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临床试验/NCT06260436
NCT06260436招募中不适用

Questionnaire About The Incidence of Lower Urinary Tract Symptoms Among a Sample of Women Before and After Surgical Correction of Uterine Prolapse and Impact on Quality of Life

Assiut University1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2021年5月30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
180
试验地点
1
主要终点
effect of surgical correction of pelvic organ prolapse on the lower urinary tract symptoms

研究概览

简要总结

. The study will include patients who underwent Pelvic reconstructive surgery for advanced pelvic organ prolapse (POP-Q ≥ 3). Data regarding preoperative evaluation, surgical procedure, and post-operative management will be collected. women will receive a follow up questionnaire. . The baseline questionnaire included data on age, urinary incontinence, daytime frequency, nocturia, postmicturition dribble, straining, urgency, incomplete bladder emptying, and hesitancy. Women were asked about leakage caused by coughing or sneezing, moving, lifting, sleeping, sexual intercourse, urgency, and rest.

详细描述

Pelvic organs prolapse (POP) is defined as the downward descent of the pelvic organs resulting in protrusion of the vagina and/or uterine cervix. POP and overactive bladder (OAB) often co-exist. The International Continence Society defines OAB as "urgency with or without urge incontinence, usually with frequency and nocturia" Of women with symptomatic pelvic organ prolapse, 13-39% experience voiding dysfunction (VD).

The aim of the study is to determine the effect of prolapse surgery on voiding function. The study will include patients who underwent Pelvic reconstructive surgery for advanced pelvic organ prolapse (POP-Q ≥ 3). Data regarding preoperative evaluation, surgical procedure, and post-operative management will be collected. women will receive a follow up questionnaire.

Non-responders will send a reminder after three weeks and if the non-responders still failed to respond were eventually asked to complete a short form comprising questions on urgency and incontinence. This procedure followed guidelines outlined by the local ethical committee. The baseline questionnaire included data on age, urinary incontinence, daytime frequency, nocturia, postmicturition dribble, straining, urgency, incomplete bladder emptying, and hesitancy. Women were asked about leakage caused by coughing or sneezing, moving, lifting, sleeping, sexual intercourse, urgency, and rest. stress incontinence according to the International Continence Society defined as leakage caused by exertion (coughing or sneezing, moving, or lifting) and urge incontinence as leakage associated with urgency.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

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

  • Age; greater than or equal to 18 years
  • women with urogenital prolapse grade 3 or more
  • indicated for surgical repair for pelvic organ prolapse
  • Willing and able to sign an informed consent
  • Willing to comply with the study protocol

排除标准

  • Anti-incontinence surgery
  • Lower urinary tract anomaly
  • Active urinary tract infections
  • Bladder tumor.
  • Bladder stones

结局指标

主要结局

effect of surgical correction of pelvic organ prolapse on the lower urinary tract symptoms

时间窗: 3 months

the effect of surgical correction of pelvic organ prolapse on the lower urinary tract symptoms will be checked through a validated questionnaire before and after surgical correction

次要结局

  • effect of surgical correction of pelvic organ prolapse on the quality of life(3 months)

研究者

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

Tharwat Gamal Mohammed Ibrahim

principal investigator

Assiut University

研究点 (1)

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