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临床试验/NCT05630742
NCT05630742已完成不适用

Quality of Life Analysis in Bladder Pain Syndrome/Interstitial Cystitis: Implications for a Multimodal Integrated Treatment

Fondazione IRCCS Policlinico San Matteo di Pavia1 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2021年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
69
试验地点
1
主要终点
psychological symptoms and perception of pain affect every aspect of patients' life in IC

研究概览

简要总结

The aim of our study was to evaluate whether there is a higher prevalence of anxiety-depressive disorders in women with interstitial cystitis than in women with chronic non-neoplastic pain with or without fibromyalgia, to examine possible correlations between urological and psychiatric symptoms, analyze how urological symptoms affect psychological dimension, and how specific stress or trauma can contribute to the onset of interstitial cystitis.

详细描述

The survey included 69 patients, 42 patients had a diagnosis of Bladder Pain Syndrome/Interstitial Cystitis while 27 of them had chronic non-neoplastic pain. The comparison of the total values of the PHQ-9 between the two groups, 1 versus 2, in relation to final score of PHQ-9, the average PHQ-9 score was 10.3 in group 1, therefore a value greater than 9, considered as major depression (score between 10 and 14); the average score of PHQ-9 was 6.9 in group 2, as in sub-threshold depression (between 5-9). Correlation between PHQ-9 and BPI was also evaluated, the relation was significant only in interstitial cystitis with regard to the following spheres: daily life, work activity, pleasure of life, mood, sleep quality, pain intensity, and urinary symptoms. Based on these data, when PHQ-9 score increases, and depressive symptoms worsen, there is interference with daily life and work activity, pleasure of living, mood, quality of sleep, perception of intensity of pain and urinary symptoms. Patients who had onset of psychiatric symptoms following diagnosis (both interstitial cystitis and other painful syndromes) had an average PHQ-9 score of 11.7 compared to the score of 8.3 of patients without onset of psychiatric symptoms after diagnosis (p = 0.0464), so it may be that depressive symptoms starting after the diagnosis of pain syndrome are more severe. Women who undergo psychiatric-psychological consultation and therapy have an average O'Leary score 20.4 compared to 25.8 in those who are not under psychiatric consultation (p = 0.0418). This emphasizes how psychosocial support can improve perception of pain and urinary symptoms.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 82 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Female Patients aged > 18 years diagnosis of BPS/IC or chronic non-neoplastic pain

排除标准

  • bladder cancer

结局指标

主要结局

psychological symptoms and perception of pain affect every aspect of patients' life in IC

时间窗: 9 months

PHQ-9: to investigate psychological symptoms, O'Leary Saint (ICSI-ICPI) to investigate urological symptoms only for women with I.C and BPI questionnaires were administered

Examine whether there is a higher prevalence of anxiety-depressive disorders in women with interstitial cystitis than in women with chronic non-neoplastic pain with or without fibromyalgia.

时间窗: 9 months

PHQ-9: to investigate psychological symptoms, O'Leary Saint (ICSI-ICPI) to investigate

次要结局

  • correlations between urological symptoms and psychiatric symptoms(9 months)

研究者

发起方
Fondazione IRCCS Policlinico San Matteo di Pavia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniele Porru

MD

Fondazione IRCCS Policlinico San Matteo di Pavia

研究点 (1)

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