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临床试验/NCT06914791
NCT06914791Enrolling By Invitation不适用

Differential Rehabilitative Treatment for Pelvic Floor in Sportswoman: an Interventional Pilto Study Comparing Kegel and De Gasquet Approach

Alessandro Micarelli1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2025年4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
Enrolling By Invitation
发起方
入组人数
24
试验地点
1
主要终点
Pelvic Floor Distress Inventory (PFDI-20)

研究概览

简要总结

In this study at least 24 sportswoman (18-50 years old) will be recruited a randomized in two groups which will be differently treated for the following 8 weeks. one group will be treated with Kegel approach and the other one with De Gasquet apporach. before and after the treatment they will fill in a battery of falidated questionnaire in order to evaluate the improvement at pelvic floor level, quality of life and psychological distress.

详细描述

In this study at least 24 sportswoman (18-50 years old) with pelvic floow symptos (18-50 years old) will be recruited a randomized in two groups which will be differently treated for the following 8 weeks. They should havo no children, other relevant systemic disorders and assume no drugs. They should practice sports by at least one year.

one group will be treated with Kegel approach and the other one with De Gasquet apporach. before and after the treatment they will fill in a battery of falidated questionnaire in order to evaluate the improvement at pelvic floor level, quality of life and psychological distress. In partiqular they fill in:

  • Pelvic Floor Distress Inventory (PFDI-20)
  • Incontinence Severity Index (ISI)
  • Quality of life questionnaire (SF-36)
  • King's Health Questionnaire (KHQ)
  • Intestinal related symptoms questionnaire (ICIQ-B)
  • Depression Anxiety Stress Scale (DASS-21)

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
Single (Participant)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •practicing sports by at least one year

排除标准

  • •no systemic disorders
  • •no drugs assumption
  • •no children

研究组 & 干预措施

kegel arm

Active Comparator

干预措施: Kegel arm (Procedure)

De Gasquet arm

Experimental

干预措施: De Gasquet arm (Procedure)

结局指标

主要结局

Pelvic Floor Distress Inventory (PFDI-20)

时间窗: 8 weeks

Pelvic Floor Distress Inventory evalueates the pelvic floor distress with values ranging from 0 to 300 indicating respectively better and worse score

次要结局

  • Incontinence Severity Index (ISI)(8 weeks)
  • Quality of life questionnaire (SF-36)(8 weeks)
  • King's Health Questionnaire (KHQ)(8 weeks)
  • Intestinal related symptoms questionnaire (ICIQ-B)(8 weeks)
  • Depression Anxiety Stress Scale (DASS-21)(8 weeks)

研究者

发起方
Alessandro Micarelli
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Alessandro Micarelli

Scientific Director - Principal Investigator

Uniter Onlus

研究点 (1)

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