應力性尿失禁（SUI）影響約40%的成年女性，常見於懷孕、生產或更年期後，因骨盆底肌肉與支持組織的減弱，導致運動或咳嗽時不自主漏尿。目前治療方式包括骨盆底肌訓練、藥物治療與手術，但手術可能帶來併發症，因此部分患者尋求非侵入性療法。鉺雅鉻（Er:YAG）陰道雷射近年來被提出，該技術被認為可透過熱能刺激膠原蛋白增生，增強陰道壁與尿道支持組織，進而改善應力性尿失禁。然而，該療法的臨床療效尚未獲得充分驗證。

本研究為最大規模的雙盲隨機對照試驗（RCT），納入144名女性，隨機分為雷射治療組與假治療組，所有受試者於6週內接受2次治療，並在6週與6個月後進行追蹤，以評估其對應力性尿失禁的療效。

研究結果顯示：(1) 6個月時，雷射與假治療組的主觀治癒率無顯著差異（雷射組1.36%，假治療組0%）。(2) 客觀與主觀測量數據皆無顯著改善，僅6週時部分生活品質指標稍有提升，但未能持續。(3) 雷射組患者術後疼痛顯著高於假治療組，顯示該療法可能導致不適。(4) 79%的雷射組患者仍尋求進一步治療，顯示其療效未達預期。

本研究與先前部分小型、非隨機研究的高治癒率（50%以上）形成對比，後者多缺乏對照組，易受安慰劑效應影響，導致結果的可靠性存疑。本研究透過雙盲設計與假治療對照，提供有力證據顯示鉺雅各陰道雷射對應力性尿失禁治療無明顯優勢。因此，臨床醫師應謹慎考量其應用，並確保患者獲得完整臨床資訊，避免因市場推廣或患者期待影響治療決策。

未來研究應進一步探討該療法對特定族群（如輕度應力性尿失禁患者）的可能療效，並進行長期追蹤，確認其潛在延遲療效或不良影響。本研究提供高品質證據，顯示鉺雅各陰道雷射並非有效的應力性尿失禁治療方式，臨床應聚焦於已有強力證據支持的治療選項，以確保患者獲得最佳照護。

Background: Stress urinary incontinence affects approximately 40% of adult females and is often treated surgically. Minimally invasive vaginal laser therapy to treat stress urinary incontinence has become widely available, but the efficacy of this novel therapy is unclear.

Objective: This study aimed to determine the efficacy of erbium-doped yttrium aluminum garnet laser as a therapy for stress urinary incontinence.

Study design: This was a double-blind randomized sham-controlled trial with 6-week and 6-month follow-ups at a single tertiary hospital setting with 144 adult female patients with symptomatic stress urinary incontinence. Each participant received 2 vaginal laser therapies 6 weeks apart, with patients randomized to either laser or sham. The primary outcome was patients' subjective reporting of no urinary incontinence at 6 months after treatment on question 3 of the International Consultation on Incontinence Questionnaire-Short Form. The secondary outcomes included objective measures of urine loss with 24-hour pad tests, 3 incontinence symptom questionnaires (Urogenital Distress Inventory-6, Incontinence Impact Questionnaire-7, and International Consultation on Incontinence Questionnaire-Short Form), 1 quality-of-life questionnaire (King's Health Questionnaire), and 1 sexual function questionnaire (Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire).

Results: Of 263 individuals approached, 76 of 144 individuals were randomized to the laser treatment group, and 68 of 144 individuals were randomized to the sham treatment group. There was no difference in the reported cure rate and the primary outcome at 6 months after treatment between the groups (laser treatment group: 0.0136; 95% confidence interval, 0.0006-0.0811; sham treatment group: 0.0000; 95% confidence interval, 0.0000-0.0666). Apart from a statistically significant difference noted at 6 weeks after treatment in 1 of 3 incontinence questionnaires and 3 of 9 domains of the quality-of-life questionnaire, there were no other significant differences in our subjective or objective measures between the 2 groups at 6 weeks and 6 months after treatment.

Conclusion: Er: YAG laser was no more effective than sham for curing or improving female stress urinary incontinence at 6 months.