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临床试验/NCT01879930
NCT01879930终止4 期

Chronic Bladder Pain Syndrome in Women: Can Doxycycline Help? A Prospective, Randomised,Placebo-controlled, Double-blind Study

Insel Gruppe AG, University Hospital Bern1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2012年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
入组人数
5
试验地点
1
主要终点
Change in the O'Leary-Sant IC symptom and problem index total score from baseline

研究概览

简要总结

Chronic bladder pain syndrome is a chronic disabling disorder characterized by chronic pelvic pain, pressure or discomfort perceived to be related to the urinary bladder accompanied by at least one other urinary symptom such as persistent urgency or frequency in the absence of an identifiable cause. Chronic bladder pain syndrome severely decreases an individual's quality of life and represents a significant financial burden to those affected by it. Currently, multifactorial pathogenesis is assumed including endocrine-involvement, pelvic floor muscle irregularities, immunologic aspects and chemical causes. Corresponding to the wide spectrum of presumptive triggers, a large number of therapeutic approaches are propagated, however most are associated with limited effectiveness. Thus, treatment of BPS is a challenge and the ideal therapy remains to be elucidated. Microorganisms such as Chlamydia trachomatis, Ureaplasma urealyticum and Mycoplasma genitalium remains a challenge so that these organisms may well be involved in the pathogenesis of chronic bladder pain syndrome. The investigators hypothesise that doxycycline orally for 4 weeks, including therapy of the sexual partner, can significantly relieve symptoms in women with chronic bladder pain syndrome

详细描述

Background

Doxycycline is used to treat bacterial infections. Doxycycline is in a class of medications called tetracycline antibiotics. In addition to the general indications for all members of the tetracycline antibiotics group, doxycycline is frequently used to treat chronic prostatitis and pelvic inflammatory disease. Especially intracellular agents, such as chlamydia, are generally susceptible to doxycycline. Assuming this infection to be responsible for the chronic bladder pain syndrome in women, therapy will be performed in accordance with the authorised indication and dosage.Bacterial cystitis is an exclusion criterion for the diagnosis of chronic bladder pain syndrome. However, the detection of microorganisms such as Chlamydia trachomatis, Ureaplasma urealyticum and Mycoplasma genitalium remains a challenge so that these organisms may well be involved in the pathogenesis of chronic bladder pain syndrome. This is supported by the findings of our retrospective study1 that doxycycline orally for 4 weeks including therapy of the sexual partner lead to a reduction of symptoms in 71% of women complaining of persistent urgency and frequency, chronic urethral and/or bladder pain. Therefore, doxycycline therapy is sensible, especially considering that there are only a few, costly and often little effective symptomatic other treatment options.

Thus, we aim to investigate the effectiveness of doxycycline in women with chronic bladder pain syndrome in a prospective, randomised, placebo-controlled, double-blind study.

Chronic bladder pain syndrome is a chronic disabling disorder characterized by chronic pelvic pain, pressure or discomfort perceived to be related to the urinary bladder accompanied by at least one other urinary symptom such as persistent urgency or frequency in the absence of an identifiable cause2. In Europe, prevalence rates in women range from 306 to 450/100'0003,4 - much higher than previously estimated. Thus, chronic bladder pain syndrome is a serious economic problem for every health care system. In addition, chronic bladder pain syndrome severely decreases an individual's quality of life and represents a significant financial burden to those affected by it. Currently, multifactorial pathogenesis is assumed including endocrine-involvement, pelvic floor muscle irregularities, immunologic aspects and chemical causes. Corresponding to the wide spectrum of presumptive triggers, a large number of therapeutic approaches are propagated, however most are associated with limited effectiveness. Thus, treatment of BPS is a challenge and the ideal therapy remains to be elucidated. We hypothesise that doxycycline orally for 4 weeks, including therapy of the sexual partner, can significantly relieve symptoms in women with chronic bladder pain syndrome.

Objective

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

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

入选标准

  • Bladder pain / suprapubic pressure or discomfort for >6months
  • Urgency/urgency incontinence and/or frequency for >6months
  • Written informed consent (including confirmation that the partner will also be treated and that during the treatment period sexual intercourse is only allowed using condoms)
  • Exclusion Criteria
  • age < 18 years
  • Tetracycline allergy
  • Intake of a tetracycline in the last 3 months
  • pregnancy
  • breast feeding
  • bacterial cystitis in the last 4 weeks
  • urethral/vaginal/cervical/uterine and/or rectal cancer
  • chemical cystitis
  • tuberculous cystitis
  • benign or malignant bladder tumors
  • Lack of radiologic exclusion of pelvic pathology

排除标准

  • 未提供

研究组 & 干预措施

doxycycline

Active Comparator

Zadorin-100® (doxycycline), licence number Swissmedic: 43051 Legal holder: Mepha Pharma AG, Aesch/BL

干预措施: doxycycline (Drug)

placebo

Placebo Comparator

Placebo Galepharm Composition: lactose monohydrate, ceolus PH 102, croscarmellose sodium, magnesiumstearat, manufacturer: Pharmacy Hotz, 8700 Küsnacht, Switzerland

干预措施: placebo (Drug)

结局指标

主要结局

Change in the O'Leary-Sant IC symptom and problem index total score from baseline

时间窗: 4, 8 , 24 weeks

次要结局

  • Changes of patient reported pain, urgency, frequency, functional bladder capacity documented in 72-hour pain and bladder diary, completed during the 3 days before the particular follow-up visit.(4, 8, 24 weeks)
  • Changes in sexual function assessed by the Female Sexual Function Index (FSFI) at the time of the particular follow-up visit(4, 8, 24 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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