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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Defecation Disorder
• Intervention / Treatment: Device: Game-Based Electromyographic (EMG) Biofeedback Therapy; Device: Sham Control

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.

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tugba Gokbel, Assistant Prof, MD; Phone Number: +905442877390; Email: tugbagokbelftr@gmail.com

Study Locations

• Turkey (Türkiye)
  • Izmit
    • Kocaeli, Izmit, Turkey (Türkiye)
      • Kocaeli University
      • Contact: Feyza Alaoğlu, MD; Phone Number: +90 530 930 32 60; Email: feyzaceyhan96@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Diagnosis of dyssynergic defecation was confirmed by anorectal manometry, which demonstrated paradoxical pelvic floor muscle contraction and/or inadequate relaxation during defecation.
2. Eligibility for a pelvic floor rehabilitation program was based on a comprehensive evaluation conducted at the Physical Medicine and Rehabilitation Clinic.
3. Age between 18 and 70 years.
4. A history of chronic constipation lasting at least six months, in accordance with the Rome IV diagnostic criteria.
5. Stool consistency was classified as type 1 or type 2 according to the Bristol Stool Scale, indicating a hard stool pattern.

Exclusion Criteria:

1. Presence of communication barriers that may interfere with participation in the study.
2. Cognitive impairment affects the ability to comply with rehabilitation programs or assessments.
3. Pregnancy.
4. Presence of severe depression and/or anxiety disorder.
5. Untreated metabolic or endocrine disorders, including but not limited to diabetes mellitus, hypothyroidism, hypokalemia, and hypercalcemia.
6. Use of medications known to cause or exacerbate constipation.
7. History of spinal, rectal, or pelvic surgery, excluding cholecystectomy, hysterectomy, and appendectomy.
8. Presence of colorectal malignancy or inflammatory bowel disease.
9. Anorectal malformations or congenital pelvic floor anomalies.
10. Spina bifida, spinal cord injury, or neurological disorders, including multiple sclerosis, Parkinson's disease, dementia, or epilepsy.
11. Presence of severe cardiac or renal disease.
12. Advanced-stage hemorrhoids, anal fissures, or anal fistulas.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Biofeedback Group; Participants in the experimental group will receive game-based electromyographic (EMG) biofeedback therapy in addition to the standard pelvic floor rehabilitation program.	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.
Sham Comparator: Control Group; Participants in the control group will receive sham EMG biofeedback therapy alongside the same standard pelvic floor rehabilitation program with identical session frequency and duration.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Assessment of Constipation-Quality of Life Questionnaire	The Patient Assessment of Constipation-Quality of Life questionnaire is a validated and reliable patient-reported outcome measure developed to assess the impact of chronic constipation on the quality of life. The scale consists of 28 items grouped into four subdomains.; Physical Discomfort: Assesses constipation-related physical symptoms and bodily discomfort.; Psychosocial Discomfort: Evaluates the impact of the condition on emotional status, social functioning, and psychological well-being.; Worries and Concerns: Assesses anxiety, concerns, and illness-related perceptions associated with constipation.; Satisfaction: Evaluates patients' satisfaction with their current bowel function and treatments. Each item is scored on a 5-point Likert scale, with higher scores indicating a greater negative impact on the quality of life.	At baseline, immediately after the intervention, and 2-months after the intervention.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Constipation Severity Instrument	Constipation severity will be evaluated using the Constipation Severity Instrument, which assesses the severity of constipation-related symptoms and their impacts on daily life. It uses a five-point Likert scale (0-4), resulting in a total score from 0-73, where higher scores indicate greater severity.	At baseline, immediately after the intervention, and 2-months after the intervention.
Bristol Stool Scale	The Bristol Stool Scale categorizes human feces into seven types based on their shape and consistency, ranging from constipation (types 1-2) to diarrhea (types 5-7). This classification facilitates the objective monitoring of changes in bowel habits by assessing stool form and consistency.	At baseline, immediately after the intervention, and 2-months after the intervention.
Visual Analog Scale	Pain intensity and defecation-related discomfort will be measured using the Visual Analog Scale, a widely used tool for quantifying subjective pain perception. It is resulting in a total score from 0-100 mm, where higher scores indicate severe pain.	At baseline, immediately after the intervention, and 2-months after the intervention.
Anorectal manometry	Anorectal manometry is considered the gold standard for assessing anorectal function and for objectively monitoring physiological responses to treatment in patients with dyssynergic defecation.	At baseline, immediately after the intervention, and 2-months after the intervention.
Pittsburgh Sleep Quality Index	The Pittsburgh Sleep Quality Index is a self-reported questionnaire that assesses sleep quality over 1-month period. The measure consists of 19 individual items, creating seven components that produce one global score, and takes 5-10 minutes to complete. Each item is weighted on a 0-3 interval scale. The global PSQI score is calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, with lower scores denoting healthier sleep quality.	At baseline, immediately after the intervention, and 2-months after the intervention.

Collaborators and Investigators

• Sponsor: Kocaeli University

Publications and helpful links

General Publications

• Yamamoto S, Kawamura Y, Yamamoto K, Yamaguchi Y, Tamura Y, Izawa S, Nakagawa H, Wakita Y, Hijikata Y, Ebi M, Funaki Y, Ohashi W, Ogasawara N, Sasaki M, Maekawa M, Kasugai K. Internet Survey of Japanese Patients With Chronic Constipation: Focus on Correlations Between Sleep Quality, Symptom Severity, and Quality of Life. J Neurogastroenterol Motil. 2021 Oct 30;27(4):602-611. doi: 10.5056/jnm20135.
• Sadeghi A, Akbarpour E, Majidirad F, Bor S, Forootan M, Hadian MR, Adibi P. Dyssynergic Defecation: A Comprehensive Review on Diagnosis and Management. Turk J Gastroenterol. 2023 Mar;34(3):182-195. doi: 10.5152/tjg.2023.22148.
• Schrader R, Maschuw R. [Reduction of the surface dose of Co 60 rays in a tissue depth of 0 to 3 mm by means of a magnetic field (author's transl)]. Strahlentherapie. 1980 Apr;156(4):257-63. German.
• Rao SS, Patcharatrakul T. Diagnosis and Treatment of Dyssynergic Defecation. J Neurogastroenterol Motil. 2016 Jul 30;22(3):423-35. doi: 10.5056/jnm16060.
• Rao SS, Seaton K, Miller M, Brown K, Nygaard I, Stumbo P, Zimmerman B, Schulze K. Randomized controlled trial of biofeedback, sham feedback, and standard therapy for dyssynergic defecation. Clin Gastroenterol Hepatol. 2007 Mar;5(3):331-8. doi: 10.1016/j.cgh.2006.12.023.
• Simon MA, Bueno AM. Efficacy of Biofeedback Therapy in the Treatment of Dyssynergic Defecation in Community-Dwelling Elderly Women. J Clin Gastroenterol. 2017 Nov/Dec;51(10):e90-e94. doi: 10.1097/MCG.0000000000000794.
• Chiarioni G, Whitehead WE, Pezza V, Morelli A, Bassotti G. Biofeedback is superior to laxatives for normal transit constipation due to pelvic floor dyssynergia. Gastroenterology. 2006 Mar;130(3):657-64. doi: 10.1053/j.gastro.2005.11.014.
• Sahin M, Dogan I, Cengiz M, Unal S. The impact of anorectal biofeedback therapy on the quality of life of patients with dyssynergic defecation. Turk J Gastroenterol. 2015 Mar;26(2):140-4. doi: 10.5152/tjg.2015.4689.
• Ozkutuk N, Eser I, Bor S. Effectiveness of Biofeedback Therapy on Quality of Life in Patients with Dyssynergic Defecation Disorder. Turk J Gastroenterol. 2021 Jan;32(1):22-29. doi: 10.5152/tjg.2020.19678.
• Heymen S, Scarlett Y, Jones K, Ringel Y, Drossman D, Whitehead WE. Randomized, controlled trial shows biofeedback to be superior to alternative treatments for patients with pelvic floor dyssynergia-type constipation. Dis Colon Rectum. 2007 Apr;50(4):428-41. doi: 10.1007/s10350-006-0814-9.
• Rao SS, Valestin J, Brown CK, Zimmerman B, Schulze K. Long-term efficacy of biofeedback therapy for dyssynergic defecation: randomized controlled trial. Am J Gastroenterol. 2010 Apr;105(4):890-6. doi: 10.1038/ajg.2010.53. Epub 2010 Feb 23.
• Xu Y, Li X, Xia F, Xu F, Chen JDZ. Efficacy of a Modified Training Program of Adaptive Biofeedback Therapy for Dyssynergic Defecation in Patients with Chronic Constipation. Dig Dis Sci. 2022 Apr;67(4):1320-1327. doi: 10.1007/s10620-021-07094-z. Epub 2021 Jun 15.

Study record dates

Study Major Dates

• Study Start (Estimated): March 31, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: March 1, 2026
• First Submitted That Met QC Criteria: March 16, 2026
• First Posted (Actual): March 19, 2026

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Constipation; Electromyographic Biofeedback; Pelvic Floor Rehabilitation; Dyssynergic Defecation
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Constipation; Therapeutics; Diagnostic Techniques and Procedures; Diagnosis; Mind-Body Therapies; Complementary Therapies; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological; Electrodiagnosis; Myography; Electromyography; Biofeedback, Psychology
• Other Study ID Numbers: 2024-KAEK-02.bI.04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No