International urology and nephrology · 2025
Application study of pressure- and volume-controllable balloon in direct visualisation interstitial cystitis dilation surgery.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Wei Wei, Gao Chao, Wang Haibo, Yang Mingzhou, Wan Gang, Zhou Shiyao, Jiang Xingjin, Yang Jinyi
Аннотация
OBJECTIVE: 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.
METHODS: 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.
RESULTS: 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).
CONCLUSION: 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.
CLINICAL TRIAL REGISTRATION: ID:ISRCTN25030604, https://www.isrctn.com/ISRCTN25030604.
METHODS: 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.
RESULTS: 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).
CONCLUSION: 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.
CLINICAL TRIAL REGISTRATION: ID:ISRCTN25030604, https://www.isrctn.com/ISRCTN25030604.