NCT07482696

Electromyographic Biofeedback Therapy in Patients With Dyssynergic Defecation

Effects of Game-Based Electromyographic Biofeedback Therapy on Quality of Life and Sleep Quality in Patients With Dyssynergic Defecation

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Kocaeli University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study aimed to investigate the effects of game-based electromyographic (EMG) biofeedback therapy on the quality of life and sleep quality of individuals diagnosed with dyssynergic defecation.

Detailed description

This study aimed to investigate the effects of game-based electromyographic (EMG) biofeedback therapy on quality of life, sleep quality, constipation severity, and pelvic floor muscle function in individuals diagnosed with dyssynergic defecation and chronic constipation. Dyssynergic defecation is a common functional defecation disorder and is one of the leading causes of chronic constipation. It is characterized by paradoxical contraction or inadequate relaxation of the pelvic floor muscles and anal sphincters during defecation, resulting in impaired evacuation of the rectum. This condition leads to excessive straining, a sensation of incomplete evacuation, prolonged stool retention, and significant deterioration in quality of life. Epidemiological studies indicate that dyssynergic defecation accounts for a substantial proportion of chronic constipation cases referred to tertiary care centers for treatment. In patients with dyssynergic defecation, pharmacological treatments alone are often insufficient because they do not address the underlying neuromuscular coordination disorder. Therefore, contemporary management strategies emphasize behavioral and rehabilitative interventions aimed at retraining pelvic floor muscle coordination in women with UI. Among these approaches, EMG biofeedback therapy has emerged as one of the most effective and evidence-based treatment modalities for this condition. Previous randomized controlled trials have demonstrated that EMG biofeedback improves defecation dynamics, reduces constipation-related symptoms, and provides sustained benefits compared with conventional treatment. Despite its proven efficacy, conventional EMG biofeedback therapy may be limited by reduced patient motivation, difficulty in understanding abstract muscle activity patterns, and decreased adherence. In recent years, game-based biofeedback systems have been introduced to overcome these limitations by enhancing patient engagement and facilitating the motor learning process. Game-based biofeedback integrates real-time visual feedback with interactive tasks, allowing patients to actively control on-screen elements through appropriate muscle activation and relaxation. This approach supports motor learning principles, promotes neuromuscular adaptation, and may improve treatment compliance in patients. Another important but often overlooked consequence of chronic constipation and dyssynergic defecation is the impaired sleep quality. Persistent abdominal discomfort, bloating, and defecation-related anxiety can negatively affect sleep patterns, leading to fatigue, reduced daytime functioning, and further deterioration in quality of life (QoL). However, limited data are available on the effects of pelvic floor rehabilitation and biofeedback therapy on sleep quality in this patient population. In recent years, increasing attention has been given to the role of objective physiological assessments in evaluating the efficacy of treatments. Anorectal manometry provides quantitative information on anorectal motility and pelvic floor muscle coordination and is considered the gold standard for diagnosing of dyssynergic defecation. The inclusion of objective manometric measurements alongside patient-reported outcomes allows for a comprehensive evaluation of both the clinical and physiological responses to treatment. Therefore, this randomized controlled study aimed to evaluate the short- and mid-term effects of game-based EMG biofeedback therapy, applied in addition to standard pelvic floor rehabilitation, compared with sham EMG biofeedback in individuals with dyssynergic defecation. The primary outcome of this study was the change in quality of life, assessed using the Patient Assessment of Constipation-Quality of Life (PAC-QOL) questionnaire. Secondary outcomes included sleep quality, constipation severity, defecation patterns, pain intensity, pelvic floor muscle function assessed using surface EMG, and anorectal motility evaluated using anal manometry. By combining subjective clinical scales with objective physiological measurements, this study aimed to provide high-quality evidence regarding the effectiveness of adaptive, game-based EMG biofeedback therapy in the management of dyssynergic defecation. The findings are expected to contribute to the development of patient-centered, motivation-enhancing rehabilitation strategies and support the integration of game-based biofeedback approaches into standard pelvic floor rehabilitation programs.

Conditions

• Defecation Disorder

Interventions

Type	Name	Description
DEVICE	Game-Based Electromyographic (EMG) Biofeedback Therapy	Game-based biofeedback integrates real-time visual feedback with interactive tasks, allowing patients to actively control on-screen elements through appropriate muscle activation and relaxation. This approach supports motor learning principles, promotes neuromuscular adaptation, and may improve treatment compliance.
DEVICE	Sham Control	Sham EMG biofeedback therapy will be administered alongside the same standard pelvic floor rehabilitation program with identical session frequency and duration. Surface electrodes will be placed in the same anatomical locations; however, the biofeedback device will operate in demo mode, and visual feedback will not reflect actual muscle activity.

Timeline

• Start date: 2026-03-31
• Primary completion: 2026-10-31
• Completion: 2026-12-31
• First posted: 2026-03-19
• Last updated: 2026-04-06

Locations

1 site across 1 country: Turkey (Türkiye)