβ3 作動薬の併用療法...................................................................... 1278）その他の薬剤 ......................................................................................................................................... 128
a．エビプロスタット®（Eviprostat ®）....................................................................................... 128
b．セルニルトン ®（cernitine pollen extract，Cernilton®）........................................... 128
c．パラプロスト®（Paraprost ®）.................................................................................................. 128
d．漢方薬（八味地黄丸，牛車腎気丸）...................................................................................... 129
e．フラボキサート（flavoxate）.................................................................................................... 129
f．抗うつ薬 ............................................................................................................................................. 129
g．コリン作動薬 ................................................................................................................................... 130
h．健康食品，サプリメント ........................................................................................................... 131

6 手術療法......................................................................................................................................................... 1351）前立腺肥大症に対する手術療法 .................................................................................................. 135
a．被膜下前立腺腺腫核出術（simple prostatectomy, sub-capsularenucleation）.................................................................................................................................... 137（1）開放手術 ..................................................................................................................................... 137（2）腹腔鏡手術................................................................................................................................. 137（3）ロボット支援手術 .................................................................................................................. 139

xiv目次b．経尿道的前立腺切除術（transurethral resection of the prostate: TURP）...... 140（1）Monopolar TURP .................................................................................................................. 140（2）Bipolar TURP（生理食塩水灌流経尿道的前立腺切除術）.................................. 141
c．経尿道的前立腺切開術（transurethral incision of the prostate: TUIP）........... 142
d．経尿道的バイポーラ電極前立腺核出術（transurethral enucleation withbipolar system: TUEB®）.......................................................................................................... 143
e．ホルミウムレーザー前立腺核出術（holmium laser enucleation of theprostate: HoLEP）......................................................................................................................... 144
f．532 nm レーザー光選択的前立腺蒸散術（photoselective vaporizationof the prostate by KTP laser: PVP 80W-KTP，120W-LBO，180W-XPS）..... 145
g．半導体レーザー前立腺蒸散術（diode laser vaporization of the prostate）..... 147
h．ツリウムレーザー前立腺切除術（thulium laser resection of the prostate:ThuLRP）............................................................................................................................................ 148
i．組織内レーザー凝固術（interstitial laser coagulation of the prostate: ILCP）... 149
j．高密度焦点式超音波治療（high-intensity focused ultrasound: HIFU）............ 150
k．経尿道的針焼灼術（transurethral needle ablation: TUNA®）................................ 150
l．経尿道的マイクロ波高温度治療術（transurethral microwave
thermotherapy: TUMT）............................................................................................................. 151
m．尿道ステント（urethral stent）................................................................................................ 153
n．前立腺インプラント埋め込み尿道吊り上げ術（prostatic urethral lift: PUL）... 153
o．経尿道的水蒸気治療（water vapor）.................................................................................... 155
p．前立腺動脈塞栓術（prostatic arterial embolization）................................................. 156
2）その他の手術療法 ............................................................................................................................... 156

7 その他の治療 .............................................................................................................................................. 157
1）尿道留置カテーテル........................................................................................................................... 157
2）間欠導尿 ................................................................................................................................................... 157

8

前立腺肥大症の治療と性機能障害....................................................................................... 159
1 手術療法における性機能障害 ........................................................................................................... 159
1）勃起障害 ................................................................................................................................................... 159
2）射精障害 ................................................................................................................................................... 159
2 薬物療法における性機能障害 ........................................................................................................... 159
1）勃起障害 ................................................................................................................................................... 159
2）射精障害 ................................................................................................................................................... 160

9臨床試験に関連する基準.............................................................................................................. 161
1 対象患者の採用基準 ............................................................................................................................... 161
1）選択基準 ................................................................................................................................................... 161
2）除外基準 ................................................................................................................................................... 162
2 重症度判定基準 ......................................................................................................................................... 163
3 治療効果判定基準 .................................................................................................................................... 164
4 治療効果判定で留意すべき事項 ...................................................................................................... 165

索引 ........................................................................................................................................................................... 166
男性下部尿路症状・前立腺肥大症診療ガイドライン

xv