男性前尿道狭窄：腔内治疗疗效如何？最新循证依据一览（下）
上一期：男性前尿道狭窄：腔内治疗疗效如何？最新循证依据一览（上）（点击即可跳转阅读）
3.3 单次扩张
UD可在门诊局部麻醉下进行，无需复杂设备。尽管无直接比较盲法与视觉引导UD的研究，多项研究报告视觉引导UD并发症发生率低。复发率差异较大，为23.5%～64.5%。一项系统综述仅发现一项比较UD与DVIU的前瞻性RCT，未发现显著差异。一项小型回顾性队列研究报告，球囊扩张与标准丝状探子扩张的效果相当。
3.4 扩张/DVIU后策略
为防止创面挛缩、改善无狭窄率和UD/DVIU后狭窄复发时间，已开发了若干策略。
3.4.1 间歇性自我扩张（ISD）
一项系统综述纳入6项（准）随机试验，比较有无ISD的情况下随访8至24个月的结局。ISD组狭窄复发率（85/197，43%）显著低于非ISD组（128/207，62%）（RR=0.7；95%CI=0.48~1.00），但研究异质性较大，研究质量极低，作者认为估计值存在不确定性。该综述得出结论：ISD对前尿道狭窄疾病“可能有效”（moderate certainty evidence）。
一项多中心前瞻性研究（n=85）报告，35%患者导尿困难为中度，26%为重度；32%患者自我扩张时疼痛为中度，17%为重度。导尿对QoL影响显著：32%评为中度影响，55%评为重度影响。年龄较小被识别为QoL较差的预测因素，近端尿道位置（后尿道和球部）受损更为明显。大多数患者至少每天一次导尿。
3.4.2 ISD联合尿道内皮质类固醇
为延缓尿道狭窄部位的创面挛缩，尿道内皮质类固醇（作为导管润滑剂）被用于改善ISD的疗效。2023年，本专家组进行了一项系统综述，纳入5项前瞻性RCTs，比较ISD联合局部类固醇（曲安奈德软膏）与单独ISD的结局，最长允许ISD时间为6个月，共124例患者随机分配至局部类固醇组，126例未使用。Meta分析显示，类固醇组在6个月（RR=0.63；95%CI=0.44~0.91）和12个月（RR=0.73；95%CI=0.59~0.90）时复发率改善；复发时间改善（HR=0.43；95%CI=0.22~0.82）。
一项关于苔藓硬化症（lichen sclerosus, LS）相关尿道狭窄的小型队列研究中，尿道内皮质类固醇方案在平均随访25个月后使25例（89%）患者成功，以避免后续升级治疗为成功标准。该方案采用氯倍他索乳膏0.05%作为每天两次校准导尿的润滑剂，持续至少2个月。最终，12例（42.8%）患者实现导尿彻底去校准，10例（35.7%）患者持续导尿频率降低。
3.4.3 腔内注射
辅助腔内注射旨在减少成纤维细胞增殖和尿道过度瘢痕化。一项系统综述纳入7项RCTs（365例患者），比较DVIU后局部尿道内皮质类固醇（外用或注射曲安奈德）与不使用类固醇的结局，发现复发率改善（RR=0.67；95%CI=0.49~0.90）和复发时间改善（HR=0.58；95%CI=0.39~0.87）。
一项小型RCT比较了DVIU后注射丝裂霉素C（mitomycin C, MMC）与空白对照，发现MMC组12个月无复发率为68%，对照组为50%（HR=0.48；95%CI=0.23～0.99）。一项小型前瞻性队列研究探索了DVIU后富血小板血浆（platelet-rich plasma, PRP）注射，报告6个月无复发率为89%（33/37），12个月为81%（30/37）；对照组（历史对照）分别为67%和56%。
3.4.4 尿道支架
尿道支架设计用于抵抗UD或DVIU后的创面挛缩。支架置入操作简短（<60分钟），可在局部麻醉或脊髓麻醉下轻松实施。目前市售的只有临时支架（6至12个月后可取出）。一项比较UD/DVIU与UD/DVIU+临时支架置入治疗球部尿道狭窄的RCT报告，支架组的无狭窄生存时间显著延长（中位292天 vs 84天；HR=0.37；95% CI=0.19～0.73），12个月时无狭窄率更高（59% vs 27%；p=0.002）。
3.4.5 药物涂层球囊扩张（DCBD）
药物涂层球囊扩张（drug-coated balloon dilatation, DCBD）旨在通过紫杉醇的抗有丝分裂作用减少瘢痕形成。ROBUST-III RCT前瞻性随机纳入至少2次先前内镜治疗失败的球部尿道狭窄患者（<3cm），分配至DCBD（n=79）或UD/DVIU（n=48）组。主要终点为12个月时治疗成功（定义为不需要再治疗和无解剖性失败）：DCBD组为76.6%，对照组为33.3%（p<0.001）。次要终点方面，两年时DCBD成功率（61.7%）显著高于对照组（20.8%）（HR=0.31；95%CI=0.18～0.53）。
ROBUST-I研究——前瞻性、单臂，纳入球部狭窄<2cm、既往1～4次腔内干预——显示5年估计无再治疗生存率为71.7%，功能成功率（定义为国际前列腺症状评分[IPSS]改善>50%）为58%。使用30F球囊的功能成功率（77%）显著高于24F球囊（38%），建议尽可能使用30F球囊。未发现紫杉醇相关毒性反应。
| 推荐意见 | 推荐强度 |
|---|---|
| 【直视内切开术】 | |
| 强 | |
| 强 | |
| 弱 | |
| 弱 | |
| 强 | |
| 【扩张与直视内切开术疗效比较】 | |
| 弱 | |
| 强 | |
| 【间歇性自我扩张联合尿道内皮质类固醇】 | |
| 弱 | |
| 弱 | |
| 【病灶内注射】 | |
| 弱 | |
| 【药物涂层球囊扩张】 | |
| 强 | |
| 推荐意见 | 推荐强度 |
|---|---|
| 【远端尿道狭窄（尿道外口狭窄、舟状窝狭窄）】 | |
| 弱 | |
| 【阴茎段尿道狭窄的尿道成形术】 | |
| 强 | |
| 弱 | |
| 强 | |
| 强 | |
| 【尿道下裂修复失败相关狭窄的特殊考量】 | |
| 弱 | |
| 弱 | |
| 强 | |
| 【LS相关阴茎段尿道狭窄的特殊考量】 | |
| 强 | |
| 弱 | |
| 【球部尿道狭窄的尿道成形术】 | |
| 强 | |
| 弱 | |
| 强 | |
| 弱 | |
| 强 | |
| 弱 | |
| 弱 | |
| 弱 | |
| 弱 | |
| 强 | |
| 【阴茎段-球部或全尿道狭窄的尿道成形术】 | |
| 弱 | |
| 弱 | |
| 【会阴尿道造口术（PU）】 | |
| 强 | |
| 弱 | |
| 弱 | |
| 弱 | |
| 弱 | |
表4和表5分别列出了内镜治疗和前尿道狭窄外科治疗的推荐意见摘要。“冷刀”或激光能量DVIU安全，可作为门诊手术实施。DVIU通畅率差异较大，部分原因在于狭窄的异质性及不同作者对通畅的定义不同。DVIU的手术适应证取决于多种与预后相关的狭窄特征；但需重点注意：孤立性阴茎段尿道狭窄应避免DVIU（ED风险高，通畅率差）。
根据“冷刀”DVIU与LU的矛盾结果，以及系列研究的异质性和缺乏长期随访，现有研究不支持一种技术优于另一种。鉴于技术间并发症率相似，无法推荐一种技术优于另一种。
使用扩张器扩张球部尿道狭窄时，需要丰富经验以避免在狭窄处意外穿透尿道。为降低“传统”盲法硬探扩张的风险（尤其是假道、海绵体穿孔、尿道出血），其他策略已被开发和评估，主要是导丝引导后的视觉引导扩张。
目前，缺乏证据支持UD优于DVIU（反之亦然），因此单次扩张的指征与DVIU相同。应避免以治愈为目的的反复扩张/DVIU，因为无法期望长期无复发，且存在显著增加狭窄长度和复杂性、延迟通畅率更好的尿道成形术时机的风险。
多种策略被提出以减少UD/DVIU后的创面挛缩，但这些策略倾向于稳定尿道狭窄——延长复发时间——而非使患者保持无狭窄状态，其报告结局应在此背景下理解。
ISD稳定狭窄的潜在获益须与其缺点（导尿困难、疼痛和对QoL的影响）相权衡。如前所述，反复扩张（包括ISD）会增加狭窄复杂性并延迟尿道成形术时机。
在LS相关狭窄中，使用超效能尿道内皮质类固醇软膏进行ISD可能高度有效（89%），但由于多数患者持续在校准导管上涂抹类固醇，这一高“成功率”须审慎看待，应被视为狭窄稳定而非治愈。
不同辅助药物（MMC、皮质类固醇）被注射于男性尿道狭窄的微创治疗中。由于缺乏设计良好、充分有效的RCTs，加之当前文献标准化（剂量、技术、体积等）不足，建议进行细致的临床评估和在临床试验框架内进行前瞻性数据收集。近期，DVIU后使用PRP显示出良好效果，但在广泛临床应用前需要进一步验证。
临时支架的并发症比永久性支架少且较轻，但无直接比较数据。支架失败后，后续尿道成形术（通常需取出支架）是可行的，但与最初就行尿道成形术相比，手术往往更为复杂。由于永久性支架的不锈钢丝随时间完全嵌入尿道壁——通常6个月内上皮化——尿道海绵体受到严重损伤。后续尿道成形术通常复杂，基于上述局限性，目前不建议使用永久性尿道支架。
DCBD作为内镜治疗后复发性尿道狭窄的补救治疗显示出实用价值，尤其适用于ROBUST适应证——球部狭窄、<3cm、内镜干预失败后。超出上述适应证范围时，现有证据十分有限，不足以给出有临床参考意义的推荐意见。专家组建议在ROBUST适应证以外的狭窄使用DCBD时，在临床试验或登记研究框架内收集数据。
男性前尿道狭窄的腔内治疗安全，在特定情况下可提供良好的长期通畅率。对于希望接受微创治疗但接受长期成功率较低的患者，腔内治疗是一种选择。应讨论并调整反复内镜治疗方案，因为这些治疗可能加重狭窄。临床应充分评估各类治疗方案，对男性前尿道狭窄实行个体化精准治疗；必要时可选择药物涂层球囊扩张术（DCBD），或适时转诊行尿道成形术。
参考文献（上下滑动阅读）
[1] Lumen N, Campos-Juanatey F, Dimitropoulos K, Greenwell T, et al. EAU Guidelines on Urethral Strictures. London: Presented at the EAU Annual Congress; 2026.
[2] Licari LC, Bologna E, Manfredi C, et al. Incidence and management of BPH surgery-related urethral stricture: results from a large U.S. database. Prostate Cancer Prostatic Dis 2024;27:537–43.
[3] Verla W, Barratt R, Chan G, et al. Is a course of intermittent self-dilatation with topical corticosteroids superior at stabilising urethral stricture disease in men and improving functional outcomes over a course of intermittent self-dilation alone? A systematic review and meta-analysis. Eur Urol Open Sci 2023;51:95–105.
[4] DeLong J, Virasoro R, Pichardo M, et al. Long-term outcomes of recurrent bulbous urethral stricture treatment with the Optilume drug-coated balloon: five-year results from the ROBUST I Study. J Urol 2025;213:90–8.
[5] Goulao B, Carnell S, Shen J, et al. Surgical Treatment for Recurrent Bulbar urethral Stricture: A Randomised Open-label Superiority Trial of Open urethroplasty versus Endoscopic urethrotomy (the OPEN Trial). Eur Urol 2020;78:572–80.
[6] Horiguchi A, Shinchi M, Masunaga A, Ito K, Asano T, Azuma R. Do transurethral treatments increase the complexity of urethral strictures? J Urol 2018;199:508–14.
[7] Guyatt GH, Oxman AD, Kunz R, et al. What is “quality of evidence” and why is it important to clinicians? BMJ 2008;336:995–8.
[8] Guyatt GH, Oxman AD, Vist GE, et al. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ 2008;336:924–6.
[9] Steenkamp JW, Heyns CF, de Kock ML. Internal urethrotomy versus dilation as treatment for male urethral strictures: a prospective, randomized comparison. J Urol 1997;157:98–101.
[10] Güler Y. Urethral injury treatment challenge. Comparison of surgical treatments for acquired or iatrogenic urethral stenosis and predictive values for failure of each surgical method. Folia Med (Plovdiv) 2021;63:42–50.
[11] Sitaram M, Reddy SJ, Chawla A, et al. Patient-reported outcome measures using modified urethral stricture surgery: patient-reported outcome measure for direct visual internal urethrotomy and nontransecting urethroplasty for short nontraumatic bulbar urethral stricture – A prospective comparative observational study from a University Teaching Hospital. Urol Sci 2023;34:124–30.
[12] Kluth LA, Ernst L, Vetterlein MW, et al. Direct vision internal urethrotomy for short anterior urethral strictures and beyond: success rates, predictors of treatment failure, and recurrence management. Urology 2017;106:210–5.
[13] Barbagli G, Fossati N, Montorsi F, et al. Focus on internal urethrotomy as primary treatment for untreated bulbar urethral strictures: results from a multivariable analysis. Eur Urol Focus 2020;6:164–9.
[14] Shen J, Vale L, Goulao B, et al. Endoscopic urethrotomy versus open urethroplasty for men with bulbar urethral stricture: the OPEN randomised trial cost-effectiveness analysis. BMC Urol 2021;21:76.
[15] Brown ET, Mock S, Dmochowski R, Reynolds WS, Milam D, Kaufman MR. Direct visual internal urethrotomy for isolated, post-urethroplasty strictures: a retrospective analysis. Ther Adv Urol 2017;9:39–44.
[16] Rosenbaum CM, Schmid M, Ludwig TA, et al. Internal urethrotomy in patients with recurrent urethral stricture after buccal mucosa graft urethroplasty. World J Urol 2015;33:1337–44.
[17] Endo D, Robayo J, García-Perdomo HA. Predictors of urethral stricture recurrence following internal urethrotomy: a systematic review. Urologia 2025;92:32–8.
[18] Jin T, Li H, Jiang LH, Wang L, Wang KJ. Safety and efficacy of laser and cold knife urethrotomy for urethral stricture. Chin Med J (Engl) 2010;123:1589–95.
[19] Graversen PH, Rosenkilde P, Colstrup H. Erectile dysfunction following direct vision internal urethrotomy. Scand J Urol Nephrol 1991;25:175–8.
[20] Wong SSW, Aboumarzouk OM, Narahari R, O’Riordan A, Pickard R. Simple urethral dilatation, endoscopic urethrotomy, and urethroplasty for urethral stricture disease in adult men. Cochrane Database Syst Rev 2012;12:CD006934.
[21] Yu SC, Wu HY, Wang W, et al. High-pressure balloon dilation for male anterior urethral stricture: single-center experience. J Zhejiang Univ Sci B 2016;17:722–7.
[22] Hudak SJ, Atkinson TH, Morey AF. Repeat transurethral manipulation of bulbar urethral strictures is associated with increased stricture complexity and prolonged disease duration. J Urol 2012;187:1691–5.
[23] Heyns CF, Steenkamp JW, De Kock ML, Whitaker P. Treatment of male urethral strictures: is repeated dilation or internal urethrotomy useful? J Urol 1998;160:356–8.
[24] Al Taweel W, Seyam R. Visual internal urethrotomy for adult male urethral stricture has poor long-term results. Adv Urol 2015;2015:656459.
[25] Pal DK, Kumar S, Ghosh B. Direct visual internal urethrotomy: is it a durable treatment option? Urol Ann 2017;9:18–22.
[26] Launonen E, Sairanen J, Ruutu M, Taskinen S. Role of visual internal urethrotomy in pediatric urethral strictures. J Pediatr Urol 2014;10:545–9.
[27] Redón-Gálvez L, Molina-Escudero R, Álvarez-Ardura M, Otaola-Arca H, Alarcón Parra RO, Páez-Borda Á. Predictors of urethral stricture recurrence after endoscopic urethrotomy. Actas Urol Esp 2016;40:529–33.
[28] Torres Castellanos L, Moreno Bencardino MC, Bravo-Balado A, García Mayorga CA, Vargas Manrique I, Fernández N. Evaluation of the Efficacy and Safety of Laser versus Cold Knife urethrotomy in the Management of Patients with urethral strictures: a systematic review and meta-analysis of randomized clinical trials. Urol Int 2017;99:453–9.
[29] Jiangang Chen LQ, Zheng B, Lu M. Comparison of holmium laser combined ureteroscopy and cold knife urethrotomy in treatment of simple urethral stricture: a 5 year follow-up study. Int J Clin Exp Med 2018;11:13792–6.
[30] Yenice MG, Seker KG, Sam E, et al. Comparison of cold-knife optical internal urethrotomy and holmium:YAG laser internal urethrotomy in bulbar urethral strictures. Cent Eur J Urol 2018;71:114–20.
[31] Gamal MA, Higazy A, Ebsharoun SF, Radwan A. Holmium: YAG versus Cold knife internal urethrotomy in the management of short urethral strictures: a randomized controlled trial. J Lasers Med Sci 2021;12:e35.
[32] Ali MM, Kamel M, Ragab A, Abd Alraheem A, Sakr A. Holmium laser versus cold knife visual internal urethrotomy for management of short segment urethral stricture: a prospective randomized clinical trial. World J Urol 2023;41:1897–904.
[33] Akdemir F, Okulu E, Kayigil Ö. Comparison of using cold knife and holmium laser in urethral stricture: long-term outcomes. J Urol Surg 2023;10:315–20.
[34] Cecen K, Karadag MA, Demir A, Kocaaslan R. PlasmaKinetic™ versus cold knife internal urethrotomy in terms of recurrence rates: a prospective randomized study. Urol Int 2014;93:460–3.
[35] Ozcan L, Polat EC, Otunctemur A, et al. Internal urethrotomy versus plasmakinetic energy for surgical treatment of urethral stricture. Arch Ital Urol Androl 2015;87:161–4.
[36] Basok EK, Basaran A, Gurbuz C, Yildirim A, Tokuc R. Can bipolar vaporization be considered an alternative energy source in the endoscopic treatment of urethral strictures and bladder neck contracture? Int Braz J Urol 2008;34:577–84, discussion 84–6.
[37] Beeder LA, Cook GS, Nealon SW, et al. Long-term experience with balloon dilation for short bulbar and membranous urethral strictures: establishing a baseline in the active drug treatment era. J Clin Med 2022;11:3095.
[38] Jackson MJ, Veeratterapillay R, Harding CK, Dorkin TJ. Intermittent self-dilatation for urethral stricture disease in males. Cochrane Database Syst Rev 2014;2014:CD010258.
[39] Chhabra JS, Balaji SS, Singh A, et al. Urethral balloon dilatation: factors affecting outcomes. Urol Int 2016;96:427–31.
[40] Greenwell TJ, Castle C, Nicol DL. Clean intermittent self-catheterization does not appear to be effective in the prevention of urethral stricture recurrence. Scand J Urol 2016;50:71–3.
[41] Lubahn JD, Zhao LC, Scott JF, et al. Poor quality of life in patients with urethral stricture treated with intermittent self-dilation. J Urol 2014;191:143–7.
[42] Scheipner L, Jankovic D, Jasarevic S, et al. Patient reported outcomes of intermittent self-dilatation after direct vision internal urethrotomy. Neurourol Urodyn 2024;43:664–71.
[43] Hosseini J, Mirjalili AM, Sharifian R, Abouei S, Tajamolian R, Samadaee GK. Outcomes of HUD versus CIC in patients with urethral strictures. Am J Mens Health 2023;17:15579883231202714.
[44] Potts BA, Belsante MJ, Peterson AC. Intraurethral steroids are a safe and effective treatment for stricture disease in patients with biopsy proven lichen sclerosus. J Urol 2016;195:1790–6.
[45] Soliman C, Pan HYC, Mulholland CJ, et al. Effect of local steroids on urethral strictures: a systematic review and meta-analysis. Investig Clin Urol 2022;63:273–84.
[46] Pang KH, Chapple CR, Chatters R, et al. A systematic review and meta-analysis of adjuncts to minimally invasive treatment of urethral stricture in men. Eur Urol 2021;80:467–79.
[47] Xu C, Zhu Z, Lin L, Lv T, Cai T, Lin J. Efficacy of mitomycin C combined with direct vision internal urethrotomy for urethral strictures: A systematic review and meta-analysis. Urol Int 2023;107:344–57.
[48] Rezaei M, Badiei R, Badiei R. The effect of platelet-rich plasma injection on post-internal urethrotomy stricture recurrence. World J Urol 2019;37:1959–64.
[49] Jordan GH, Wessells H, Secrest C, et al. Effect of a temporary thermo-expandable stent on urethral patency after dilation or internal urethrotomy for recurrent bulbar urethral stricture: results from a 1-year randomized trial. J Urol 2013;190:130–6.
[50] Wong E, Tse V, Wong J. Durability of Memokath™ urethral stent for stabilisation of recurrent bulbar urethral strictures – medium-term results. BJU Int 2014;113(Suppl. 2):35–9.
[51] Sedigh O, Dalmasso E, Gobbo A, et al. Feasibility and outcomes of temporary bulbar urethral stent placement after internal urethrotomy in the largest multicenter series. Eur Urol 2023;84:313–20.
[52] Erickson BA, McAninch JW, Eisenberg ML, Washington SL, Breyer BN. Management for prostate cancer treatment related posterior urethral and bladder neck stenosis with stents. J Urol 2011;185:198–203.
[53] Jung HS, Kim JW, Lee JN, Kim HT, Yoo ES, Kim BS. Early experience with a thermo-expandable stent (memokath) for the management of recurrent urethral stricture. Korean J Urol 2013;54:851–7.
[54] Angulo JC, Kulkarni S, Pankaj J, et al. Urethroplasty after urethral Urolume stent: an international multicenter experience. Urology 2018;118:213–9.
[55] Angulo JC, Pankaj J, Arance I, Kulkarni S. Urethral reconstruction in patients previously treated with Memokath urethral endoprosthesis. Actas Urol Esp (Engl Ed) 2019;43:26–31.
[56] Elliott SP, Coutinho K, Robertson KJ, et al. One-year results for the ROBUST III randomized controlled trial evaluating the Optilume® drug-coated balloon for anterior urethral strictures. J Urol 2022;207:866–75.
[57] VanDyke ME, Morey AF, Coutinho K, et al. Optilume drug-coated balloon for anterior urethral stricture: 2-year results of the ROBUST III trial. BJUI Compass 2024;5:366–73.
[58] Mahenthiran AK, Burns RT, Soyster ME, et al. A single-institution experience with the Optilume urethral Drug Coated Balloon for management of urethral stricture disease. Transl Androl Urol 2024;13:1498–505.
[59] Ballesteros Ruiz C, Campos-Juanatey F, Povo Martín I, et al. Efficacy and safety of Optilume®paclitaxel-coated urethral dilatation balloon in real-life: experience in a Spanish multicenter study. Actas Urol Esp (Engl Ed) 2025;49:80–5.
[1]中华医学会妇产科学分会妇科盆底学组. 女性压力性尿失禁诊断和治疗指南(2017)[J]. 中华妇产科杂志,2017(5).
声明：本内容仅供医学药学专业人士阅读，不构成实际治疗建议。转载请后台联系授权，侵权必究！ 编辑：吴梦霞 审核：黄鹏程