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临床试验/NCT05977231
NCT05977231招募中不适用

Evaluation of Efficacy of Conservative Treatments in Women With Urinary Incontinence

Mackay Medical College1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Urodynamic study (abdominal pressure)

研究概览

简要总结

To conduct a retrospective study to examine the effect of these conservative treatments to the symptoms and quality of life of patients with urinary incontinence. The investigators will use both subjective and objective assessment parameters, such as self-report symptoms, bladder diary, pad test and urodynamic study to access the improvement.

详细描述

Urinary incontinence is a common problem among women. The main types include stress incontinence, urge incontinence, and overflow incontinence. Other underlying pathology, such as cancer or neurologic disease can also cause urinary incontinence. To limit the medical expenses and possible complications of surgical treatment, the current treatment guidelines recommend conservative treatment as the first choice. According to American Urological Association (AUA)/Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU) guidelines, the first-line treatment for non-neurologic overactive bladder should be behavioral therapy, such as bladder training, water restriction, and pelvic floor muscle training, physiological feedback, pessary, etc. Bladder training aims to increase the time interval between voids, and to increase the bladder capacity by self-adjusted schedules. Pelvic floor muscle training strengthens the pelvic floor muscles to provide urethral support to prevent urine leakage and suppress urgency. There is strong evidence that pelvic floor muscle training is beneficial for stress urinary incontinence.

The second-line treatment is medication, including anticholinergic drugs and ß3 adrenoceptor-acting agents. Anticholinergic drugs can reduce bladder detrusor contraction, and ß3 adrenoceptor-acting agents can relax the detrusor and increase bladder capacity.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
20 Years 至 100 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Adult female patient diagnosed with urinary incontinence through clinical assessment
  • Diagnosed at Mackay Memorial Hospital and underwent non-surgical treatment and subsequent follow-up.

排除标准

  • Choosing invasive or surgical treatment options (such as bladder botulinum toxin injection, urethral sling surgery).
  • Unable to comply with regular follow-up for at least one year.
  • Pregnant women
  • Patients with a history of neuromuscular disorders.

结局指标

主要结局

Urodynamic study (abdominal pressure)

时间窗: form the baseline to the post-treatment measurement (about 6 month post)

abdominal pressure (cmH2O)

Urodynamic study (voided volume)

时间窗: from the baseline to the post-treatment measurement (about 6 month post)

voided volume (ml)

Questionaire (IIQ-7)

时间窗: from the baseline to the post-treatment measurement (about 6 month post)

incontinence impact questionnaire-7 (IIQ-7)

Urodynamic study (Infused volume)

时间窗: from the baseline to the post-treatment measurement (about 6 month post)

infused volume (ml)

Urodynamic study (intravesical pressure)

时间窗: form the baseline to the post-treatment measurement (about 6 month post)

intravesical pressure (cmH2O)

Urodynamic study (detrusor pressure)

时间窗: from the baseline to the post-treatment measurement (about 6 month post)

detrusor pressure (cmH2O)

Pad test

时间窗: from the baseline to the post-treatment measurement (about 6 month post)

The weight of Pad (g) before and after testing

Bladder diary (voiding volume)

时间窗: from the baseline to the post-treatment measurement (about 6 month post)

the daily voiding volume (ml)

Bladder diary (voiding frequency)

时间窗: from the baseline to the post-treatment measurement (about 6 month post)

the daily voiding frequency (times)

Questionaire (UDI-6)

时间窗: from the baseline to the post-treatment measurement (about 6 month post)

The urogenital distress inventory-6 (UDI-6)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chin-Tsung Shen

The Office of Research and Development staff

Mackay Medical College

研究点 (1)

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