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临床试验/NCT07762391
NCT07762391已完成不适用

The Effect of Pelvic Floor Muscle Exercise, Progressive Muscle Relaxation Exercise, and Their Combined Application on Comfort in Women With Stress Urinary Incontinence: A Four-Arm Parallel Randomized Controlled Trial

Karamanoğlu Mehmetbey University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年6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
已完成
发起方
入组人数
80
试验地点
1
主要终点
Change in Comfort Level

研究概览

简要总结

Stress urinary incontinence (SUI) is a common condition in women that causes involuntary urine leakage during activities such as coughing, sneezing, laughing, or exercising. This condition can negatively affect physical, emotional, and social well-being and reduce overall comfort. Pelvic floor muscle exercise (PFME) is the recommended first-line conservative treatment for SUI, while progressive muscle relaxation (PMR) may help reduce muscle tension and improve psychological well-being. However, the combined effects of these two interventions on comfort have not been well studied.

This randomized controlled trial aims to compare the effects of PFME, PMR, their combined application, and routine care on comfort in women with stress urinary incontinence. Participants will be randomly assigned to one of four study groups and followed for six weeks. Comfort will be assessed at baseline and at Weeks 2, 4, and 6 using a validated questionnaire. The findings are expected to provide evidence for improving conservative treatment strategies and enhancing patient-centered care for women with stress urinary incontinence.

详细描述

Stress urinary incontinence (SUI) is the most common type of urinary incontinence among women and is characterized by the involuntary leakage of urine during activities that increase intra-abdominal pressure, such as coughing, sneezing, laughing, exercising, or lifting heavy objects. Beyond urinary symptoms, SUI has substantial physical, psychological, social, and economic consequences that adversely affect women's daily functioning and overall well-being. Although pelvic floor muscle exercise (PFME) is recommended as the first-line conservative treatment for women with SUI, treatment outcomes may be influenced by factors such as exercise adherence, psychological stress, anxiety, and impaired neuromuscular coordination.

Progressive muscle relaxation (PMR) is a structured behavioral intervention that aims to reduce muscle tension and psychological stress through the sequential contraction and relaxation of major muscle groups. Previous studies have demonstrated beneficial effects of PMR on anxiety, stress-related symptoms, and muscle relaxation. Because psychological factors may contribute to pelvic floor dysfunction and symptom perception, combining PFME with PMR may enhance the effectiveness of conservative rehabilitation by addressing both physical and psychophysiological mechanisms. However, evidence regarding the combined effects of these interventions on patient comfort remains limited.

This study was designed as a prospective, four-arm, parallel-group randomized controlled trial conducted at the Urology Outpatient Clinic of Karaman Training and Research Hospital, Karaman, Türkiye. Eligible women diagnosed with stress urinary incontinence were randomly allocated to one of four study groups: (1) pelvic floor muscle exercise (PFME), (2) progressive muscle relaxation (PMR), (3) combined PFME and PMR, or (4) routine outpatient care (control). Participants in the intervention groups followed standardized home-based exercise programs for six weeks after receiving individualized education from a Physical Medicine and Rehabilitation specialist. Adherence to the intervention was supported through weekly telephone follow-up and reminder messages.

The primary objective of the trial was to compare changes in comfort among the four study groups over the six-week intervention period. Comfort was selected as the primary patient-centered outcome because it reflects physical, psychospiritual, sociocultural, and environmental well-being as described in Kolcaba's Comfort Theory. The findings of this study are expected to contribute to the evidence supporting conservative management strategies for stress urinary incontinence and to determine whether integrating progressive muscle relaxation into pelvic floor rehabilitation provides additional clinical benefit beyond conventional pelvic floor muscle training alone.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

盲法说明

This was an open-label trial because the nature of the exercise interventions did not permit blinding of participants or intervention providers. Outcome assessments were performed using standardized procedures to ensure consistency across all study groups.

入排标准

年龄范围
45 Years 至 55 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Female participants aged 45-55 years Diagnosis of stress urinary incontinence Turkish-speaking Literate Access to the internet Access to a smartphone No active urinary tract infection Not pregnant No neurological or cognitive disorder

排除标准

  • •Previous participation in pelvic floor muscle exercise (PFME) or progressive muscle relaxation (PMR) training programs.
  • •Withdrawal from the study after enrollment.

研究组 & 干预措施

Routine Care (Control)

No Intervention

Routine Care (Control)

Pelvic Floor Muscle Exercise (PFME)

Experimental

Pelvic Floor Muscle Exercise (PFME)

干预措施: Pelvic Floor Muscle Exercise (Behavioral)

Progressive Muscle Relaxation (PMR)

Experimental

Progressive Muscle Relaxation (PMR)

干预措施: Progressive Muscle Relaxation (PMR) (Behavioral)

Combined PFME + PMR

Experimental

Combined PFME + PMR

干预措施: Combined Pelvic Floor Muscle Exercise and Progressive Muscle Relaxation (Behavioral)

结局指标

主要结局

Change in Comfort Level

时间窗: Baseline, Week 2, Week 4, and Week 6

To evaluate the effect of pelvic floor muscle exercises, progressive muscle relaxation exercises, and their combined application on comfort levels in women with stress urinary incontinence. Comfort level was assessed using the Urinary Incontinence and Frequency Comfort Questionnaire (UIFCQ).

次要结局

未报告次要终点

研究者

发起方
Karamanoğlu Mehmetbey University
申办方类型
Other
责任方
Principal Investigator
主要研究者

GAMZE GOKE ARSLAN

Assistant Professor

Karamanoğlu Mehmetbey University

研究点 (1)

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