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临床试验/NCT07576205
NCT07576205招募中不适用

Combine Effects of Paula Exercises and Tibial Nerve Stimulation on Incontinence, Pelvic Floor Muscles Strength, Sexual Function and Quality of Life in Stress Urinary Incontinence

Riphah International University1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2025年10月1日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
52
试验地点
1

研究概览

简要总结

The aim of this study is to compare the combined effects of Paula method & tibial nerve stimulation on incontinence, pelvic floor muscles strength, sexual function and quality of life in stress urinary incontinence

详细描述

This study will be randomized controlled trial and will be conducted in Arshian Hussnain Medical Clinic and at Marie Stopes Society. Non probability convenience sampling technique will be used and 56 participants will be recruited in study after randomization. Inclusion criteria will be females aged 30-45 years, multiparous women (≥2 full-term vaginal delivery). Exclusion criteria will be Neurological disorders, pregnancy and dermatological conditions .The subjects will be divided into two groups. Group A will receive Paula exercise and Tibial nerve stimulation. Group B will receive only Paula exercises. Both groups will receive baseline treatment which will include pelvic floor muscle contractions. The total duration of treatment will be 8 weeks and there will be 2 sessions each week. Outcomes assessed will be urinary function, pelvic floor muscles strength, sexual function & quality of life. Outcomes will be assessed using validated tools such as the IIQ-7, Modified Oxford Scale, FSFI, and SF-36. After data collection, it will be analyzed by using SPSS version 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 (Outcomes Assessor)

入排标准

年龄范围
30 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Multiparous women (≥2 full-term vaginal deliveries)
  • Clinical diagnosis of stress urinary incontinence (confirmed by cough stress test)
  • Duration of symptoms ≥3 months
  • Ability to correctly perform pelvic floor contractions (confirmed by digital examination)

排除标准

  • Neurological disorders (e.g., multiple sclerosis, spinal cord injury)
  • Mixed or urge urinary incontinence as the predominant type
  • Previous pelvic surgery or incontinence-related procedures within the past year
  • Current pregnancy or <6 months postpartum
  • Pelvic organ prolapse beyond stage II (POP-Q system)
  • Current use of other incontinence therapies (e.g., medication, PTNS, PFMT)
  • Diagnosed malignancy
  • Diagnosed psychiatric disorder
  • Pregnancy
  • Diagnosed dermatological condition
  • Participants who are currently enrolled in other clinical trials to avoid potential confounding factors.

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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