Abstract：
OBJECTIVE: In Hunner-type interstitial cystitis/bladder pain syndrome (IC/BPS), it is unclear whether suburothelial afferents underlying normal-appearing background areas contribute to symptom development. We examined whether adding hydrodistension (HD) to transurethral fulguration (TUF) of Hunner lesions, for the purpose of treating the background areas, is superior to TUF alone.
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).
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).
摘要：
目的：在Hunner型间质性膀胱炎/膀胱疼痛综合征（IC/BPS）中，目前尚不清楚在正常出现的背景区域基础的上皮下传入神经是否有助于症状的发展.我们检查了Hunner病变的经尿道电灼（TUF）是否增加了水力扩张（HD），为了处理背景区域，优于单独的TUF。
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）。
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）。
