目前無張力尿道中段陰道膠帶懸吊手術(TVT)為婦女應力性尿失禁(SUI)手術之主流。其中原因是，過往經尿道注射尿道黏膜下填充物的效益被受質疑。縱使注射尿道黏膜下填充物之副作用比TVT低，但效果往往無法持久。這篇文章比較了尿道黏膜下注射聚丙烯醯胺水凝膠(polyacrylamide hydrogel (PAHG))與TVT之臨床效益。

研究隨機分配224名SUI患者接受TVT或PAHG，追蹤時間為一年。111人接受TVT，113人接受PAHG。在1年時，TVT組之滿意度為95.0%，而PAHG組之滿意度僅為66.4%（差異28.6%，95%CI 18.4-38.5）。然而，大多數併發症都發生於TVT組。TVT組發生19例，PAHG只有3例（差異16.0%、95%CI 7.8-24.9）。所有因併發症而需要手術處理的案例(6例)均發生於TVT組。

TVT與PAHG比較，顯然有更好的滿意度和治癒率。然而，併發症也主要發生在TVT組，而PAHG也有過半的滿意度和治癒率。因此，如果患者很在意併發症的風險，又或SUI還沒有太嚴重，PAHG是有意義的替代治療方式。

Purpose: We evaluated whether polyacrylamide hydrogel is noninferior to tensionfree vaginal tape to treat women with primary stress urinary incontinence.

Materials and Methods: In this controlled noninferiority clinical trial patients with primary stress urinary incontinence were randomized to tension-free vaginal tape or polyacrylamide hydrogel treatment. The primary outcome was patient satisfaction and secondary outcomes were effectiveness in reducing urinary leakage and complications at 1-year followup. For statistical power significance was considered at 5%, power was set at 80% and the noninferiority limit was 20% with a 10% expected dropout rate.

Results: A total of 224 women with primary stress urinary incontinence entered the study between September 28, 2015 and March 1, 2017. Of the women 111 were randomized to tension-free vaginal tape and 113 were randomized to polyacrylamide hydrogel. At 1 year a satisfaction score of 80 or greater on a visual analogue scale of 0 to 100 was reached in 95.0% and 59.8% of patients treated with tension-free vaginal tape and polyacrylamide hydrogel, respectively. Thus, polyacrylamide hydrogel did not meet the noninferiority criteria set in our study. As secondary outcomes, the cough stress test was negative in 95.0% of tension-free vaginal tape cases vs 66.4% of polyacrylamide hydrogel cases (difference 28.6%, 95% CI 18.4-38.5). However, most perioperative complications, including those in 19 tension-free vaginal tape cases vs 3 polyacrylamide hydrogel cases (difference 16.0%, 95% CI 7.8-24.9), and all 6 reoperations due to complications (difference 5.9%, 95% CI 1.2-12.4) were associated with tensionfree vaginal tape.

Conclusions: Mid urethral tension-free vaginal tape slings were associated with better satisfaction and cure rates than polyacrylamide hydrogel in women with primary stress urinary incontinence. However, complications were mainly associated with tension-free vaginal tape. Thus, tension-free vaginal tape should be offered as first line treatment in women who expect to be completely cured by the initial treatment and are willing to accept the complication risks. Since polyacrylamide hydrogel treatment also provides high satisfaction and cure rates, women with primary stress urinary incontinence can be offered polyacrylamide hydrogel as an alternative treatment.