跳至主要内容
临床试验/CTRI/2024/06/069508
CTRI/2024/06/069508尚未招募不适用

Prevalence of Symptomatic pelvic organ prolapse in Belgavi district, India

KLE Academy of Higher Education and Research Belagavi1 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2024年9月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
1,500
试验地点
1
主要终点
Prevalence of symptomatic pelvic organ prolapse

研究概览

简要总结

Background

Pelvic organ prolapse (POP) is defined as “the descent of one or more aspects of the vagina and the uterus: the anterior vaginal wall, posterior vaginal wall, the uterus (cervix) or the apex of the vagina (vaginal vault or the cuff scare after hysterectomy. Women with early onset POP are generally asymptomatic while women with advanced POP often experience a palpable bulge in the vagina along with concurrent lower urinary tract and anorectal dysfunction. However, POP significantly affects women’s quality of life when the bulging interferes with normal sexual, urinary, or bowel function. Prevalence of POP is estimated to be 15% in low and middle-income countries.

Specific Aims:

Prevalence of symptomatic pelvic organ prolapse in women residing in Belagavi, India

Proportions of women who screen positive for prolapse associated pelvic floor dysfunction

a. Lower urinary tract dysfunction (urinary incontinence, voiding dysfunction)

b. Anorectal dysfunction (fecal incontinence, constipation syndromes)

c. Other

Current status of quality of life, awareness and knowledge, and care-seeking barriers among women with POP residing in Belagavi, India

Inclusion Criteria:

1.       All non-pregnant women at the age of 15 married women (past & present) above consenting to participate in the study.

Exclusion Criteria:

1.       All pregnant women.

Study Site: Women attending the community served by Primary Healthcare Centers (PHCs) managed by KAHER’s J N Medical College, Belagavi.

Sample size:

Estimated sample size 467 in the Belagavi catchment area based on prior  prevalence data and pilot study.

Methodology

1.       The study participants who screen positive for POP screening tool, will be provided with the option to undergo urogynecological examination by an obstetrics and gynecology resident, Urogynecology fellow, or obstetrician and gynecologist in a mobile unit, and will be referred for appropriate clinical management.

研究设计

研究类型
Observational

入排标准

年龄范围
15.00 Year(s) 至 75.00 Year(s)(—)
性别
Female

入选标准

  • All non-pregnant women at the age of 15, married women (past & present) above consenting to participate in the study.

排除标准

  • All pregnant women.

结局指标

主要结局

Prevalence of symptomatic pelvic organ prolapse

时间窗: At the time of evaluation

次要结局

  • Urinary incontinence(At the time of evaluation)
  • Voiding dysfunction(At the time of evaluation)

研究者

发起方
KLE Academy of Higher Education and Research Belagavi
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Rajan R Patil

J N Medical College, KLE Academy of Higher Education and Research, Belagavi

研究点 (1)

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