Comparison of the Effects of Pelvic Floor Strengthening and Relaxation Exercises Delivered Via Telerehabilitation in Women Diagnosed With Multiple Sclerosis: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- 24 Hours Voiding Diary
研究概览
简要总结
The aim of this study was to compare the effects of pelvic floor strengthening and relaxation exercises on lower urinary tract dysfunction (LUTD), depression and quality of life (QoL) in women with Multiple Sclerosis (WwMS). The main questions it aims to answer are:
- Are pelvic floor relaxation exercises effective on lower urinary tract dysfunction (LUTD)?
- Is there a difference in the effect on LUTD symptoms between pelvic floor strengthening exercises and relaxation exercises? Participants were divided into three groups: pelvic floor strengthening, relaxation and combined (both pelvic floor strengthening and relaxation together) exercise groups. Participants were called every week for 8 weeks and an online session was held one day per week. Participants were asked to perform the exercises 3 times a day, every other day. Urogenital Distress Inventory (UDI-6), Incontinence Impact Questioonaire (IIQ-7), International Consultation on Incontinence Questionnaire-Short form (ICIQ-SF), Overactive Bladder Assessment Form (OAB-V8), 24-Hour Voiding Diary and Patient Health Questionnaire (PHQ) were used to evaluate.
详细描述
In MS, neurogenic bladder and lower urinary tract dysfunctions (LUTD) are common symptoms observed in approximately 75% of people with Multiple Sclerosis (PwMS) . Untreated urinary dysfunctions may lead to lower urinary tract infections, renal damage, emotional stress, sleep disturbances, social isolation, and a decline in quality of life (QoL) 6, 7. To manage neurogenic LUTD, the conservative treatment approaches constitute the first-line therapy for symptoms. Pelvic floor muscle exercises (PFME) have important role for treatment of urinary incontinence (UI) and neurogenic LUTD. Tension and spasm in the pelvic floor muscles (PFM) can lead to a variety of symptoms that negatively impact QoL, including voiding dysfunction, pain, sexual dysfunction, and anorectal disorders. Inadequate relaxation of the pelvic floor during micturition may result in symptoms such as urinary frequency, post-void residual urine, urgency, increased daytime voiding, and urge UI. Therefore, relaxation exercises targeting the PFM, as well as comprehensive pelvic floor rehabilitation, can be utilized in the management of these symptoms While PFM strengthening protocols have been utilized in the management of neurogenic LUTD in women with MS (WwMS), there is currently no therapeutic program in the literature that combines both relaxation and strengthening exercises applied simultaneously to the PFM. This study aims to evaluate the effects of a combined exercise protocol-targeting both relaxation and strengthening of the PFM-on neurogenic LUTD and depression in WwMS.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participants were eligible to participate if they:
- •were female and aged 18 years or older,
- •had a score of less than 6.5 on the Expanded Disability Status Scale (EDSS) and were ambulatory,
- •experienced neurogenic LUTD such as urgency, urge UI, urinary frequency, and nocturia,
- •had normal cognitive function, defined as a score above 24 on the Standardized Mini-Mental State Examination (SMMSE)-Turkish version.
排除标准
- •Participants were excluded if they:
- •had spasticity in the lower extremity muscles, particularly in the adductors,
- •experienced an MS relapse within the previous two months,
- •had a current urinary tract infection,
- •were pregnant,
- •had undergone urogynecological surgery within the past six months,
- •lacked access to or the ability to use tools required for telerehabilitation (e.g., internet, camera, microphone, or smartphone).
结局指标
主要结局
24 Hours Voiding Diary
时间窗: From enrollment to the end of treatment at 8 weeks.
Patients were instructed to void into the container for 24 hours and record the volume of each urination. They were also asked to document all fluid intake, episodes of urgency, and any occurrences of UI.
次要结局
- Urogenital Distress Inventory (UDI-6)(From enrollment to the end of treatment at 8 weeks)
- Overactive Bladder Assessment Form (OAB-V8)(From enrollment to the end of treatment at 8 weeks)
- Patient Health Questionnaire (PHQ)(From enrollment to the end of treatment at 8 weeks.)
- Incontinence Impact Questionnaire (IIQ-7)(From enrollment to the end of treatment at 8 weeks.)
- International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)(From enrollment to the end of treatment at 8 weeks.)