Wei Wei, Gao Chao, Wang Haibo, Yang Mingzhou, Wan Gang, Zhou Shiyao, Jiang Xingjin, Yang Jinyi
Department of Urology, Affiliated Dalian Municipal Friendship Hospital of Dalian Medical University, Dalian, 116001, Liaoning, China.
, Dalian, China.
Int Urol Nephrol. 2025 Aug 16. doi: 10.1007/s11255-025-04706-9.
This study aimed to evaluate the efficacy and safety of pressure- and volume-controlled balloon dilation in the treatment of interstitial cystitis/bladder pain syndrome (IC/BPS) and to compare it with traditional bladder hydrodistension to explore a superior therapeutic approach.
A prospective randomised-controlled trial was conducted, enrolling 50 women with IC/BPS aged 52-77 years, treated between July 2013 and June 2023. Patients were randomly assigned to a pressure- and volume-controlled balloon dilation group (experimental group, n = 25) or a traditional bladder hydrodistension group (control group, n = 25). The primary outcome measures included interstitial cystitis symptom index and interstitial cystitis problem index (ICSI/ICPI) scores, pelvic pain and urinary frequency (PUF) scores, bladder capacity, nocturnal urination frequency, maximum voided volume, and postoperative complications (bleeding and bladder rupture). Statistical analyses were performed using t tests, Wilcoxon rank-sum tests, and Chi-square tests, with P < 0.05 indicating statistical significance.
At 6 months post-treatment, the experimental group showed significantly lower ICSI/ICPI scores than the control group (P < 0.05). The experimental group also exhibited significantly lower PUF scores at all time points (P < 0.05). Under non-anaesthetic conditions, the experimental group demonstrated significantly greater bladder capacity (P < 0.05), whereas no significant difference was observed under anaesthetic conditions (P > 0.05). The experimental group experienced significantly fewer episodes of nocturnal urination from 2 weeks to 6 months post-treatment (P < 0.05).
Pressure- and volume-controlled balloon dilation demonstrated superior efficacy in alleviating IC/BPS symptoms and improving bladder function compared with traditional hydrodistension. Additionally, it was associated with a lower complication rate, offering a safer and more effective therapeutic option for patients with IC/BPS.
ID:ISRCTN25030604, https://www.isrctn.com/ISRCTN25030604.
本研究旨在评估压力和容量控制球囊扩张术治疗间质性膀胱炎/膀胱疼痛综合征（IC/BPS）的疗效和安全性，并将其与传统膀胱水扩张术进行比较，以探索更优的治疗方法。
进行了一项前瞻性随机对照试验，纳入2013年7月至2023年6月期间治疗的50例年龄在52 - 77岁的IC/BPS女性患者。患者被随机分配到压力和容量控制球囊扩张组（实验组，n = 25）或传统膀胱水扩张组（对照组，n = 25）。主要结局指标包括间质性膀胱炎症状指数和间质性膀胱炎问题指数（ICSI/ICPI）评分、盆腔疼痛和尿频（PUF）评分、膀胱容量、夜尿频率、最大排尿量以及术后并发症（出血和膀胱破裂）。采用t检验、Wilcoxon秩和检验和卡方检验进行统计分析，P < 0.05表示具有统计学意义。
治疗后6个月，实验组的ICSI/ICPI评分显著低于对照组（P < 0.05）。实验组在所有时间点的PUF评分也显著更低（P < 0.05）。在非麻醉条件下，实验组的膀胱容量显著更大（P < 0.05），而在麻醉条件下未观察到显著差异（P > 0.05）。治疗后2周 至6个月，实验组的夜尿发作次数显著更少（P < 0.05）。
与传统水扩张术相比，压力和容量控制球囊扩张术在缓解IC/BPS症状和改善膀胱功能方面显示出更优的疗效。此外，其并发症发生率更低，为IC/BPS患者提供了一种更安全有效的治疗选择。
ID：ISRCTN25030604，https://www.isrctn.com/ISRCTN25030604 。
