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临床试验/NCT06521008
NCT06521008已完成不适用

Effect of Diaphragmatic Training on Urgency Urinary Incontinence in Postmenopausal Women

Cairo University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年7月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
assessing the change in Urodynamics (first desire to void)

研究概览

简要总结

The purpose of this study was to determine the effect of diaphragmatic training on urgency urinary incontinence in postmenopausal women.

详细描述

Urgency urinary incontinence affects 9-13% of women, increasing with age and impacting daily activities, quality of life, depression, and social isolation. It is a significant source of dependency among the elderly and a factor in nursing home admissions. Untreated incontinence can lead to falls, infections, and loss of independence. Conservative management is the first-line therapy, but pelvic floor muscle training is a potential treatment method. This study aims to evaluate the effectiveness of diaphragmatic training on urinary incontinence in postmenopausal women.

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
55 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Postmenopausal women suffer from UUI.
  • They will be multipara more than
  • Their age will range from 55-65 years old.
  • Their body mass index (BMI) will range from 25-29.9 kg/m2..
  • They will experience menopause at least for 3 years.

排除标准

  • Urinary tract infection
  • Previous surgery for urinary incontinence
  • Upper motor neuron diseases
  • History of genito-urinary cancer
  • Previous pelvic irradiation
  • Pure stress urinary incontinence
  • Genital prolapse
  • Diabetes mellitus
  • Pace maker

研究组 & 干预措施

Selctive drugs

Experimental

consists of 20 women. They will receive selective anti Muscarinic drugs (5-10 mg) once per day for 12 weeks and instructions including bladder retraining.

干预措施: anti muscarinic drugs (Drug)

Selctive drugs

Experimental

consists of 20 women. They will receive selective anti Muscarinic drugs (5-10 mg) once per day for 12 weeks and instructions including bladder retraining.

干预措施: Instructions including bladder training (Other)

Pelvic floor and abdominal strengthening

Experimental

consists of 20 women. They will receive the same treatment in group (A), pelvic floor muscle training (PFMT) and abdominal strengthening 3 sessions/week for 12 weeks.

干预措施: anti muscarinic drugs (Drug)

Pelvic floor and abdominal strengthening

Experimental

consists of 20 women. They will receive the same treatment in group (A), pelvic floor muscle training (PFMT) and abdominal strengthening 3 sessions/week for 12 weeks.

干预措施: Instructions including bladder training (Other)

Pelvic floor and abdominal strengthening

Experimental

consists of 20 women. They will receive the same treatment in group (A), pelvic floor muscle training (PFMT) and abdominal strengthening 3 sessions/week for 12 weeks.

干预措施: pelvic floor muscle training (PFMT) (Other)

Pelvic floor and abdominal strengthening

Experimental

consists of 20 women. They will receive the same treatment in group (A), pelvic floor muscle training (PFMT) and abdominal strengthening 3 sessions/week for 12 weeks.

干预措施: abdominal exercise (Other)

diaphragmatic training

Experimental

consists of 20 women. They will receive the same treatment in group (B), in addition to diaphragmatic training 3 sessions/week for 12 weeks.

干预措施: anti muscarinic drugs (Drug)

diaphragmatic training

Experimental

consists of 20 women. They will receive the same treatment in group (B), in addition to diaphragmatic training 3 sessions/week for 12 weeks.

干预措施: Instructions including bladder training (Other)

diaphragmatic training

Experimental

consists of 20 women. They will receive the same treatment in group (B), in addition to diaphragmatic training 3 sessions/week for 12 weeks.

干预措施: Diaphragmatic Training (Other)

结局指标

主要结局

assessing the change in Urodynamics (first desire to void)

时间窗: up to 12 weeks

The study used a double-lumen cytometry catheter to diagnose involuntary detrusor contractions in women. The catheter measured the change in urodynamics in form of volume at first desire to void, for each woman in all groups. The urodynamic method is a reliable and mandatory method for diagnosing and treating UUI symptoms, as relying solely on urinary symptoms may lead to under-diagnosis of detrusor overactivity.

assessing the change in Urodynamics (first sensation of bladder filling)

时间窗: up to 12 weeks

The study used a double-lumen cytometry catheter to diagnose involuntary detrusor contractions in women. The catheter measured the change in urodynamics in form of first sensation of bladder filling, for each woman in all groups.

assessing the change in Urodynamics (maximum bladder capacity)

时间窗: up to 12 weeks

The study used a double-lumen cytometry catheter to diagnose involuntary detrusor contractions in women. The catheter measured the change in urodynamics in form of maximum bladder capacity, for each woman in all groups.

次要结局

  • assessing the change in bladder ascending movement(up to 12 weeks)
  • assessing the change in weight and height(up to 12 weeks)
  • assessing the change in Urinary function(up to 12 weeks)
  • assessing the change in body mass index(up to 12 weeks)

研究者

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

Sandy Samir Hassan Darweesh

Principal Investigator

Cairo University

研究点 (1)

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