Context

Urethral stricture disease (USD) is initially managed with minimally invasive techniques such as urethrotomy and urethral dilatation. Minimally invasive techniques are associated with a high recurrence rate, especially in recurrent USD. Adjunctive measures, such as local drug injection, have been used in an attempt to reduce recurrence rates.

Objective

To systematically review evidence for the efficacy and safety of adjuncts used alongside minimally invasive treatment of USD.

Evidence acquisition

A systematic review of the literature published between 1990 and 2020 was conducted in accordance with the PRISMA checklist.

Evidence synthesis

A total of 26 studies were included in the systematic review, from which 13 different adjuncts were identified, including intralesional injection (triamcinolone, n = 135; prednisolone, n = 58; mitomycin C, n = 142; steroid-mitomycin C-hyaluronidase, n = 103, triamcinolone-mitomycin C-N-acetyl cysteine, n = 50; platelet-rich plasma, n = 44), intraluminal instillation (mitomycin C, n = 20; hyaluronic acid and carboxymethylcellulose, n = 70; captopril, n = 37; 192-iridium brachytherapy, n = 10), application via a lubricated catheter (triamcinolone, n = 124), application via a coated balloon (paclitaxel, n = 106), and enteral application (tamoxifen, n = 30; deflazacort, n = 36). Overall, 13 randomised controlled trials were included in the meta-analysis. Use of any adjunct was associated with a lower rate of USD recurrence (odds ratio [OR] 0.37, 95% confidence interval [CI] 0.27–0.50; p < 0.001) compared to no adjunct use. Of all the adjuncts, mitomycin C was associated with the lowest rate of USD recurrence (intralesional injection: OR 0.23, 95% CI 0.11–0.48; p < 0.001; intraluminal injection: OR 0.11, 95% CI 0.02–0.61; p = 0.01). Urinary tract infection (2.9–14%), bleeding (8.8%), and extravasation (5.8%) were associated with steroid injection; pruritis of the urethra (61%) occurred after instillation of captopril; mild gynaecomastia (6.7%) and gastrointestinal side effects (6.7%) were associated with oral tamoxifen.

Conclusions

Adjuncts to minimally invasive treatment of USD appear to lower the recurrence rate and are associated with a low adjunct-specific complication rate. However, the studies included were at high risk of bias. Mitomycin C is the adjunct supported by the highest level of evidence.

Patient summary

We reviewed studies on additional therapies (called adjuncts) to minimally invasive treatments for narrowing of the urethra in men. Adjuncts such as mitomycin C injection result in a lower recurrence rate compared to no adjunct use. The use of adjuncts appeared to be safe and complications are uncommon; however, the studies were small and of low quality.

中文翻译：

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辅助微创治疗男性尿道狭窄的系统评价和荟萃分析

语境

尿道狭窄疾病 (USD) 最初通过尿道切开术和尿道扩张术等微创技术进行治疗。微创技术与高复发率相关，尤其是在复发性 USD 中。辅助措施，例如局部药物注射，已被用于降低复发率。

客观的

系统评价与 USD 微创治疗一起使用的辅助药物的有效性和安全性的证据。

取证

根据 PRISMA 清单对 1990 年至 2020 年间发表的文献进行了系统评价。

证据综合

系统评价共纳入 26 项研究，从中确定了 13 种不同的辅助药物，包括病灶内注射（曲安西龙， n  = 135；强的松龙，n  = 58；丝裂霉素 C，n  = 142；类固醇-丝裂霉素 C-透明质酸酶，n  = 103，曲安西龙-丝裂霉素 C- N-乙酰半胱氨酸，n  = 50；富含血小板的血浆，n  = 44），腔内滴注（丝裂霉素 C，n  = 20；透明质酸和羧甲基纤维素，n  = 70；卡托普利，n  = 37；192-铱近距离放射治疗，n  = 10），通过润滑导管应用（曲安奈德，n  = 124），通过涂层球囊应用（紫杉醇，n  = 106）和肠内应用（他莫昔芬，n  = 30；deflazacort，n  = 36）。总体而言，荟萃分析纳入了 13 项随机对照试验。与不使用辅助相比，使用任何辅助都与较低的 USD 复发率相关（优势比 [OR] 0.37，95% 置信区间 [CI] 0.27–0.50；p  < 0.001）。在所有辅助药物中，丝裂霉素 C 与 USD 复发率最低相关（病灶内注射：OR 0.23，95% CI 0.11-0.48； p  < 0.001；腔内注射：OR 0.11，95% CI 0.02-0.61；p = 0.01)。尿路感染（2.9-14%）、出血（8.8%）和外渗（5.8%）与类固醇注射有关；滴注卡托普利后发生尿道瘙痒（61%）；轻度男性女性型乳房 (6.7%) 和胃肠道副作用 (6.7%) 与口服他莫昔芬有关。

结论

USD 的微创治疗的辅助似乎降低了复发率，并且与低辅助特异性并发症发生率相关。然而，纳入的研究存在高偏倚风险。丝裂霉素 C 是最高级别证据支持的辅助药物。

患者总结

我们回顾了关于微创治疗男性尿道狭窄的附加疗法（称为辅助疗法）的研究。与不使用辅助药物相比，注射丝裂霉素 C 等辅助药物的复发率较低。使用辅助药物似乎是安全的，并发症并不常见；然而，这些研究规模小，质量低。