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临床试验/NCT05719584
NCT05719584已完成不适用

Effects of Pelvic Floor Muscle Training With and Without Hypopressive Exercises on Pelvic Organ Prolapse in Postmenopausal Females.

Riphah International University2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2022年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
2
主要终点
Pelvic Floor Impact Questionnaire-7 (PFIQ-7)

研究概览

简要总结

To compare the effects of pelvic floor muscle training with and without hypopressive exercises on pelvic organ prolapse in postmenopausal females

详细描述

In this randomized controlled trial multigravida, postmenopausal females with stage 1 and 2 pelvic organ prolapse will be taken (exclusion criteria includes cesarean section females, ovarian cysts ,UTIs and neoplasm). This study will be conducted in Jinnah hospital , Lahore. Sample size of 36 will be taken according to inclusion criteria. Study will be completed in 10 months after approval of synopsis. Non-Probability convenient sampling will be used. A written consent form will be taken from participants meeting inclusion criteria and will be randomly allocated into two groups through lottery method, to either the Pelvic floor muscle training group or group with combined pelvic floor muscle exercise and hypopressive exercise. Treatment period will be 12 weeks 3 days per week. The participants will be advised not to use other forms of treatment during the trial (pharmacologic or non pharmacologic treatment). All subjects will be assessed before and after treatment by POP-Q, pelvic floor impact questionnaire and P-QOL. Data will be analyzed by using SPSS 25 statistical software.

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
None

入排标准

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

入选标准

  • Multigravida
  • Previous spontaneous vaginal deliveries
  • Diagnosed Stage 1 and 2 pelvic organ prolapse
  • Post-menopausal females

排除标准

  • History of cesarean section
  • History of ovarian cysts
  • History of UTIs
  • History of neoplasm
  • Instrumental deliveries

研究组 & 干预措施

hypopressive exercises

Experimental

pelvic floor muscle exercises along with hypopressive exercises

干预措施: hypopressive exercises (Other)

hypopressive exercises

Experimental

pelvic floor muscle exercises along with hypopressive exercises

干预措施: pelvic floor muscle training (Other)

pelvic floor muscle training

Active Comparator

pelvic floor muscle exercises alone

干预措施: pelvic floor muscle training (Other)

结局指标

主要结局

Pelvic Floor Impact Questionnaire-7 (PFIQ-7)

时间窗: 12th week

It is a short and less comprehensive version of Pelvic Floor Impact Questionnaire (PFIQ). It is a health related questionnaire for women with pelvic floor conditions. consists of 7 questions that need to be answered 3 times each.

pelvic organ prolapse quantification (POP-Q)

时间窗: 12th week

POP-Q can be seen in Many clinical settings \& published researches and it is used to grade and measure of pelvic organ prolapse during its assessment.

Prolapse Quality of life questionnaire(P-QOL)

时间窗: 12th week

A simple, valid, reliable questionnaire to assess the severity of symptoms and their impact on the quality of life in women with Pelvic organ prolapse. There are several questions which a participant needs to answer.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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