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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Incontinence Impact Questionnaire IIQ 7:
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
- 是
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.
研究组 & 干预措施
Paula Exercises & Tibial Nerve Stimulation
Paula exercises involve contracting circular muscles of the body (especially facial muscles like the orbicularis oris and orbicularis oculi) to stimulate pelvic floor activity indirectly and for tibial stimulation Transcutaneous (TTNS) approach will be used
干预措施: Tibial Nerve Stimulation (Other)
Paula Exercises
Paula exercises involve contracting circular muscles of the body (especially facial muscles like the orbicularis oris and orbicularis oculi) to stimulate pelvic floor activity indirectly
干预措施: Paula Exercises (Other)
Paula Exercises & Tibial Nerve Stimulation
Paula exercises involve contracting circular muscles of the body (especially facial muscles like the orbicularis oris and orbicularis oculi) to stimulate pelvic floor activity indirectly and for tibial stimulation Transcutaneous (TTNS) approach will be used
干预措施: Paula Exercises (Other)
结局指标
主要结局
Incontinence Impact Questionnaire IIQ 7:
时间窗: 8th week
The Incontinence Impact Questionnaire (IIQ-7) is a brief, 7-item instrument used to assess the impact of urinary incontinence on a woman's quality of life.
Modified Oxford Scale
时间窗: 8th week
The Modified Oxford Scale is a clinical tool used to assess the strength of pelvic floor muscles through vaginal or rectal examination. It uses a 6-point scale (0 to 5), where 0 indicates no contraction and 5 represents a strong contraction. A Cronbach's alpha is not typically reported for this scale because it is based on a single-item, ordinal rating by a clinician, rather than a multi-item questionnaire
Female Sexual Function Index FSFI
时间窗: 8th week
The Female Sexual Function Index (FSFI) is a 19-item self-report questionnaire designed to assess six domains of female sexual function: desire, arousal, lubrication, orgasm, satisfaction, and pain. Each domain is scored individually and contributes to a total score that reflects overall sexual function, with higher scores indicating better function
SF 36
时间窗: 8th week
The Short Form-36 Health Survey (SF-36) is a widely used 36-item questionnaire designed to measure health-related quality of life across eight domainsThese domains contribute to two summary scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS).
次要结局
未报告次要终点