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
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.
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.
Inclusion Criteria: 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
Exclusion Criteria: Previous participation in pelvic floor muscle exercise (PFME) or progressive muscle relaxation (PMR) training programs. Withdrawal from the study after enrollment.
[{"measure":"Change in Comfort Level","timeFrame":"Baseline, Week 2, Week 4, and Week 6"}]