METHODS: This randomized controlled trial included 52 patients with Hunner-type IC/BPS allocated at a 1:1 (TUF:TUF+HD) ratio. HD was performed at 80 cmH2O for 8 min before TUF in the TUF+HD group. Thirty-three patients remained until the end of the 6-month observational period. The primary endpoint was the visual analogue scale (VAS) pain score at 1 month. Major secondary endpoints were the treatment-failure rate, VAS pain scores at ≥ 2 months, and frequency-volume chart parameters.
RESULTS: Both TUF and TUF+HD showed significant improvement in VAS pain score at 1 month (95% confidence interval [CI]: - 1.62 to 0.16, P = 0.106). VAS pain scores were significantly lower in TUF+HD than TUF at 2 (95% CI: - 1.97 to - 0.28, P = 0.011), 4 (95% CI: - 2.83 to - 0.72, P = 0.002), and 6 (95% CI: - 3.11 to - 0.07, P = 0.040) months. Treatment-failure rate was higher in TUF (36.4%) than TUF+HD (17.4%), without significance (odds ratio: 2.714, 95% CI: 0.68 to 10.84, P = 0.189). Functional capacity and urgency were not significantly different between groups.
CONCLUSIONS: The addition of HD to TUF tended to be superior to TUF monotherapy for controlling pain in Hunner-type IC/BPS. This indicates that not only Hunner lesions but also normal-appearing background areas may have a role in the pain of IC/BPS.
BACKGROUND: ClinicalTrials.gov Identifier: NCT03987594, date of registration: 2019-06-17 (retrospectively registered).
方法:本随机对照试验纳入52例Hunner型IC/BPS患者,比例为1:1(TUF:TUF+HD)。在TUF+HD组中,在TUF之前在80cmH2O下进行HD8min。33名患者一直持续到6个月的观察期结束。主要终点是1个月时的视觉模拟评分(VAS)疼痛评分。主要次要终点是治疗失败率,≥2个月时的VAS疼痛评分,和频率-体积图参数。
结果:TUF和TUF+HD均显示1个月时VAS疼痛评分显著改善(95%置信区间[CI]:-1.62至0.16,P=0.106)。在2时,TUF+HD的VAS疼痛评分明显低于TUF(95%CI:-1.97至-0.28,P=0.011),4(95%CI:-2.83至-0.72,P=0.002),6个月(95%CI:-3.11至-0.07,P=0.040)。TUF的治疗失败率(36.4%)高于TUF+HD(17.4%),无显著性(比值比:2.714,95%CI:0.68至10.84,P=0.189)。两组之间的功能能力和紧迫性没有显着差异。
结论:在Hunner型IC/BPS中,在TUF中添加HD往往优于TUF单一疗法来控制疼痛。这表明,不仅Hunner病变,而且正常出现的背景区域也可能在IC/BPS的疼痛中起作用。
背景:ClinicalTrials.gov标识符:NCT03987594,注册日期:2019-06-17(回顾性注册)。